Text

Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of (Device/Sealed Source) for Model C-990. Certificate:NR-220-S-803-S
	ML20138F982
Person / Time
Issue date:	09/30/1996
From:	Steven Baggett, Thomas Rich; NRC
To:	;
References
	SSD, NUDOCS 9610180134
	Download: ML20138F982 (16)
	v • d • e

{{#Wiki_filter:_. _ _ _ - ~ _ REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HQ2: NR-0220-S-803-S DATE: September 30, 1996 PAGE 1 OF 4 s SOURCE TYPE: Radiographic Source Assembly j l j MODEL: C-990 i MANUFACTURER / DISTRIBUTOR: Nordion International Inc. I 447 March Road Kanata, Ontario, Canada i K2K 1X8 i ISOTOPE: MAXIMUM ACTIVITY: Iridium-192 140 curies (5.2 TBq) LF.AK TEST FREOUENCY: 6 months PRINCIPAL USE: (A) Industrial Radiography CUSTOM SOUPCE: YES' X NO 9610180134 960930 PDR RC SSD PDR

i 1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE 4 2 HQu: NR-0220-S-803-S DATE: September 30, 1996 PAGE 2 OF 4 SOURCE TYPE: Radiographic Source Assembly i DESCRIPTION: l The C-990 sealed source was dedicated for use in the Titan radiography exposure device. However, none of these devices were distributed. Nordion, after registering the source and device, decided not to market these items. Therefore, this certificate is for information purposes only. The radioactive Iridium-192 is contained in a single encapsulation sealed by a continuous fusion weld around its circumference. The source capsule is fabricated from Type 316L stainless steel with a minimum wall thickness of 0.031 inch (0.79 4 mm). The radioactive material is in the form of solid metallic j Iridium-192. { The source capsule is crimped onto a 0.187 inch (4.7 mm) diameter ( flexible cable (Teleflex). A 0.25 inch (6.4 mm) diameter female connector is crimped to the opposite end and allows attachment to i the male connector on the control cable. This complete assembly j is referred tc as the source assembly or pigtail assembly. i The female connector contains a machined area in the form of a step approximately 0.13 inch (3.3 mm) in diameter by 0.2 inch (5.1 mm) long. The step aligns with an internal component in the lock assembly of the Titan radiography camera which allows for automatic securing of the pigtail assembly. This source assembly meets 10 CFR Part 34 equipment requirements. LABELING: The source assembly is labeled in accordance with 10 CFR Part 34. Each source assembly is etched with the' serial number, isotope, model number, the words " Danger Radioactive" and the manufacturer's identification ("NII"). The manufacturer provides a radiography source tag to be installed by the user to the radiography camera. The tag lists the manufacturer, isotope, activity, date, model number and serial number. l

~.. - REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HQ : NR-0220-S-803-S DATE: September 30, 1996 PAGE 3 OF 4 SOURCE TYPE: Radiographic Source Assembly DIAGRAM: See Attachment 1. CONDITIONS OF NORMAL'USE: The source capsule will be used in environments associated with industrial radiography. These environs subject the source to extremely harsh environmental use conditions. This source capsule is approved for use in the Titan radiography exposure device and Model 365 radiographic source changer. This source changer is identical to SPEC C-1 source changer. PROTOTYPE TESTING: The Model C-990 was found (by engineering analysis) to meet the requirements for Special Form Radioactive Material, and of ANSI N542-1977 Sealed Source Classification 77C43515. The source assembly was installed in Nordion International, Inc's Titan radiography exposure device and was subjected to the requirements of ANSI N432-1980. The source assembly passed the tests (tensile test and endurance test). EXTERNAL RADIATION LEVELS: The expected radiation levels using a radiation constant of 0.48 R/h/Ci at one meter and the inverse square law are as follows: Distance From Source Radiation Dose 5 cm (1.97 in) 26,880 R/hr (268.80 Sv/hr) 30 cm (11.8 in) 747 R/hr ( 7.47 Sv/hr) 100 cm (39.4 in) 67 R/hr (- 0.67 Sv/hr) OUALITY ASSURANCE AND CONTROL: Nordion employs a quality control program to insure that each component is manufactured to the specifications furnished to the NRC. This program complies with the terms and conditions of Subpart H, 10 CFR Part 71. ~-

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HQ : NR-0220-S-803-S DATE: September 30, 1996 PAGE 4 OF 4 SOURCE TYPE: Radiographic Source Assembly OUALTTY ASSURANCE AND CONTROL (continued: Prior to distribution, each source is tested for leakage using a hot water bubble test procedure. Each source is also tested for contamination by assaying smears of the surface based on a limit of 0.5 nCi (18.5 Bq). LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

This registration sheet and the infornation contained in the reference shall not be changed without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

The C-990 sealed source was dedicated for use in the Titan radiography exposure device. However, none of these devices were distributed. Nordion, after registering the source and device, decided not to market these items. Therefore, this certificate is for information purposes only.

REFERENCES:

The following supporting documents for the Nordion C-990 source assembly are hereby incorporated by reference and are made a part of this registration document.

Nordion International Inc.'s application dated November 23, 4

1993, and letters dated September 19, 1996, July 12, 1994, December 19, 1994, and January 18, 1995, with enclosures thereto. ISSUING AGENCY: U.S. Nuclear Regulatory Commission Date: September 30, 1996 Reviewer: Thomas W. Rich Date: Sectember 30, 1996 Concurrence: 'N ~ . Steven EC'Baggett

. _- _= i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HL.: NR-0220-S-803-S DATE: September 30, 1996 ATTACHMENT 1 SOURCE TYPE: Radiographic Source Assembly A 1.805 in. (46 mm) 0.310 in. Dia. (8 mm) 7.24 in. (184 mm) The C-990 Sealed Source

@INTERNATIONALI \\t i 1995 September 19 I i Mr. Steve Baggett, Section Leader 2 Division of Industrial and Medical Nuclear Safety, US Nuclear Regulatory Commission Washington, DC 20555

Dear Mr. Baggett,

.n RE: Device Registration NR-220-D-109-S (Titan Gamma Radiography Exposure Device) Scaled Source Registration NR-220-D-110-S (C-990 Sealed Source Assembly) e i The purpose of this letter is to advise you that Nordion International will not manufacture the Titan Gamma Radiography Exposure Device or its dedicated C 990 Sealed Source Assembly. 4 No units have been distributed to customers. Units that were manufactured as part of the development program have been rendered inoperable. We request that you render these licenses inactive. Sincerely, Co m A h ly ma rk V. Govindapillai, Manager, Regulatory Affairs cc. Mr. Cass R. Chappeli, Section Leader Cask Certification Section, Transportation Branch, Division ofIndustrial and Medical Nuclear Safety US Nuclear Regulatory Commission Washington D.C 20555 fdb \\ \\ 447 March Road, Kanata. Ontario, Canada K2K 1X8 Tel.: (613) 592-2790 Telex: (053) 4162 Fax: (613) 592-6937 -S$f&wGeaff 9ff. kt

PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION pes) REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all related letters /appecations and drawings to: The Sealed Source Safety Section, ATTN; CNef. OWFN Mail Stop 6 H3. Change the License Tracking System milestone to 19 and assign to reviewer code I-5. ) NOTE: Retain a copy of this request with the application and background files. 1 REQUkSTER REGION / LOCATION: Mg W ]l R 11 111 IV UV R HQ R LFDCB i TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate) QSOURCE REVIEW ] AMENDMENT OF APPUCANTS NAME REGISTRATION SHEET I) Mall CONTROL NUMBER (S) DEVICE REVIEW f R ~'Z7.0 0 NO E LETTER /APPUCATIQN DAT[g UCENSE NUMBER (S) CUSTOM REVIEW f 7ft l'M yy7 Afo^g & CouuemS. n.,+, 0.&& /0~ 4 k2k tw \\ FOR 8888 USE ONLY CItflEWER MODELNUMBER5 WN 97-97 NUMBER ASSIGNED DATE RECEIVED DATE ASSIGNED DATE TO FEES]Y7~ l o/z/9Y t 0/2 TYPE OF ACT10N (Indicate the number of each type) WOMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM) SOURCE (9C) DEVICE (9A) SOURCE (90) DEVICE (98) NEW NEW NEW NEW [ AMENDMENT AMENDMENT AMENDMENT AMENDMENT j LICENSING ACTION REQUIRED IF KNOWN NO O SAFETY EVALUATION REQUIRED NO FEES REQUIRED ) OTHER (SpecWy) TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY ~ NEW REGISMATION - RODUCT INACM - NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY \\ Q (,, g ]9A 98 X 9C 90 cuount RECEIVED [h '7 CHECK NUMBER MATANN UPDATED w - AS REQUIRED cnTE OF CHECK loo /.5 j MATSYS UPDATED h( AS REQUIRED APPROVED BY DATE RETURN DATE L-COMMENTS alalW l ( NRC FORM $67 (6-93)

p( g4 s' 1 PAGEt h NRC FORM $67 U. S. NUCLEAR REGULATORY COMMSSION (4 03) REQUEST FOR A SEALED SOURCE OR l DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all r3 fated letters /spplications and drawings to: The Sealed Source Safety Section, ATTN: Chief, OWFN Mail Stop 6 H3. Change the License Traciong System milestone to 19 and assign to reviewer code I-5. NOTE: Retain a copy of this request witn the application and background files. REQUESTER REGION / LOCATION: /bg6 M lI il lil IV RV R HQ R LFDCB TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate) C#PUCANTS NAME SOURCE REVIEW ] AMENDMENT OF l REGISTRATION SHEET N BER(S) uCa. CONTROL NUMBER (S) DEVICE REVIEW ,.(j d ~210 0 ll0 5 LETTER /APPUCATK)N DAT9 UCENSE NUMBER (S) CUSTOM REVIEW i 9// 7/9f '/ COMMENTS. y(t? A'0^ h n Ac,. Os+0N fod k2k (w FOR SSSS USE ONLY l REVIEWER MODEL NUMBERS NUMBER ASSIGNED $ l~ W 93-97 DQTE RECEIVED DATE AS$1GNED DATE TO FEhS l77 i 6/t/W i0 TYPE OF ACTION (Indicate the nurnber of each type) jf;OMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM) SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (98) NEW NEW NEW NEW g AMENDMENT AMENDMENT AMENDMENT AMENDMENT IO SAFETY EVALUATION REQUIRED ] LICENSING ACTION REQUIRED IF KNOWN NO FEES REQUIRED NO j OTHER (Spec #y) ~ TOTAL NUMBER OF NOTES REVIEW HOURS NUMBF.R OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS i FOR BILLING PURPOSES ONLY 5 m ] NEW REGISTRATION - PRODUCT INACTIVE - NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY \\ /7_ (, j-/- 19A U 9B 7 BC 90 QMOUNT RECEIVED [h 'M CHECK NUMBER MATANN UPDATED 1.%., ~ AS REQUIRED .I DQTE OF CHECK LOG / 5(o MATSYS UPDATED [/ / AS REQUIRED CPPROVED BY DATE RETURN DATE L ain/W ~ COMMENTS f NRC FORM $67 (8-93) b 2

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t 7131326 U.S. Pm ' AGE t _I f i Mr. Steve Baggett, Section Leader i Division ofIndustrial and Medical Nuclear Safety, US Nuclear Regulatory Commission Washington, DC ~ ~ 20555 f 4 p g liilillliiiililiililiililiiilli J 1 j i

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---n,_---.__ 5 ~

September 30, 1996 Mr. V. Govindapillai Nordion International Inc. 447 March Road Kanata, Ontario, Canada K2K 1XS

Dear Mr. Govindapillai:

Based on the information submitted in your letter dated september 19,1995, we have inactivated the Model Titan gamma radiography exposure device (NR-0220-D-109-S) and Model C-990 (NR-0220-D-110-S) sealed source assembly. In order to reflect their inactive status, certificates NR-0220-D-109-S and NR-0220-S-110-S have been assigned new 4 registration numbers, NR-0220-D-802-S and NR-0220-S-803-S, respectively. Please review the registration certificates (copies enclosed) in their entirety and notify us immediately if there are any errors or ? missions. If you have any questions, please contact me at (301) 415-7893 or Mr. Steven Baggett at (301) 415-7273. Sincerely, l-l Thomas W. Rich, Mechanical Engineer Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards

Enclosure:

As stated cc w/ encl: Skimberley, LFDCB Distribution: SSSS r/f SSD-95-96 SSD-95-97 NE01 ( SSD File # NR-0220-D-802-S, NR-0220-S-803-S DOCUMENT NAME: NR220802. cmp Tge#y a copy of this docuenent, indicate in the boa: 'C' = Copy without attachment / enclosure 'E" = Copy with attachment > enclosure "N" = No copy OFFICE IMAB ( NAME Trich f.ep.. DATE 9/N96 OFFICIAL RECORD COPY %!ClL *4'IE Iy. 3ltf s

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-[fD-S DATE: PAGE 1 OF 5 DEVICE TYPE: Radiographic Source Assembly MODEL: C-990 MANUFACTURER / DISTRIBUTOR: Nordion International Inc. 447 March Road Kanata, Ontario, Canada K2K 1X8 ISOTOPE: MAXIMUM ACTIVITY: Iridium-192 140 curies (5.2 TBq) LEAK TEST FREOUENCY: 6 Months PRINCIPAL USE: (A) Industrial Radiography CUSTOM DEVICE: YES X NO I l Revision 0, January 17, 1996 G \\SSSS\\NR220110.SSD

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-j1y-S DATE: PAGE 2 OF 5 DEVICE' TYPE: Radiographic Source Assembly DESCRIPTION: The radioactive iridium-192 is contained in a single encapsulation sealed by a continuous fusion weld around its circumference. The source capsule is fabricated from Type 316L stainless steel with a minimum wall thickness of 0.031 inch (0.79 mm). The radioactive material is in the form of solid metallic iridium-192. The source capsule is crimped onto a 0.187 inch (4.7 mm) diameter flexible cable (Teleflex). A 0.25 inch (6.4 mm) diameter female connector is crimped to the opposite end and allows attachment to the male connector on the control cable. This complete assembly is referred to as the source assembly or pigtail assembly. The female connector contains a machined area in the form of a step approximately 0.13 inch (3.3 mm) in diameter by 0.2 inch (5.1 mm) long. The step aligns with an internal component in the lock assembly of the Titan radiography camera which allows for automatic securing of the pigtail assembly. This source assembly meets 10 CFR Part 34 equipment requirements. LABELING: The source assembly is labeled in accordance with 10 CFR Part 34. 1 Each source assembly is etched with the serial number, isotope, j model number, the words " Danger Radioactive" and the i manufacturer's identification ("NII"). i l The manufacturer provides a radiography source tag to be installed by the user to the radiography camera. The tag lists I the manufacturer, isotope, activity, date, model number, and serial number. I l l Revision 0, January 17, 1996 G:\\SSSS\\NR220110 SSD

a a r~= a u j REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE i NO..1 NR-0220-S-{%p-S DATE: PAGE 3 OF 5 DEVICE TYPE: Radiographic Source Assembly 4 DIAGRAM: See Attachment 1 CONDITIONS OF NORMAL USE: 4 The source capsule will be used in environments associated with industrial radiography. These environs subject the source to extremely harsh environmental use conditions. This source capsule is approved for use in the Titan radiography exposure device and Model 365 radiographic source changer. This source changer is identical to SPEC C-1 source changer. PROTOTYPE TESTING: The Model C-990 was found (by engineering analysis) to meet the requirements for Special Form Radioactive Material, and of ANSI N542-1977 Sealed Source Clar -ification 77C43515. l The source assembly was installed in Nordion International, Inc.'s Titan radiography exposure device and was subjected to the requirements of ANSI N432-1980. The source assembly passed the j tests (tensile test and endurance test). j EXTERNAL RADIATION LEVELS: The expected radiation levels using a radiation constant of 0.48 R/h/Ci at one meter and the inverse square law are as follows: Distance From Source Radiation Dose 5 cm (1.97 in.) 26,880 R/hr (268.80 Sv/hr) 30 cm (11.8 in.) 747 R/hr (7.47 Sv/hr) 100 cm (39.4 in.) 67 R/hr (0.67 Sv/hr) Revision 0, January 17, 1996 G:\\SSSS\\NR220110.SSD

.== REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-(($-S DATE: PAGE 4 OF 5 DEVICE TYPE: Radiographic Source Assembly OUALITY ASSURANCE AND CONTROL: Nordion employs a quality control program to insure that each component is manufactured to the specifications furnished to the NRC. This program complies with the terms and conditions of Subpart H, 10 CFR Part 71. Prior to distribution, each source is tested for leakage using a hot water bubble test procedure. Each source is also tested for contamination by assaying smears of the surface based on a limit of 0.5 nCi (18.5 Bq). LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: The source assembly shall be distributed only to persons specifically licensed by the NRC or an Agreement State. The source shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting the presence of 0.005 microcurie (185 Bq) of removable contamination. The source assemblies shall not be subjected to environmental or other conditions of use which exceed the ANSI-N542 classification of 77C43515. Handling, storage, use, transfer, and disposal: to be determined by the licensing authority. In view that these source assemblies exhibit high dose rates, the sources should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures. The Model C-990 source assembly may only be used in conjunction with the Titan exposure device, Model 365 source changers, or other devices and uses as specified in a registration certificate issued by the NRC or Agreement State. l This registration sheet and the information contained in the reference shall not be changed without the written consent j of the NRC. Revision 0, January 17, 1996 G:\\SSSS\\NR220110.SSD

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO : NR-0220-S-[fy-S DATE: PAGE 5 OF 5 DEVICE TYPE: Radiographic Source Assembly SAFETY ANALYSIS

SUMMARY

' Based on our review of the information and test data cited below, we conclude that the Model C-990 source assembly is acceptable for licensing purposes. Furthermore, we conclude that Model C-990 source assembly would be expected to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.

REFERENCES:

The following supporting documents for the Nordion C-990 source assembly are hereby incorporated by reference and are made a part of this registration document:

Nordion International Inc.'s application dated November 23, l

1993, and letters dated July 12, 1994, December 19, 1994, and January 18, 1995, with enclosures thereto ISSUING AGENCY: U.S. Nuclear Regulatory Commission Date: Reviewer: Thomas W. Rich Date: Concurrence: Steven L. Baggett Revision 0, January 17, 1996 Gi\\SSSS\\NR220110,SSD

1 l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-;1$-S DATEE-ATTACHMENT 1 4 d 4 R Revision 0, January 17, 1996 Gr\\SSSS\\NR220110.SSD

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1 j gr / Canadian Standards Association g,, _,, _g O factory Test: The equipment at the conclusion of manufacture and before shipment shall witnatand for one minute without breakdowm, the application of 900v ac between live parts and exposed non-eurrent-carrying metal parts. The factory test may be made at existing room temperature. l Each transformer shall be subjected ta the following dielectric strength tests l for a period of one minute without breakaan: l l 1000v ac plus twice the maximum rated voltage of that winding applied between l each winding and the core and enclosure with all other windings grounded to the j core and the enclosure; except that if the maximum low voltage does not exceed 30v the test voltage shall be 500v ae. As an alte rnative, a potential 20 per cent higher may be applied for one second. l l t ,lO va,, t, s. :,, ATOMIC ENERGY OF CANADA, LIMITED i COMVfROAL PRU0lif f S OTTAWA CAN AD A rada >-[,,, r,, e, 3.g b.)'Ai I SER NO Vods pygg g g DATE gyg gyp 3 l l l

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d 4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HD : NR-0220-S-110-S DATE: February 13, 1995 PAGE 1 OF 5 SOURCE TYPE: Radiographic Source Assembly P MODEL: C-990 MANUFACTURER / DISTRIBUTOR: Nordion International Inc. 447 March Road Kanata, Ontario, Canada K2K 1X8 ISOTOPE: MAXIMUM ACTIVITY: Iridium-192 140 curies (5.2 TBq) LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (A) Industrial Radiography CUSTOM SOURCE: YES X NO ,-95033200483950213 S/ e.;t PDR.,RC.f)tegjo, PDR SSD.. *)'*

~.. _ ~ _... _ _. _ _ - _ _ v. REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION O' SEALED SOURCE HQ : NR-0220-S-110-S DATE: February 13, 1995 PAGE 2 OF 5 SOURCE TYPE: Radiographic Source Assembly DESCRIPTION: The radioactive Iridium-192 is contained in a single encapsulation sealed by a continuous fusion weld-around its circumference. The source capsule is fabricated from Type 316L stainless steel with a minimum wall thickness of 0.031 inch (0.79 mm). The radioactive material is in the form of solid metallic Iridium-192. The source capsule is crimped onto a 0.187 inch (4.7 mm) diameter flexible cable (Teleflex). A 0.25 inch (6.4 mm) diameter female connector is crimped to the opposite end and allows attachment to the male connector on the control cable. This complete assembly is referred to as the source assembly or pigtail assembly. The female connector contains a machined area in the form of a step approximately 0.13 inch (3.3 mm) in diameter by 0.2 inch (5.1 mm) long. The step aligns with an internal component in the lock assembly of the Titan radiography camera which allows for automatic securing of the pigtail assembly. This source assembly meets 10 CFR Part 34 equipment requirements. LABELING: The source assembly is labeled in accordance with 10 CFR Part 34. Each source assembly is etched with the serial number, isotope, model number, the words " Danger Radioactive" and the manufacturer's identification ("NII"). The manufacturer provides a radiography source tag to be installed by the user to the radiography camera. The tag lists the manufacturer, isotope, activity, date, model number and serial number. DIAGRAM: See Attachment 1.

l f l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE I HQ : NR-0220-S-110-S DATE: February 13, 1995 PAGE 3 OF 5 SOURCE TYPE: Radiographic Source Assembly CONDITIONS OF NORMAL USE: The source capsule will w used in environments associated with industrial radiography. These environs subject the source to extremely harsh environmental use conditions. This source capsule is approved for use in the Titan radiography exposure device and Model 365 radiographic source changer. This source changer is identical to SPEC C-1 source changer. PROTOTYPE TESTING: The Model C-990 was found (by engineering analysis) to meet the requirements for Special Form Radioactive Material, and of ANSI N542-1977 Sealed Source Classification 77C43515. The source assembly was installed in Nordion International, Inc's Titan radiography exposure device and was subjected to the requirements of ANSI N432-1980. The source assembly passed the tests (tensile test and endurance test). EXTERNAL RADIATION LEVELM: The expected radiation levels using a radiation constant of 0.48 R/h/Ci at one meter and the inverse square law are as follows: Distance From Source Radiation Dose 5 cm (1.97 in) 26,880 R/hr (268.80 Sv/hr) 30 cm (11.8 in) 747 R/hr ( 7.47 Sv/hr) 100 cm (39.4 in) 67 R/hr ( 0.67 Sv/hr) OUALTTY ASSURANCE AND CONTROL: Nordion employs a quality control program to insure that each component is manufactured to the specifications furnished to the NRC. This program complies with the terms and conditions of Subpart H, 10 CFR Part 71. Prior to distribution, each source is tested for leakage using a hot water bubble test procedure. Each source is also tested for ( contamination by assaying smears of the surface based on a limit j .of 0.5 nCi (18.5 Bq). ? vsn r ~c

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE EQ : NR-0220-S-110-S DATE: February 13, 1995 PAGE 4 OF 5 SOURCE TYPE: Radiographic Source Assembly LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

The source assembly shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
The source shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting the presence of 0.005 microcurie (185 Bq) of removable contamination.

The source assemblies shall not be subjected to environmental or other conditions of use which exceed the ANSI-N542 classification of 77C43515. Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. In view that these source assemblies exhibit high dose rates, the sources should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures. The Model C-990 source assembly may only be used in conjunction with the Titan exposure device, and model 365 source changers, or other devices and uses as specified in a registration certificate issued by the NRC or Agreement State. This registration sheet and the information contained in the reference shall not be changed without the written consent of the NRC. SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data cited below, we conclude that the Model C-990 source assembly is acceptable for licensing purposes. Furthermore, we conclude that Model C-990 source assembly would be expected to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE HQt: NR-0220-S-110-S DATE: February 13, 1995 PAGE 5 OF 5 SOURCE TYPE: Radiographic Source Assembly

REFERENCES:

The following supporting documents for the Nordion C-990 source assembly are hereby incorporated by reference and are made a part of this registration document. Nordion International Inc.'s application dated November 23, 1993, and letters dated July 12, 1994, December 19, 1994, and January 18, 1995, with enclosures thereto. ISSUING AGENCY: U.S. Nuclear Regulatory Commission Date: February 13. 1995 Reviewer: W Thoma ich l Date: February 13. 1995 Concurrence: / prJo'hnWIL"ubinski

.=..- .~. i i i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE HQ_ : NR-0220-S-110-S DATE: February 13, 1995 ATTACHMENT 1 l a SOURCE TYPE: Radiographic Source Assembly a i i 1 4 1.806 in. (46 mm) O.310 in. Dia. (8 mm) i i 1 4 7.24 in. (184 mm) The C-990 Sealed source i s I i 4 i j i i a

1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE i 111.: NR-0220-S-110-S DATE: February 13, 1995 ATTACHMENT 1 SOURCE TYPE: Radiographic Source Assembly 2 I 1.805in. (46 nwn) O.310 in. Dis. (8 rnm) 7.24 in. (184_mm) The C-990 Sealed Source

~ ~ ~ ~ a_. ; r_1c n33m TR-9412-C990 (A) ,l TABLE OF CONTENTS

1.0 INTRODUCTION

1 2.0

SUMMARY

DATA 2 3.0

SUMMARY

DESCRIPTION.............................. 3 4.0 DETAILS OF CONSTRUCTION AND USE 3

5.0 REFERENCES

5 LIST OF APPENDICES Appendix 1. C-990 Specification Sheet (Rev. B) 6 Appendix 2. Nordion Specification IS/TS 0010 C000(C) 7 Appendix 3. Nordion Specification IS/DS 0055 N990(B) 8 Appendix 4. Special Form Radioactive Material 9 Certificate No CDN/0001/S (Rev. 12) Appendix 5. USNRC Quality Assurance Program 10 Approval (Rev. 1) Appendix 6. Engineering Drawings for the C-990 11 DEC 1994 ASM# 9-? N?O ff.

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1.0 INTRODUCTION

This report is generated in support of an application for radiation safety evaluation and; registration of the C-990 sealed source assembly. It is shown in Specification Sheet C-990. (See Appendix 1.) The C-990 is used in the Nordion Titan Gamma Radiography Exposure Device. It may contain up to 140 Ci (5.2 TBq) of Ir-192. It meets all requirements for Special Form Radioactive Material. When installed in the Titan, the C-990 meets all the requirements of 10 CFR Parts 34 and 71. 1 i 1 I i 1 DEC 1994

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SUMMARY

DATA DATE: 1994 December 19 MANUFACTURER / DISTRIBUTOR: Nordion International Inc., 447 March Road, Kanata, Ontario, Canada K2K 1X8 i SEALED SOURCE TYPE: Radiography Source Assembly MODEL NUMBER: C-990 OTHER COMPANIES INVOLVED: None RADIONUCLIDE: Ir-192 MAXIMUM ACTIVITY: 140 C1 (5.2 TBq) LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (A) Industrial Radiography CUSTOM SEALED SOURCE: No s ) \\ 2 DEC 1994

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TR-9412-C990 (A) 4 3.0

SUMMARY

DESCRIPTION The C-990 consists of solid Ir-192 pellets singly encapsulated in i a two piece type 316L capsule. The capsule.is sealed by a continuous fusion wcld around its circumference. The external dimensions of the capsule are 0.187 in (4.7 mm) in diameter and 0.775 inches (19.7 mm) in length. The minimum wall thickness is 0.031 in (0.79 mm). The sealed capsule is crimped onto a 0.187 inch (4.7 mm) diameter flexible cable. A two part female connector 0.25 in (6.4 mm) in diameter and 1.32 in (33.5 mm) in length is crimped to-the ,j opposite end of the cable. The two parts of the female connector are secured using a spring pin. An intermediate locking ball 0.305 in (7.7 mm) in diameter and 0.210 in (5.3 mm) in length is crimped to the flexible cable 1.805 in (45.8 mm) from the end of j the female connector. i The C-990 is manufactured in accordance with Nordion. technical 4 i specification IS/TS 0010 C000. (See Appendix 2.) It is shown in Nordion specification sheet C-990. (See Appendix 1.) i 4.0 DETAILS ON CONSTRUCTION AND USE i Conditions of Use l i This source is used for industrial radiography and is subjected to environmental conditions typically associated with these i applications. The environment is considered to be harsh. l Details of Construction j The C-990 is fabricated in accordance with the engineering i drawings listed in Table 1. Copies of the-e engineering drawings can be found in Appendix 6. l Table 1. List of Engineering Drawings for the C-990 A03334 A03335 '~ A16829 A16849 i A17714 l A17720 K122213-600 K122213-601 K122213-602 1 l 4 I 3 DD: 1994 I T

m m j Hip I 9 1 7 TR-9412-C990(A) -) Labelling TheLC-990 is engraved as described in engineering drawing K122213-600. This includes the isotope (Ir-192), the. capsule model number (C-990), the manufacturer (NII) and the words " DANGER RADIOACTIVE." Each source is shipped with a source tag that includes the activity of the radioactive contents at the time of shipment. The source tag is shown in drawing A17720. (See Appendix 6.) Testing of Prototypes The C-990~has been tested as described in IS/DS 0055 N990. (See Appendix 3.) It has been found to meet the requirements for Special Form Radioactive Material, and of ANSI Sealed Source Classification C43515. (See Appendix B of IS/DS 0055 N990) It also meets all performance requirements of ANSI N432-1980 and 10 CFR Parts 34 and 71. The test results are found in Nordion Technical Report TR-9302-N990(B).[1] Special Form Radioactive Material Certificate CDN/0001/S is found in Appendix 4. Radiation Levels Table 2 summarizes the results of calculations done using a gamma radiation constant of 0.48 R/h/Ci at one meter and the inverse square law: Table 2. Summary of Radiation Levels from a 140 Ci C-990 i DISTANCE FROM SOURCE RADIATION DOSE (cm) (in) (R/h) (Sv/h) 5 1.97 26,880 268.8 30 11.8 747 7.47 100 39.4 67 .67 4 DEC 1994

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y, q TR-9412-C990(A) i i Quality Assurance and Control 1 Nordion~has submitted a quality assurance and control program that has been accepted by the USNRC. -(Appendix 5) The tests completed on source assemblies prior to welding are described in Nordion specification IS/TS'0010 C000.(Appendix 2) Prior to distribution, each source is tested for leakage using a hot water bubble test procedure. Each source is also tested for contamination by assaying smears of the surface based on a limit of 0.5 nCi (18.5 Bq).

5.0 REFERENCES

(1) Test Report for the Titan Gamma Radiography Exposure Device, Nordion International Technical Report no. TR-9302-N990(B), October 1993 i () 5 DEC 1994

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~ p.z- -~- - Parts list ,' *[ 7 4 1. Control cable 2. D898 Male connector 4 3. D899 Female connector _ j ( } 4. Locking pin ' 5. Locking collar 6. Cornpression spring 2 7. Spring pin 8. Connector cap 9. Crtrnp i 10. Crirnped and threaded locking ball 11. Pig tail cable 12. Critnp .i 14. L rial: *lt a a 15. Baso capsm 4 i 5 .- f- ~6 ' t i 1.805 in. (46 mm) [ l4 8 4 1 _g I .I f -- 10 0.310 in. Dia*. (8 mm) 6 7.24 in. (184 mm) Notes 1. Conforms to IAEA Spedal Form requirernents (AECB Certificate No. CDN/0001/S) 2. Manufactured to Nordion Specification jj 2' IS/TS 0010 C000 3. Used with the Titan Gamma Radiography Exposure Device 4. The ferrale connector has the following information engraved: Q DANGER gyg 13 RADIOACTIVE h nil - 14 IR192 C990

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SERIAL NO. (as specified) C4 16 Radiography Capsule UNCONTROLLED COPY 447 March Road P.O Box 13S00 Kanata. Ontano, Canada, K2K 1X8 Te+ (613) $92 2790 e Fax (613) $924937 e Telex. 0534162 REF DWG K122213soo NOT M B A L u.}yn gos,4 THl3 DRAMNG IS THE PROPERTY OF NORDION INTERNATIONAL INC. AND IS SUBMITTED FOR CONSIDERATION ON THE UNDERSTANDING THAT THERE SHALL CHECKED AP OV ~ C-990 BE NO EXPLOITATION OF ANY INFORMATION CONTAINED HEREIN EXCEPT NTH B THE SPECIFIC WRITTEN AGREEMENT OF NORDION INTERNATIONAL INC. SHEET 1 OF 1 W'-

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Tel:(61:)592-2790, Telex:(053) 4162, Telefax'613)592-6937 ( TERNATIONALINC. (} TECHNICAL SPECIFICATION i IS/TS 0010 C000 Technical Specification for Radioisotope Capsules and Sources CURRENT DATE: AUG 93 j DATE, ISSUE COMMENTS /AFFECTED PAGE PREPARED BY REVIEWED BY APPROVED BY 87 May 0 Original Issue R. Beekmans T. Simpson W.H. Pettipas f 89 Aug A DC 90197 (General Revision) A.W. Gunter G.A. Burbidge/ G.M. Defalco i i A. Shewchenko ) 92 Feb B DC 90289 G.A. Burbidge T. Simpson/ G.M. Defalco l R. Goddard l 4 j 93 Aug C DC 90464 B. Menna G.A. Burbidge j G.M. Defalco / b V ( ) l i i ) 1 I I i This document contains information proprietary to Nordion International Inc. Any disclosure or use of this information or any reproduction of this document other than the specified purpose for which it is intended is expressly prohibited except as Nordion International Inc. may otherwise agree in writing. NOTE: The portion of this text affected by the changes is indicated by a vertical line in the margins of the pages. IS0010C1 l UNCONTRC LLtU UUFY NOT FOR GENERAL USE

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= =E e ., es. ; .a.i.aw.:,,.. n e . IS/IS 0010 C000 - ;w; I l ( .mTable of Contents, 1 S CO P E.............................................. 4 1-1 Definitions....... '............................... 4 2 G ENERAL INFORMATION.......................... 4 2-1 Applicable Capsules & Sources..................... 4 l l 2-2 Applicable Drawings............................. 4 2-3 Applicable Standards..'........................... 4 2-4 Nordion Specifications............................ 4 1 3 REQ UIREM CNTS.................................... 4 1 i 3-1 General......................................... 4 3-2 Code Requirements........ :..................... 6 3-3 Manufacturing Drawings........................ 6 3-4 Storage and Handling of Materials and Components.. 6 3-5 Manufacturing Requirements...................... 6 3-5-1 Manufacturing Control Plan................ 6 3-5-2 Inactive Welding.......................... 6 ( 3-5-3 Active Welding.................... ... 6 l 3-5-4 Fitting and Machining..................... 8 3-5-5 Tooling................................... 8 3-5-6 Heat Treating.............................. 8 i 3-5-7 Crimping............................... 8 l 3-5-8 Surface Finish and Cleanliness.............. 8 3-5-9 Cleaning, Packing, Storage & Shippin g.......................... .8 t l l l l l l l I l l lof16 UNCONTROLLED CO!PXug NOT FOR GENERAL USE

!S/150010 C000 4 INSPECTION, TESTS AND DOCUMENTATION. 8 4-1 Non-Conformance and Corrective Action..... 9 4-2 Reinspection. 9 4-3 Materials and Component Inspection............ 9 4-3-1 Raw Materials.... .. 9 4-3-2 Purchased Mechanical Components...... 9 4-4 Macro Examination of Welds. 9 4-4-1 Sectioning.. ..9 4-4-2 Finishing. .. 9 4-4-3 Etching.. 9 4-4-4 Requirements........ ................ 9 4-5 Tensile Crimp Testing - Production............. 9 4-5-1 In Process Testing... 10 4-6 First-Off Testing & Inspection.. ......... 10 4-7 Hardness Testing. ............ 12 4-8 Documentation..... ......... 12 APPENDIX A Applicable Capsules and Drawings. . 13 APPENUlXU Applicable Standards......... ...... 15 APPENDIX C Applicable Nordion Specifications and Procedures........... .............. 16 UNCONTROLLED COPY 93 Aug 2of16 NOT FOR GENERAL USE

++ ,4 +, ; ^- = ;;=.: ; c = ; 4,. g # 2 f ','i %. ' 4 y IS/IS 0010C000 4 . List of Tables l ^ ( e;. r T7't -d, s Table 1 Matrix of' pplicable Sections of this Specification...........'5] H ,e, A l ,,3 Table 2 i ' Pull Tested Sources..................................... 10 ' f . Table 3 Crimp Failure loads.................................... 10 List of Illustrations Figurel Weld Penetration....................................... 7 Figure 2 TypicalPullTested Source......................... 11 t i 1 l 3cf16 UNCONTROLLED CQfLg NOT FOR GENERAL USE

IS/TS 0010 C000 1 SCOPE li APP cable issues are those effective on the date of tendering documents. In the event that certain This specification establishes the technical requirements requirements or data on the drawings conflict with the for the manufacture, assembly, inspection and delivery requirements of this specification, the governing of radioisotope sources & capsules. requirements shall be at the discretion of the Purchaser. It also covers the complete assembly, including all The Vendor shall notify the Purchaser of any error or sub-assemblies and components of the sources and omission in the applicable drawings. Failure to do so capsules, whether subcontracted or not. The Vendor shall not relieve the Vendor 4 any responsibility to shall be responsible for ensuring that all applicable produce a product that is acceptable to the Purchaser, sections of this specification have been met. and that meets all the requirements called for in Section 4. 1-1 Definitions The following definitions apph in this e rification: The documents listed in Appendix B form an integral Capsule: Components comprisiny, e e source part of this specification, where applicable. They do not assembly. however, override the requirements of this specification. j If there are equivalent standards that the Vendor prefers, 1 Vendor: The party who agrees to supply the such standards must be submitted to the Purchaser for materials or perform the services as approval. Approval by the Purchaser shall not relieve required by Nordion Intemational Inc. the Vendor from his responsibihty to meet the Purchaser: NordionIntemationalInc. Source: A term used to describe an encapsulation 2-4 Nordion Specifications that contains sealed radioactive material. The Nordion specifications and procedures listed in i Appendix C are primarily for use by Nordion. Should NOTE the Vendor be required to meet any of these standards, To avoid repetition in this specyication the he shall be given a copy of the applicable standards and words " sources" and " capsules" have been be so advised with the Request for Quotation. 1 used interchangeably. All requirements apply to both equally. 3 REQUIREMENTS i J 2 GENERALINFORMATION 3-1 General l 2-1 Applicable Capsules & Sources All components as shown on the applicable drawings shall be fabricated, assembled, inspected, and prepared 3 This Technical Specification applies to sources and for delivery by the Vendor as specified herein. Final l czpsules listed in Appendix A. Detailed manufacturing acceptance of the source assembly shall be dependent and inspection requirements are detailed in Sections 3 upon passing all tests and checks specified in Section 4 and 4 of this specification. As not all requirements apply of this speci6 cation. The Vendor shall maintain a close to all c psules and sources, Table 1 is provided, which liaison with an authorized Nordion representative j gives a matrix of the applicable specifications for each of throughout all phases of the work. l the c:psules. 2-2 Applicable Drawings ) 9 The drawings for the capsules are listed in Appendix A, lwhich is an integral part of this Specification. The ":c~" O WUUUdC UW 4 ot 16 i. NE NOT FOR GFNFR AI IIRF j

~,.,g , y,, 3 g4 tyi Mdyjj.f. + 6 19, tsns0010cooo + i q;1,, t; m-Table 1 Matrix of AppHeable Sections of this Specification ' 4 ' #ri o!; - / ! r CAPSULE 3.1 u u 3.4 ui um use u4 a.u u.s 3.u uJ u.e to L1 u a w ts-u 4.7 4.s C-324 Type 1 X .X X X X X X X X X X X X X X X X C 324 Type 2 X X X X X X X X X X X X X X X X X C 265 X X X X X X X X X X X X X X X C 181 X X X X X X X X X X X X X X X X X j XC 192 X X X X X X X X X X X X X X X X X X X C-204 X X X X X X X X X X X X X X X X X l XC-234 X X X X X X X X X X X X X X X X X C 245 X X X X X X X X X X X X X X X X X X X XC-266 X X X X X X X X X X X X X X-X X X X X C 337 X X X X X X X X X X X X X X X X X X X X X C 340 X X X X X X X X X X X X X X X X X X X X X C343 X X X X X X X X X X X X X X X X X X X X X C 349 X X X X X X X X X X X X X X X X X C-352 X X X X X X X X X X X X X X X X X C 164 X X X X X X X X X X X X X X X X X TC-346 X X X X X X X X X X X X X X X X X C-357 X X X X X X X X X X X X X X X X X C-359 X X X X X X X X X X X X X X X X X X X X X C-361 X X X X X X X X X X X X X X X X X X X X X j C-369 X X X X X X X X X X X X X X X X X X X X X C-990 X X X X X X X X X X X X X X X X X X X X X C 140 X X X X X X X X X X X X X X X X X C 163 X X X X X X X X X X X X X X X X X X C 168 X X X X X X X X X X X X X X X X X i

Includes subsections.

M - By Nordion only. s or 16 UNCONTROLLED CQFXug NOT FOR GENERAL USE

'ISAS 0010 C000 i

3-2 Ccde Requirements Handling of all materials used in scaled source fabrication shall be such that any scratching, denting, or jThis specification shall be subject to the CSA Standard marking of any kind is minimized.

CAN3-Z299.3-85 issue, and the following three system

functions from CSA CAN3-Z299.2-85:

3-5 Manufacturing Requirements 4 I (1) Handling and Storing ^ 3-5-1 Manufacturing Control Plan-A Manufacturing (2) Production Control Plan and special process procedures shall be prepared by the Vendor according to the requirements (3) Corrective Action f CSA Z299.2-85 and this specifi ation. Two copies of the special process procedures shall be submitted to the i Purchaser at least three weeks prior to manufacture for ,3-3 M:nufacturing Drawings approval. One approved copy of each will be retumed to the Vendor * ,The dr: wings listed in the contract documents are ~ ference design and manufacturing drawings. The re 3-5-2 Inactive Weiding-The Vendor shall submit a jVendor may make tus own workshop drawings. Such detailed welding procedure for approval by the drawings shall be submitted for approval by the Purchi.ser,3 weeks prior to the start of that component's Purchaser at least 3 weeks prior to begmning production. manufacture. Approval by the Purchaser of Vendor's Welding electrodes, flux, and other materials to be used shop drtwings shall not relieve the Vendor from shall be certified to applicable specifications. responsibility for any errors or omissions therem. Welders, who shall perform welding for this contract @-4 St: rage and Handling of Materials and must submit their qualifications for approval. Ccmponents Production welds require a minimum of 80% , Materials and components used in the construction and penetration. Figure 1 illustrates the correct methods for essembly of the capsule shall be as specified on the measunng the penetration requirements for side & end hpplicable drawings. If the materials or the components welds. The Vendor should demonstrate, by in-process are to be substituted, then the substitution must be control, that he meets this requirement. In the absence of ' subject to approval by the Purchaser. Where proprietary in-process control, the Vendor shall make a test weld on " parts or materials are specified, it is the Vendor's a dummy capsule by each individual welder at the start responsibility to ensure that they conform to the of each production run and once for every subsequent et:tndtrds given in the manufacturer's specifications. 25 capsules processed. For those components and assemblies required to meet The test sample (s) shall be inspected according to ,the quality verification requirements of CSA Z299.2-85: Section 4-4, " Macro Examination of Welds". 1 i) Certification of materials by the Vendor is Cleaning of stainless steel parts shall be in accordance i required in the form of Certified Material Test with the recommendations and precautions of ASTM Reports (CMTR's), Mill Certificates, or A380. 1 Cutificates of Compliance. his documentation shall be included in the History File described 3-5-3 Active Welding-Active welding will be in Section 4-8 of this specification. performed by Nordion. The general requirements described in Section 3-5-2 (above) also apply to active

11) Storage and handling of all materials and welding.

processed subassemblies shall be carried out in a manner that ensures their positive Specific active welding requirements are listed in identification during manufacture and Appendix C. he appropriate specification is indicated assembly. De requirements of section 3.5.12 of on the drawing and must be strictly adhered to. CSA Z299.2-85 shall apply. MyM i $~:@ UNCONTROLLED COPY' j OCMER 2 NOT FOR GENERAL USE I

9 9 a M*4'A 4 A J ^ r 5/TS 0010 C000 p rA % Weld Penetration = Tw x 100 Tt Where Tw = Distance to intersection of weld penetration & material joint Tt = Capsule wall thickness a o if jP r v i Tt Tw d-n .i CIRCUMFERENTIAL WELDS i k '* Tw END WELDS a Acceptable r""""""/ "' n M s i L J///////////s//F V Unacceptable g Figure 1 Weld Penetration 7of16 UNCONTROLLED CORXug NOT FOR GENERAL USE

IS/IS 0010 C000 j l 3-5-4 Fitting and Machining-The dimensions, All scale, oxide, weld spatter, oil, chips, and other tolerances, and surface finishes called for on the foreign material shall be completely removed from all applicable drawings shall be met. Any discrepancies in exposed parts. All surfaces that cannot be cleaned after requiremcnts shall be reported to the Purchaser assembly shall be cleaned of all foreign material immediately. (including temporary rust protective coatings) prior to assembly. For side welded capsules, the base capsule and cap capsule end faces must mate properly with no visible Stainless steel parts shall be processed and handled in gap between the end faces. such a way as to minimize contamination by iron, grit, lead, halogens, and sulphur. Only clean stainless steel 3-5-5 Tooling--Any tooling manufactured by the brushes, and iron-free grinding wheels shall be used on Vendor shall be manufactured in accordance to this stainless steel surfaces. Only clean, sharp silica sand specification. shall be used for grit blasting. Shot peening or blasting is not permitted. All measuring gauges and/or special tooling used to - ' verify or preset dimensions shall be checked according 3-5-9 Cleaning, Packing, Storage l to the CSA Quality Verification requirements described & Shipping-Upon completion all parts shall be in Section 3 2. cleaned. Stainless steel components shall be cleaned according to ASTM A380, section 8. Two copies of the Sources or capsules manufactured with new tooling Vendor's cleaning procedures shall be submitted for shall be tested and inspected according to Section 4-6. approval to the Purchaser at least 3 weeks prior to Production using new tooling may only begm once the manufacture. tooling has been approved by the Purchaser and up-to-date tooling drawings have been submitted to the All components shall be individually wrapped and Purchtser. placed in packages that identify the capsule type and serial numbers. They shall be stored in such a manner j Tooling drawings shall be re-submitted to the Purchaser that they will not become distorted or damaged during if the tooling has been modified, re-designed, or at the transit. All components shall be handled in accordance Purchaser's request. with the procedures described in Section 3-4. 3-5-6 Heat Treating-The C-337, C-340, C-343, If components are to be stored for an extended period, C-359, C-361, C-369, and C-990 capsules all contain parts they shall be stored in a dry, clean area. that require special heat treatment to obtain a specific hardness, grain structure, and phase composition. The heat tretting procedure and the raw material stock size 4 INSPECTION, TESTS, AND are specified on the drawing. His procedure will give DOCUMENTATION tha required material properties for the specified stock material. The Vendor shall provide all testing and inspection services and facilities except where otherwise specified. The Vendor may propose an altemative material size The inspection work shall be under the control of a and/or heat treating pweedure. Such altematives must competent chief inspector, whose prime responsibility is be submitted to the Purchaser for approval at least 3 inspection, and who is independent of production. Weeks prior to the start of manufacture. 1 ne Vendor shall prepare a detailed Inspection and Test 3-5 7 Crimping-Crimping shall only be done with Plan including Inspection Check Sheets and Inspection Purchaser approved tooling (Section 3-5-5) and Procedures according to the requirements of in-process control production procedures. CSA Z299.3 - 85 and this specification. Production crimping shallbe inspected according to - Two copies of the Inspection and Test Plan including Section 4-5. Inspection Check Sheets and Inspection Procedures shall be submitted to the Purchaser at least three weeks prior 3-5 8 Surface Finish and Cleanlinese-All welded to manufacture for approvat One approved copy of - surfaces shall be smooth and shall merge smoothly into -

each willbe returned to the Vendor.

b the p: rent metal. All gouges, scratches, or other marks. shall be removed. ,4 a 1'6 N 93 AUg'

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NOT FOR GENERAi. USE AA a m

IS/T30010 C000 (' Inspection by the Purchaser or his authorized Compliance. This documentation shall be included in representative shall not in any way relieve the Vendor of the History File described in Section 4-8 of this any of the inspection duties called for herein. specification. If deemed necessary, the Purchaser shall have the right 4-3-2 Purchased Mechanical Components-All to specify additional inspection or testing. Such purchased components shall be as specified on the inspection and testing shall be at the expense of the engineering drawings. Proof shall be in the form of Purchaser. permanent markings (such a* model or part numbers) or Certificates of Compliance by the supplier. The Vendor shall maintain :ecords of allinspections and tests that shall be available for review by the Purchaser 4-4 Macro Examination of Welds or his authonzed representatwe. This method of examination is used for rapid in all cases the following are minimum requirements. determination of test weld penetration for stainless steel The Purchaser will consider altemate methodologies, capsules. The sectioning and examination procedures for such as the use of statistical process control which the C-324 titanium capsule are described in Nordion provides greater assurance of control. Procedure IS/OP 0068 C324. 4-1 Non-Conformance and Corrective 4-4-1 Sectioning-Care should be taken to avoid Action excessive heat generation during cutting operations. If any part, component or assembly fails to meet an 4-4-2 Finishing-Stainless steel samples shall be inspectior. or test requirement specit;ed herein, the sectioned with a saw and then wet ground to a surface Vendor shall notify the Purchaser. Tlw Vendor must achieved with a 600 grit silicon carbide abrasive to obtain written permission from the Pur.haser before any remove all saw marks. remedial action is taken. 4-4 3 Etching-Stainless steel samples shall be if remedial action, including associated redesign,is immersed in a solution of aqua regia (1 volume of HNO3 likely to affect the results of tests or work previously to 3 volumes of hcl). completed, appropriate reinspection and testing shall be carried out. The repair, the rework, and the Quality Samples shall be observed during the process of etching Control procedures necessary to ensure a satisfactory (approximately 2 to 3 minutes). As soon as the weld repair shall be subject to approval by the Purchaser. geometry becomes visible, the samples are removed from the solution and thoroughly rinsed with water. Full documentation of any of the above shall be maintained so that non-conformance can be evaluated 4-4-4 Requirements-A weld is acceptableif the and corrected, following requirements are met (Figure 1): (i) Prototype capsules: a minimum of 100% weld gg g penetration. At the request of the Purchaser, the Vendor shalj Production capsules: a minimum of 80% weld reinspect any component or material. Any defects so Penetration. revealed shall be cause for rejection of the component, or attematively, for corrective action and subsequent (ii) General weld appearance is satisfactory. reinspection. All costs of reinspection shall be bome by the Vendor; however if no unacceptable defects are 4-5 Tensile Crimp Testing - Production revealed, reinspection requested by the Purchaser shall be at the Purchaser's expense. All crimp connections on the sources listed in Table 2 shall be tensile tested according to the procedures described in the following sections. The Vendor shall 4-3 Materials and Component inspection provide the Purchaser with a record of the results of all 4-3-1 Raw Materials-Certification of materials by the Vendor is required in the form of Certified Material Test Reports (CMTR's), Mill Certificates, or Certificates of 90f16 UNCONTROLLED CQpLg NOT FOR GENERAL USE

IS/TS 0010 C000 (2) Fix the source end of the source capsule Table 2 assembly and attach a pull device to the portion Pull Testad Sources of the assembly (connector end or locking ball) that did not previously fail. Apply an Capsula No. Desen,ption or Use increasing tensile load until failure occurs. Record the load and location of failure. C-192 Radiography Capsule for Sarnia (3) Similarly pull test the capsule source end to Inspection cable crimp and record the failure load. C-245 Radiography Capsule Assembly Should any capsule connector end, locking ball, or h s urce end fail at less than 270 lb (Table 3), the XC-266 RadiograP yCaPsuleforSinco Supply Production run shall not proceed until the cause of failure has been determined and the source capsule has C-337 For Tech. Ops. Camera #660 met the minimum (270 lb) pull test regturements. i Source Assembly Table 3 Crimp Failure Loads C-340 For Budd 520 Camera Source Assembly l C-343 For Spec 2-T Camera Source Assembly Locking Ball 2 270lbf C-359 For Gamma Century SA & Connector 2 270 lbg 35-SA Camera Source Assembly C-361 For Tech-Ops #533 Camera Source Assembly For purposes of crimped connection testing, a production run consistr of the crimping of identical C-369 For Nuclear Iberica NI-202 parts. More than one capsule type can be involved. Camera Source Assembly Vendor supplied assemblies may be tested using an C-990 For Nordion Titan Camera Source Assembly 4-6 First-Off Testing & Inspection Before regular production can begin using new tooling, rst&pection mus& pedonned Wordoa A a

4 5-1 In Process Testing-The following tests shall be minimum f five SamP es must be manufactured using l

. performed on the crimped connections for each the new tooling and submitted to the Purchaser for - product. ion run.Three capsule assemblies shallbe pull approval. Upon approval, regular production may begin. tested to failure: the first, last and one selected at i random from each production run (i.e. three (3) in total A first-off inspection is also required: per run). (i) if tmlingis redesigned or modified (1) Fix the connector end of the source capsule 4 assembly and attach a pull device to the locking (i) at the Purchaser's request ball. Apply an increasing tensile load until fillure occurs. Record the load and location of (iii) if the manufacturmg procedures are changed. failure. UNCONTROLLED COPY gg NOT FOR GFNFRAI IIRF

? ' [.', ' 5/150010 C000 s ) 1 ? 1 > DRIVE CABLE CONNECTOR l l D J 1 F CONNECTOR END J LOCKING BALL NOT E: Locking Ball may be part of the connector s 7 > SOURCE END J Figure 2 Typical Pull Tested Source 11 of 16 UNCONTROLLED COFXug NOT FOR GENERAL USE

. -. -. - - - -. - - ~. l 5S/15 0010 C000

4-7 H: rdness Testing 3.

Q.A. Release Form No. QAP-SF-06.1A, (1 fordion International Inc. Quality Assurance 311 hardness testing as specified on the drawings, shall Moual) for product.

performed in accordance to ASTM E18. Testing shall j 3e performed on the unmachined bar stock of the 4.

Copies of Purchase Order and all amendments q ippropriate diameter, as specified on the part drawing if applicable. i naterial specification. Equipment and procedures shall De in accordance to the above specification. 5. List of approved Special Process Procedures, Inspection Procedures, and Inspection and Test } For convzrsion, the procedures described in ASTM Plan including Inspection Check Sheets. 3140, " Standard Hardness Conversion Tables for i hietals", shallbe used. 6. Completed Inspection and Test Check Sheets and Reports. j 4-8 Documentation 7. List of Drawings and Specifications with The Vend:r shall prepare and maintain records that current revisions in effect at the time of j ? shill be cvailable to the Purchaser during the period of manufacture, and the serial number of the j l manufactum. 'Ihese shall be compiled, as the work capsules manufactured. ! Proceeds, into a bound 8%" x 11" (or the equivalent SI

metric size) History File that shall be tumed over to the 8.

Copies of all original Deviation Disposition

Purchaser with the Quality Assurance Release Form for Requests (DDR's) signed by the Purchaser's eich bitch run of items. The run components shall be Engineering Dept.on Nordion Form

' kept segregated until the Quality Assurance Release QAP-SF-14. Formis recepted by the Purchaser. 9. Certified Material Test Reports (CMTR's), Mill ! The History file is to contain the following: Certificates, or Certificates of Compliance, ,) certifying all materials used are as specified. 1. Table of Contents.

10. Certified NDE reports, leak test reports, etc.

2. History File release or transmittal. and personnel qualifications where applicable.

11. Any other documents requested by the Purchaser in the contract documents.

4 a i i 1 l i p

tvr% chD

'~ UNCONTROLLED COPY 1.A>uam JdCM NOT FOR GENER AL llSE

o IS/TS 0010 C000 p APPENDIX Av Applicable Capsules and Drawings: Capsule Type ; - Description Engraving Assembly Detail Drawing ID Drawing C-324 I-125 Source (Ti) AD K121004003 K121010006, K121010007 i Type 1 C-324 I-125 Source (Ti) AE K121004004 K121010008,K121010009 Type 2 C-265 X-Ray Fluorescence AC A12355 A12356, A12357 C-181 Radiography Capsule Ass'y BA A05800 A05796, A05797, A05798, A05799 C-192 Radiography Capsule for Sarnia insp. BB A07120 A07121, A07736, A03334 i C-204 Radiography Capsule BC A02029 A02030, A02031, A17720 XC-234 Radiography Capsule for Consumers BD A07516 A07517, A07518, A07519, A10304, A17720 C-245 Radiography Capsule (Budd) BE A09425 A03334, A07736, A17720, i A09403, A09266, A09268, ~ A11354, A11355, A11356, A11357 4 XC-266 Radiography Source Capsule for Sinco BF A12671 A12670, A03334, A07736 C-337 Iridium 192 Cable Source Assembly BG A16827 A16828, A16829, A16846, A03334, A03335, A17720 C-340 Iridium-192 Cable Source Assembly BH A16833 A17714, A17716, A17720, A03334, A03335, A16829, A16849 C 343 Iridium-192 Cable Source Assembly BI A17715 A17714, A17717, A17720, A16829, A16849, A03334, A03335 C-349 Iridium-192 Capsule Ass'y BJ A18351 A18353, K113217027, K113217035 C-352 Iridium-192 Capsule Ass'y BK A18388 A16637, A16640, A17720, A18351 13 of 16 UNCONTROLLED CO8bg NOT FOR GENERAL USE

15/150010 C000 APPENDIX A Applicable Capsules and Drawings (Cont'd) CCpsule Type Description Engraving Assembly Detail Drawing ID Drawing C-164 SRC-3 Radiography Capsule Ir-192 BL A05488 SRC-3 Radiography Capsule Co-60 CA A05488 SRC-3 Radiography Capsule Sb-124 DA A05488 TC-346 Bulk Iridium Shipping Capsule BM A17724 A17722, A17723 C-357 Iridium-192 Stand-Alone BN K1121104001 K121110001, A03335 Source Capsule C-359 Iridium-192 Cable BO K121104002 K121113001, A17714, Soutre Assembly A16829, A03334, A17720, A16849 C-361 Iridium-192 Cable BP K121104003 K121113002, A17714, Source Assembly A03334, A03335, A16829, A17720, A16849 C-369 Iridium-1L Cable BQ K121104004 A03334, A03335, A17720 Source Assembly ) C-990 Iridium-192 Cable Source Assembly C990 K122213600 A17714, K122213-601, A16829, A03334, A03335, A16849, K122213-602, A17720 C-140 Cobalt-60 Radiography CD A05519 A05520, A05525, A05526, Source (Type 1 to 5) A05527 A05532 A05528, A05529, A05530, (Type 5 Only) A05531, A05533, A05534 C-163 Cobalt-60 Radiography Source CC A05663 C-168 Cobalt-60 Radiography Source CD A04141 A04142,04143 O NEG 0 21 dM UNCONTROLLED COPY" ' " OJ EN*U*' - NOT FOR GFNPRAL USE A

av ~ t, ,- a ~" '^" ~^ ~ .e4 y 'C. IS/15 0010 C000-. O APPENDlX B L. Appllcatile Standards ASTM Volumes 01.01, 01.03,01.04,01.05,02.04, 03.01,03.03,03.05 (As Applicable) CSA Bl.1 Unified Screw Threads CSA B95 Surface Texture CGSB-484P-9 Certification of Non-destructive Testing Personnel CSA CAN3-Z299.2-85 Quality Assurance Program - Category 2 CSA CAN3-Z299.3-85 Quality Assurance Program-Category 3 ASME BPV American Society of SectionIX Mechanical Engineers, BPV Code SectionIX: Welding and Brazing Qualifications ) ASME BPV American Society of Section Il Mechanical Engineers, BPV Code Section II: Material Specifications ANSI Standard RadiologicalSafety for the N432 Design and Construction of Apparatus for Gamma Radiography ANSI Standa'rd Scaled Radioactive Sources, N542 Classification ISO 2919 Scaled Radioactive Sources-Classification 15of16 UNCONTROLLED CQPXug NOT FOR GENERAL USE

IS/150010 C000 s APPENDIX C Applicable Nordion Specifications and Procedures Nordion Spec. No. Title l DG 0042 A000 Scaled Source Fabrication (Short Term Warranty) 3 i DG 0043 2000 Micro examination of Welds DG 0044 G000 Macro examination of Welds DG 0046 C000 Internal Air PressureTest DG 0048 2000 Dye Penetrant Test DG 0052 C000 Vacuum Liquid Bubble Test J IS/OP 0040 C000 Procedure for Engraving Radioactive Source Capsules Nordi:n Spec. No. Title DG 0050 C000 Hot Liquid Bubble Test DG 006S G000 Dry Wipe Test DG 0148 C000 Ultrasonic Decontanunation ') Procedure (Iow Output Sources) IS/OP 0031 Z000 Procedure to Check Ultrasonic Tank Operations IS/OP 0034 2000 Charcoal Adsorption Leak Test IS/OP 0068 C324 Operating Procedure for Sectioning and Examming C-324 Capsule welds. 1 v 3 N h j,,,m. Uil'd NTROLLED COPY -'r ; g aa mnr nnneuen,,ing

1 TR-9412-C990 (A) l ) l l l 1 ) i l i 4 l l 1 Appendix 3. Nordion Specification IS/DS 0055 N990(B) 1 l l 1 a I .I 8 EC 1994 s 5 4." ? i, 2 ^ - s}, 7 f.1,* 7 q y 4.,9 3,is, yn, 'k'.'.? sp, ,g, -.a s 4

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i 447 March Road, P.O. Box 1350u, Kanata. Ontario, Canada. K2K 1X8 j Tel:(613) 592-2790, Telex:(053) 4162 Telefax (613) 592-6937 TIONAL INC. i DESIGN SPECIFICATION i Test Plan for the Titan Gamma IS/DS 0055 N990 (REV B) j Radiography Exposure Device CURRENT DATE: 93 MAY b DATE ISSUE COMMENTS /AFFECTEDPAGE PREPARED BY REVIEWED BY APPROVED BY 92 Feb 0 Original issue B.Menna M. Krzaniak/ G. Def alco G. Burbidge l f 93 Jan A General Revisions B.Menna R. Goddard / G. Defalco M. Krzaniak/ G. Burbidge 93 May B DC 90571 B.Monna M. Krzaniak G. Burbidge Afb b

Ybn-ruh g

This document contains information proprietary to Nordion Internationaline. Any disclosure or use of this information or any reproduction of this document other than the specified purpose for which it is intended is expressly prohibited except as Nordion International Inc. may otherwise agree in writing. NOTE: The portion of this text affected by the changes is indicated by a vertical line in the margins of the pages. [ IS0055B1 UNCONTROLLED COPY Mnr eno neucoai iice

Table of Contents j 1 INTRODUCI1ON....................... 3 2 CLASSIFICATION .3 3 PROJECT REQUIREMEN'IS................. 3 4 TEST REQUIREMENTS.................... 3 5 DEFINITIONS......................... 3 6 QUALITY ASSURANCE REQUIREMENTS.... .6 6-1 Independent Testing................... 6 6-2 Sul> Contractor's Quality Assurance.......... 6 6-3 Calibration......................... 6 -7 PROTOTYPE TESTING,................... 6 7-1 Tests OnThe Entim Apparatus............. 6 7-1-1 Projection Under StressTest.......... 6 7-1-2 Endurance Test.................. 8 7-2 Tests On The Exposure Device............ 10 7-2-1 Radiation Shielding Test........... 10 7-2-2 Vibration Test................. 12 7-2-3 Horizontal Shock Test............. 12 7-2-4 VerticalShock Test 14 7-2-5 Handle Wrench Test.............. 15 7-24 Water Spray Test................ 16 7-2-7 Immersion Test................16 7-2 8, Free Drop Test................. 16 7-2-9 Stacking Test.................. 16 7-2-10 Penetration Test................ 17 7-211 Puncture Resistance Test........... 17 7-212 Accidental Drop Test............. 18 7-2-13 Mm Test..................... 19 7-3 Tests On'Ihe Remote Control Device......... 19 7-3-1 Kinking Test.................. 19 7-3-2 Crushhg Test.................20 7-3-3 Tensile Test................... 21 7 4 Tests OnThe Pmjection Sheath............ 22 74-1 Kinking Test.................. 22 74-2 CrushingTest.................23 7-4-3 Tensile Test................... 24 7'-5 Tests On'Ihe Source Assembly............ 24 7-5-1 Tensile Test................... 24 8 REFERENCES.... ',................... 25 ' Appendix A-TestDataSheets ? Appendix B - Special Form Radioactive MaterialTestSummap i - + L , e l4i ( '* h f j - 'k J. ~I l + .w i UNCONTROLLED COPY j J' - ,J4 c %.o g+_

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_ w.aa,se+" NOT FOR GENERAL USE G

DESIGN SPECIFICATION IS/DS 0055 N990 (REV B) 1 lNTRODUCTION Exposure Device A shielded device employing a sealed source designed This document describes the detailed test plan for the to allow the controlled use of gamma radiation for the Nordion Titan Gamma Radiography Exposure Device (GRED). The tests are required to demonstrate that the Purpose of making a radiographic exposure. Titan meets the regulations for the design of gamma radiation exposure devices and the regulations for the GRED safe transport of radioactive material (references 1,3,4, 6,7). A description of the tests and detailed test Gamma Radiography Exposure Device. This term precedures areincluded. typically refers only to the exposure device, and not to the entire apparatus. 2 CLASSIFICATION locked Position The Titan GRED is classified under ANSI N432(1980) as Cor dition of the exposure device when it is locked (with a Class P, Type 1, Type R exposure device. The testing a k y) in addition to being in the secured position. described herein demonstrates that the device meets the requirements of this specification for a device of this Projection Sheath type. Additional testing willbe performed in order to support the design and to demonstrate that the Titan A flexible trhe for guiding the control cable and the meets the transportation requirements for Type B(U) attached sourca assembly from the exposure device to tr:nsport packaging (reference 6,7). the working pcsition. Also known as a source guide tube. 3 PROJECT REQUIREMENTS Quality Assurance Representative Tha guidelines for design, inspection and testing within A representative designated by Nordion's Quality ANSI N432(1980) and ISO 9000(1987) will be followed Assurance Department whose responsibility is to verify throughout the project. Some requirements of the that the testing has been conducted in accordance with revised ANSI standard, ANSI N43.9(1991) have been the quality assurance requirements and that the test adopted. results are thoroughly recorded and are accurate. Rein te controtDwice 4 TEST REQUIREMENTS A device enabling the sealed source to be moved to an Reference documents 1,3,4,6 and 7 outline in detail the exposing position by operation at a distance away from test requirements for gamma radiography equipment the exposure device. The remote control device includes and transport packagings. Table 1 summarizes these the crank mecharusm, control cable and sheath. The test requirements. Detait of the requirements are listed remote control sheath consists of a reserve side and a in section 7 of this test plan. Figure 1 illustrates the projection side (see Figure 12 for illustration). sequ:nce and flow of these tests. Secured Position The C990 source assembly has been demonstrated to ! meet Special Form requirements and has been classified Condition of the exposure device when the source as C43515 according to ANSI N543(1977)(see Appendix, assembly is fully shielded and restricted from j B); movement. 1 Swrce Assembly 5 DEFINITIONS A complete assembly including a sealed source, a short Many documents govern the testing to be performed on length (150 mm) of cable, a locking ball and an end ] the Titan. 'Ihey use many terms which are sometimes connector. The source assembly used in the Titan is ' interchangeable or which may have subtle differences in ' called the C990" (ref. drawing K12223-600 Rev. D). mianing'. For the purposes of this Test Plan, the c following definitions shall apply. 3NA%i $ UNCONTROLLED (W [Mj$ ,~ M fiO. D 04ld.M di;bddL NOT FOR GEN F A AL. USE a-

. =. _. l DES:3N SPECIFICATION IS/DS 0053 N990 (REV B) Table 1 - Governing Specifications and Their Tests Standard or Specification Device Nordion ANSI ANSI 10CFR 34 10CFR 71 Under IS/DS N432 N43.9 (Radiography) (Transport) 3999 n* Test Test 0055 (1980) (1991) see note 1 see note 2 Entire Projection Under Stress 1 X W us Endurance 20.000 20,000 50.000 50,000 Radiation ',hielding X X X X X X Vibration see note 3 / / X HorizontalShock X VerticalShock X X X X Handle Wrench X X X Lock Breaking Exposure Water Spray see note 3 X X DeWee Irnmersion see note 3 X X Penetration X X X Puncture Resistance X X X X X X Acx:Idental Drop X X X X X X Fire X X X X X Corrosion see note 3 X Free drop Test see note 3 Stacking Text see note 3 X Kinking X X X X 9, Control Crushing X X X X Device Tenslie X X X X Kinking X X X X Projection Crushing X X X X Sheath Tenslie X X X X Tightness X Source Tensile - Assembly X X X X Notes:

1) 10CFR 34 requires all of the tests from ANSI N432 (1980) in addition to those indicated.

2) 10CFR71 includes the following tests that will not be perfonned: Heat, cold, reduced. external pressure, increased external pressure and compression.

Jest will not be perfuiu.ed, but device is qualified by discussion. .,'[', i 1 d v 1 t 93 MAY ' f/F%h,TCidT" 4 of 25 'W i.. UNCONTROLLED COPY ehdbisdkb. idikb NOT FOR GENERAL USE

O 5 $5z m m On f' - d Tf * *${ L Q at ne e FTA:;, jl };; e .v v: I s

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EJ - Vibradon Hortaontal Vertlost Handle Penetradon Pariatinrt _p 4 Test Shodt Test Shock Test Wrench That Test Shieldin0 Test p; di r., 4 Remoto Remote Remote Control Coritrel Controi 4 Tenene Test Kinidno Test CrushhD Test Q g Radledon _y Strees Test % Test Stress Test Prokction Propcoon e .a Shesih Shese Sheath Kinidng Test Quahing Test l> Tensee Test m. Source AseemtM Tenses Test l: Source p.,ilarian Puncture Accidental Radiation Erdmance 4 % Test + Test Shielding Test Realstenos Test Deep Test Shieksng Test l T Z! C. oaz- -U o '- mio oz g 3 -4 6 a3 m O o mZ F 8 E msO Figure 1 z '- O Test Flow Chart C Q 3 (o up m m -t _tD

DESIGN SPECIFICATION IS/DS 00s3 N990 (REV B) QUALITY ASSURANCE 7 PROTOTYPE TESTING ^ REQUIREMENTS l The Nordion Titan project is managed ir. accordance with Nordion Specification IS/QP-0052-N990 and ISO 7-1 -1 Projection Under Stress Test 9000(1987). Testing will be performed in accordance with IS/QP-0052-N990. 7-1-1-1 Purpose 6-1 Independent Testing The purpose of this test is to measure whether the torque required to drive and retract the Where testing is performed by an organization source through a complete exposure cycle independent of Nordion International, the testing and changes during a lifetime of normal use. This results will be documented by this independent test is not a mquirement of ANSI N432(1980). It orgsnization. Where testing is performed by Nordion is performed to verify the design and is based Intemational, it will be thoroughly documented by the on the Projection Under Stmss Test from ANSI test engineer using sketches, photographs, video tapes N43.9(1991). and the Data Sheets in Appendix A. All test results will be validated by the project engineer. The testing will be 7-1-12 Equipment witnessed by a Quality Control Representative where appropriate. The entire GRED apparatus shall be tested. Before the final test it will have been subjected Representatives from the Canadian Atomic Energy to a variety of tests (see Figure 1). A torque Control Board will be invited to witness all testing. meter Snap On modelTBS2FUA willbe employed. A-2 Sub-Contractor's Quality Assurance 71-1-3 Location dub-contractors must have a quality assurance system in The testing will be performed at Nordion accordance with ISO 9003 or CSA Z2993. Quality International,Kanata, Ontario, system requirements include a quality policy, a quality system organization, quality records, a calibration 7-1-14 Approach system and personnel training. Sub-contractors will be evaluated on systems, procedures, and ability, prior t The testing will be performed in two stages. thestartof testing. Initial torque readings will be made on the new GRED equipment. Hen,after a series of tests 6-3 Calibration-on the

dividual components, the Equipment used for measdring test results shall be calibrated at the time of the test. He equipment ne final torque measurements willbe calibration due date shall be recorded on the data sheets.

performed on equipment that has been subjected to the following tests: Calibration shall be performed by a qualified laboratory. exposure device : horizontal shock, vertical e j shock, handle wrench and penetration remote control device : kinking, crushing, e tensile projection sheaths : kinking, crushing, tensile e souwe assembly: tensile e ne test setupis shownin Figum 2.,The bending radii for the mmote control and projection sheath willbe 500 mm. dr N M"sof 25 U$CbNTROLt. D COPY os uAy dE.CL.m NOT'FO'R"SENERAL USE

DESIGN SPECIFICAT10N IS/DS 0055 N990 (REV B) f l 2m gg # C r 2m 03 m P 45 4so n Y9 "/ N g / N l n 05m. 4 w 450 450 R - 0.5 m ~2m I Figure 2 GRED Apparatus Endurance Test Configuration ,iThthin31 - {7' f 2s;

-~

UNCONTROLLED CY' dilu%cGo, . mu.adiuL NOT FOR GENERAL USE - i

JESIGN SPECIFICATION IS/DS 0055 N990 (REV B) Ten exposure cycles will be performed during cycles, an exercise will be performed in order to which the maximum driving / retracting torque demonstrate that the source assembly will not will be recorded. disconnect when projected out of an open projection sheath. 7-11-5 Procedure 7-1-2-2 Equipment

1) Set up the GRED equipment in the configuration shown in Figure 2. The The automated endurance test equipment bending radii at comers shall be 500 mm for illustrated in Figure 3 will be used to perform the remote control and projection sheath.

the cycling. Impressions of the source tube will Connect the torque meter to the remote be made using Dow Coming Mold Making control crank mechanism. Compound DC HSII.

2) Drive the source assembly to its fully 7-12-3 Location extended position and then retract it fully.

Care must be exercised in order not to With the exception of the thermal cycling this measure the sharp rise in torque when the test shall be performed at Nordion International source reaches the end of its travel at each Inc., Kanata, Ontario. extreme. 7-1-2 4 Approach

3) Measure the driving torque and record the maximum value measured during the cycle.

The equipment will be subjected to continuous cycling for 20,000 cycles.

4) Repeat the process 10 times and record the data on the Projection Under Stress Test At the completion of 20,000 cycles,50 cycles will Data Sheet provided in Appendix A. Be be perforced with the end of the projection i

certain to fill out all of the information sheath open. During these exposures, the requested on the data sheet. The test source assembly will extend at least 1 meter out engineer must sign the data sheet and a of the projection sheath. This additional test is quality control representative must witness not a requirement of ANSI N432(1980). Rather the test setup and at least one cycle of the it is a requirement of ANSI N43.9(1991) that has testing. The test results must be validated been adopted to prove that the source assembly by the project engineer. will not accidentally disconnect or snag outside j the projection sheath.

5) Steps 1 to 5 are to be repeated once the equipment has been subjected to the tests At the conclusion of the test,100 cycles willbe for conditions of normal use listed in performed with the exposure device at -40 C, paragraph 7.1.1.4.

and an additional 100 cycles will be performed at +55 C. These cycles are not a requirement of 71-1-6 Data and Results ANSI N432(1980) and will be performed after the completion of the 50,000 cycles. The entire The test data shall be recorded on the form remote control and projection sheath need not provided in Appendix A. Allof the required be exposed to the temperature extremes and information must be completed. An increase in these peripherals may be shorter than those idrive torque of 25% or more shall constitute a used for the Endurance Test at ambient failure. temperature. 7-12 Endurance Test After having been subjected to the endurance test, the source assembly will undergo the 7-1-2-1 Purpose 1 Tensile Test of paragraph 7.5.1. ), ';The purpose of this test is to repeatedly operate the apparatus in order to determine its + M fesistance to fatigue, and to measure any wear y the equipment components. After 20,000 e -c INW%~ sor25' [ h f ~" UNCONTROLLED COPY,k j ddillEID.D dlM4 Mwd NOT FOR GENERAL USE b i

. ~. DESIGN SPECIFICATION IS/DS 0053 N990 (REV B) TITAN AUTOMATIC o[y O PROJECTION SHEATH EC { = e _~ a w [' % 1 REMOTE CONTROL SHEATH \\ MOTOR REMOTE CONTROL CRANK MECHANISM GEAR TOROUE REDUCER LIMITER l FLEX 1BLE COUPLING Figure 3 Endurance Test Setup .Jf . s. s >3 a if4?W. DDn,E_, I ' [,. ' ". ' UNCONTROLLED COFNrAY c: oct2s . 4 i LiaiwAMi.ma = ,.4?o lRu;4Av.NOT FOR GENERAL USE

. - =. l j DESIGN SPECIFICATION IS/DS 0055 N990 (REV B) l l The test setup is shown in Figures 2 and 3.

7) Once 20,000 cycles have been completed, the The automatic test apparatus shall meet the end of the projection sheath shall be opened following requirements:

to allow the source assembly to pass through. 50 cycles shall be performed i Minimum speeds : rotating 180 RPM during which the source assembly shall linear 0.75 m/s extend at least 1 m from the projection sheath. The torque that the apparatus exerts at each extreme

shall be determined by measuring the force experienced

8) At the completion of the testing, the

by the drive cable during manual operation. The test apparatus shallbe moved to an

! apparatus will then be adjusted accordingly. environmental test chamber where the equipment shall be subjected to 100 cycles at 7124 Procedure temperature of-40 C. The remote control device and projection sheath do not need to

1) Measure the length of the dummy source be entirely exposed to the temperature assembly. Record the measurements and extn-me, and these peripherals may be the source assembly serial number on the shorter than those used for the Endurance C990 Source Assembly Tensile Test Data Test at ambient temperature.

Sheet, as this length will be required for comparison at the completion of testing.

9) Repeat step 8 with the temperature Record the tolerance associated with the stabilized at +55 C.

length measurement and the calibration date of the instrument.

10) Remove the dummy source assembly. Tag and identify it, as a Tensile Test will be

2) Check thv.ntegrity of the source tube by performed on it as per paragraph 7.5.1.

taking an intemal impression using Dow ' Coming Mold Making Compound DC HSII.

11) Check the integrity of the source tube by taking an intemal impression using Dow

3) Connect the equipment under test as shown Coming Mold Making Compound DC HSII.

in Figures 2 and 3, 7-124 Data and Results

4) Start the automated test equipment and verify that the counters are working Any start up, shut down or maintenance action properly. Check that the source assembly is shall be recorded on the Endurance Test Log travelling from the secured position, to the Sheet. Photographs of any failures or fully extended position and back. Record maintenance actions are required. Failure the date, time and cycle number on the criterium shall be failure of the apparatus to Endurance Test Log Sheet in Appendix A.

remain completely operational after 20,000 Be certain to initial every entry on the Log cycles. Additionally, the integrity of the sealed Sheet. source and the encasement of the depleted uranium shielding must not be breached . 5) Regularly check the test apparatus for through wear after 20,000 cycles. An impression proper function or anyincidents. An of the inside of the source tube will be made incident includes test startup or shutdown, before and after the test.. failures or any other test anomalies. 7-2 Tests On The Exposure Device

6) Record any m.ctdents on an Endurance Test Log Sheet providedin Appendix A. The 7-2-1 Radiation Shielding Test; date and time of eachincident mustbe I

recorded and initialled. If the incident l resultsin the shutdown of the test 7-2-1-1 Purpose apparatus, it must be witnessed by a Quality ~ Assurance Representative before the, The purpose of this test is to, determine the. apparatus may be nestarted. Disposition exposure rate from the device to assure that the ~ must be givenby the pmject engmeer. ly. jfM pqp be ~ a.r.- o "'JJ F ' 3 { ((k SWE 2;36WsdRhLI.ED COPY U CONTNO g _aeams

w m r -

DESIGN SPECIMCATION IS/DS C355 N990 (REV B) dose rates in the vicinity of the device are within 7 21-3 Location the limits specified. The testing will be performed at Nordion 7-2-1-2 Equipment Intemational, Kanata, Ontario. The Radiation Shielding Test will be performed 7-2-1-4 Approach on new exposure devices prior to the commencement of any mechanical testing, after A detailed survey will be performed on the two the Penetration Test, after the Endurance Test, prototypes when they are new. Measurements and if possible, after the tests for accident will be made at every node on the grid system conditions. The measurements will be made on shown in Figure 4. In locations where the fields exposure devices with the end caps installed, are relatively high, the hot spots will be located and identified in relation to the grid system. The Victoreen Model 440 and Model 660 survey Radiation field measurements made after the meters will be used for measurements. exposure device has been subjected to testing Substitute survey meters may be used provided will not be as thorough. ney will be limited to that the meter used to measure the exposure rate areas of the device which have been affected or at 50 mm from the surface does not average over damaged by the testing. 2 an area greater than 10 cm and has a sensitive volume with no linear dimension greater than A sample source is to be used for the 5 cm. He meter used to measure the exposure measurement and the exposure rate is to be rate at 1 m from the surface must average over extrapolated to the maximum rating of 4.44 TBq 2 an area no greater than 100 cm and its sensitive (120 Ci) for the device. The extrapolation is not volume must have no linear dimension greater to exceed a factor of 10, but the source should than 20 cm. approach an activity of 4.44 TBq (120 Ci) as safely and as practically as possible. 1 2 3 4 83 14 15 15 E 5 e 7 6 R [ 17 18 19 20 M u U u U o 10 11 12 21 22 21 24 fo o 1 i n JCJ t 'M 39s 37 j 26 26 27 28 } 29 in 31 32 40 41 42 O $ 4s k c m u m u 4 -m9 a } f sik 63

'0 l

\\ u a a a u a u krm J Figure 4 Radiation Survey Grid System ~ _11 of 25 UNCONTROLLED 6GDW i s.m. d-NOT FOR GFNFR AI IISF

- ~. - - = DESIGN SPECIFICATION IS/DS 0055 N990 (REV B) i The maximum specified dose rates are as device, and calibration data for the test follows: equipment. Complete all of the calculations { on the Radiation Shielding Test Data Sheet. e 2 mSv/hr(200 mrem /h)on surface e 0.5 mSv/hr (50 mrem /h) at 50 mm from the 7 2-14 Data and Results surface e 0.02 mSv/hr(2 mrem /h)at 1 m from the The measured field for the source and the surface activity calculation shall be shown on the Radiation Shielding Test Data Sheet. The The activity of the source will be determined extra #adon calculation shall also be recorded based on 0.55R/h-Ci at im for Ir-192. n the data sheet. If it is not possible to load a source assembly Fields in excess of the following constitute a into the device after the tests for accident I*II" conditions, then a radiation shielding analysis 2 mSv/hr(200 mrem /h)on surface e will be performed to determine the exposure 0.5 mSv/hr (50 mrem /h) at 50 mm from the rate at this time. e surface 7 21-5 Procedure 0.02 mSv/hr (2 mrem /h)at 1 m from the surface

1) Measure the fields from the sample source and record the fic!d output at im on the 7-2-2 Vibration Test Radiatien Shielding Test Data Sheet.

2) Observing the required safety procedures, install the sample source in the exposure The purpose of this test is to determine the device.

resistance to the exposure device to the vibration that it may encounter during normal

3) Using the Victoreen Model471 Survey service. This test is not a requirement of ANSI Meter, measure the fields 50 mm from the N432(1980).

surfaceof theexposuredeviceateachof the nodes identified on the 3 inch grid system in 7-2 2-2 Discussion Figure 4. Allow the meter reading to stabilize for 5 seconds at each node before The vibration test is intended to reveal any recording the measurement. Record each environmental effects that may occur during measuremerJ on the Radiation Survey Data normal service. Examples of such effects include Sheet, and record the maximum reading on loosening of fasteners, component fatigue, the Radiation Shielding Tect Data Sheet. chafing between parts and cracking or rupturing of structural members. The Titan is a welded

4) Measure the fields at 1 m from each of the 6 structure, and any threaded fasteners are fixed faces of the exposure device. Record the

,ith thread sealant. Additionally, the enclosure measurements on the R'diation Survey .njected with an epoxy foam which fills all Data Sheet,and record the maximum internal voids. The Titan is therefore not reading on the Radiation Shielding Test susceptible to the environmental effects causet Data Sheet. by vibration and there is no need to perform the vibration test.

5) After the initial Radiation Shielding Survey on the exposure device, it is only necessary 7 2-3 Horizontal Shock Test to make readings at locations on the device that are likely to have been affected by the

' testing. 7-2-3-1 Purpose 6 i ) . 6) Reconi all of the data on the Data Sheets, "Ihe purpose of the Horizontal Shock Test is to test the resistance of the device to the shocks including the date, activity of the test that may be encountered during normal service. source, serial number of the exposure .x. . c.. .,c5 83 %xQ Ogggggi 12of255 }{

y-UNCONTROLLED COPY ~

ahunh _dL:.uc unrgnnnyugnai mg-

DESIGN SPECIFICATION IS/D3 OO55 N990 (REV B) 7-2 3-2 Equipment sideof theexposuredevice a sideof thelock e The equipment used for the Horizontal Shock l face f thelock Test is shown in Figure 5. The exposure device e shall have been subjected to the Projection bottomof theexposuredevice o Under Stress Test of paragraph 7-1-1 prior to the side of pmjection sheath connector e Horizontal Shock Test. face of projection sheath connector e 7-2-3-3 Location 7-2 3-5 Procedure The testing will be performed at Nordion

1) Conr.ect the device under test to the l

International, Kanata, Ontario. suspension chain. Adjust the height and l 7 2 34 Approach orientation so that the device will strike the pin in the desired location. The Horizontal Shock Test consists of pendulum

2) Measure the height to the bottom of the swings of the device into a rigidly mounted cylindrical steel bar. 'Ihe exposure device will exposure device.

be suspended such that it Just touches the target

3) Swing the exposure device back until the when at rest. 'Ihe release position will be a point whem the center of gravity of the device is licight to the bottom of the device has 100 mm above its rest position. The steel bar increased by 100 mm.

will have a diameter of 50 mm and a length of

4) Release the exposure device and allow it to 300 mm. It will be mounted to a rigid object l

with a mass of at least 225 kg. 20 impacts will swing into the target. be performed on each of the following areas: l l Suspension Chain 7 l d so wn g 100 mrn N L i N y N n g N Massa 2as xs N a00 mm 9 i i .l. Figure 5 4 e Horizontal Shock Test 4. -4 N ^ Ub@b3jp -- jf[ j UNCONTROLLED CgptAY 13 f 25 dhd@MMg M h NOT FOR GFNFAAI IlAF )

DESIGN SPECIFICATION ISOS 0053 N990 (A2V B) l l l

5) Record any observations on the Horizontal 7-2-4 Vertical Shock Test Shock Test Data Sheet in Appendix A.

Video tapes and photographs are required. 7-2-4-1 Purpose l

6) Repeat steps 3 to 6 until the device has been The purpose of the Vertical Shock Test is to test subjected to 20 impacts in the same area.

the resistance of the device to the shocks that may be encountered during normal service.

7) Repeat step 1 to 6 until each of the areas listed in paragraph 7.2.3A has been tested.

7-2 4-2 Equipment

8) Connect the remote control and the The test equipment is shown in Figure 6. The l

projection sheath to the exposure device and exposure device shall have been subjected to the l perform 10 exposure cycles. This step may Horizontal Shock Test of paragraph 7.2.3. l be performed at the completion of the Penetration Test of paragraph 7.2.10 at the 7-2-4-3 Location discretion of the test engineer. The testing will be performed at Nordion 7-2 3-6 Data and Results International, Kanata, Ontario. The date of the testing and the observations . 7-2-4-4 Approach after each impact shall be recorded on the Horizontal Shock Test Data Sheet. Video tapes The vertical shock consists of a drop from a and photographs of each impact area shall be height of 150 mm in the normal carrying taken as a minimum. Failure criteria shall be position. The impact surface will consist of a failure of the device to complete 10 satisfactory rigid body with a mass greater than 225 kg - i exposure cycles or failure of the Radiation covered by 25 mm of plywod.100 shocks will Shielding Test. be performed. I t Release Mechanism j o O 26mm V PWood 150 mm h%11%%%%%%%N ^ / Mese2225 Kg / Figues 6 Vertical Shock Test 1

L!

'" UNDbNTRblLED COPY h -f E ^" 93 MAY 14of 25 LL+ MA.16A LNOTVOR GENER AI IIRF

, DESIGN SPECIFICATION IS/DS 0063 N990 (REV B) l l 7-2-4-5 Procedure 7 2-5 Handle Wrench Test

1) Attach the exposure device to the release 7-2 51 Purpose mechanism and verify that the height to the i

bottom of the exposure device is 150 mm. The purpose of this test is to demonstrate that the carrying handle is able to withstand the

2) Release the exposure device and allow it to wrenching force applied to it when the device is fall onto the target.

dropped while tethered to a security chain. 'lhis test is not a requirement of ANSI N432(1980). It

3) Record any observations. Video tapes and is a requirement of ANSI N43.9(1991) and has photographs are required.

been adopted because it is considered to be an

4) Repeat steps 1 to 3 until 100 shocks have been performed.

7-2-5 2 Equipment

5) Connect the remote contmland the The test equipment is shown in Figum 7. The projection sheath to the exposure device and exposure device shall have been' pcted to the perform 10 exposure cycles. This step may VerticalShock Test of paragrapi 24.

be performed at the completion of the Penetration Test of paragraph 7.2.10 at the 7 2-5-3 Location discretionof thetestengineer. The eating will be performed at Nordion 7-2-4 6 Data and Results International, Kanata, Ontario. The date of the testing and the observations 7 2-5 4 Approach after each impact shall be recorded. Video tapes 1 and photographs shall be taken. Failure criteria The device will be dropped 1 m while attached shall be failure of the device to complete 10 to a chain. The upper end of the chain will be l satisfactory exposure cycles or failure of the attached to a rigid mounting point. Radiation Shiciding Test. l /////////// W n \\ h e seauty chah l l l = l l a l l 1m (/\\3 \\ / ,g ) N*] \\ (_.) Figure 7 Handle Wrench Test ,[M ^15'af as UNCONTROLL'ED CSFWAY . A- ~. I;.,- NOT FOR GFNFRAI tlRF m.

DESIGN SPECIFICAYlON LS/DS 0053 N990 (REV B) 7 2-5-5 Procedure 7-2-7 Immersion Test

1) Fasten the safety chain to the handle of the 7-2-7-1 Purpose exposure device, ne purpose of this test is to verify that the

2) Suspend the exposure device so that it will exposure device will not suffer any damage drop 1 m when released. Make certain that when subjected to immersion in 15 m of water.

the exposure device will not reach the ground or strike any obstructions when it is 7-2-7-2 Discussion released. The primary purpose of the immersion Test is to

3) Release the exposure device and allow it to demonstrate that a package can maintain its l.

drop freely. structural integrity when subjected to an externalpressure. De Titan does not

4) Record any observations. Photographs and incorporate seals to prevent the influx of water, video tapes are required to support the nor am any of its components sensitive to water.

observations. ne source assembly has been demonstrated to meet Spedal Form requirements (Appendix B).

5) Connect the remote control and projection nerefore, the Titan would not suffer any l

sheath to the exposure device and perform damage if immersed in water and there is no 10 exposure cycles. Thisstep maybe need to perform theImmersion Test. performed at the completion of the Penetration Test of paragraph 7.2.10 at the 7 2-8 Free Drop Test discretion of the test engineer. 7 2-5 6 Data and Results ne free drop test is intended to simulate the Observations shall be recorded. Photographs and video tapes will be taken. Failure criteria type of shock that a package would experience if it were to fall off the platform of a vehicle or if it shall be failure of the device to complete 10 satisfactory exposure cycles, loss of use of the were dmpped during handling. handle or failure of the Radiation Shielding Test. 7-2 8-2 Discussion 7-2-6 Water Spray Test Since the Titan GRED will be subjected to a 9 m drop test, the requirements for the free drop test 7-2 6-1 Purpose are exceeded and there is therefore no need to I perform this test. l Thepurposeof theWaterSprayTestis to l subject the device under test to a simulated 72-9 Stacking Test i rainfall of 50 mm per hour for at least one hour, his test would reveal any problems with 7-2 9-1 Purpose packagings vulnerable to water saturation. 7 2-6-2 Discussion 1 The stacking test is designed to simulate the dads pressing on a package over a pmlonged ! penei of time and is intended to ensum that the The Water Spray Test is particularly intended i effectivere of the shieldmpnd containment for packagings where distance shielding may rely on non-metallic materials which are ' systems willnot udrp9ed . softened by water or materials bonded by water

7 2 9-2 Discussion

< soluble glue. Since the structure of the exposure 4 idevice is made entirely of metal,it is not {Becauseof theshapeof theTitanGRED, vulnerable to such conditions. Hereis

stacking of the device is improbable and nerly

. therefore no need to perform this test. iim@le.Thereis themfore no need to e perform this test. t )7 ic ..A ,a i ~ 93 MAQCEUCf ' is ot2s. " ~ 'j ; I

J UNCONTROLLED COPY l nidd#laWAa A ln.nu NOT FOR GFNFA Al llRP -

DESIGN SPECIFICATION IS/DS 0055 N990 (REV B) 7-2-10 Penetration Test

4) Release the bar.

7-210-1 Purpose

5) Record any observations on the Penetration Test Data Sheetin Appendix A. Video

) The purpose of this test is to demonstrate that tapes, sketches and photographs are the exposure device can withstand the impact required to support the observations. that the device may receive during normal conditions of transport. The test simulates the

6) Repeat steps 1 to 5 for all of the areas of the exposure device being struck by a slender object device listed in paragraph 7.2.10.4.

such as a length of metal tubing or the handlebar of a falling bicycle. The test is a

7) Connect the remote control and projection transport requirement (reference 6).

sheath to the exposure device and perform 10 exposure cycles. 7 2-10-2 Equipment The equipment required consists of a 32 mm bar and a guide tube to direct its fall. The bar shall Observations shall be recorded on the have a hemispherical end and a mass of 6 kg. Penetration Test Data Sheet. Sketches, h P otographs and video tapes shall be taken. The exposure device shall have been subjected to the Handle Wrench Test of paragraph 7-2-5. Failurecriteria shallbefailureof thedeviceto complete 10 satisfactory exposure cycles or 7-2-10-3 Location failure of the Radiation Shielding Test. The testing will be performed at Nordion 7 2-11 Puncture Resistance Test Intemational, Kanata, Ontario. 7 2-104 Approach The purpose of the Puncture Resistance Test is The bar will be dropped vertically so as to strike to simulate accident conditions and to the exposure device at the following sensitive demonstrate that the source is not accidentally areas: exposed as a result. bottom of exposure device 7 2112 Equipment e side of exposure device e front oflock The equipment used for this test includes a 9 m e drop tower, an unyielding surface and a mild e side oflock steel pin with a diameter of 150 mm and a length of 200 mm. The exposure device shall The height of the drop shall be 1 m measttred have been subjected to the endurance test of from the lower end of the bar to the intended paragraph 7-1-2. point ofimpact. 7-2-113 Location 7-2-10-5 Procedute The Accidental Drop Test will be performed at

1) Position the exposure device so that the AECL Research, Chalk River Laboratories, targetimpact areais facing up.

Chalk River, Ontario.

2) Using the guide tube, adjust the relative 7-2-114 Approach position of the bar and the exposure device so that the bar will fall vertically and strike The test will consist of a 1 m drop onto the end the target impact area when releascd.

of a cylmdrical target such as to cause the =raimum damage to the device under test. The

3) Adjust the height between the bottom of the taq;et will be rigidly mounted perpendicularly bar and the targetimpact area to Im.

to an unyielding surface. The surface consists of a 100 mm thick steel slab on a cubic block of i*HnN m " - 17 of 25 UNCONTROLLED CMY h j m ; _J, NOT FOR GFNFRAL USF

DESIGN SPECIFICATION IS/DS 0033 N990 (REV B) concrete measuring 3 m on each side. The drop followed by a 9 m oblique drop in the concrete sits on bedrock. orientation shown in Figure 8. The second prototype will be s bjected to a 9 m drop 7-211-5 Procedure directly onto the lock. See reference 5 for further discussion on the drop orientations.

1) Suspend the exposure device in the upright orientation so that when released the lock 7 2-12 5 Procedure will strike the pin. lioist it so that the height measured between the upper surface of the

1) Suspend the exposure device in the upright pin and the bottom of the lock is 1 m.

orientation and hoist it so that the height measured between the upper surface of the

2) Start the high-speed camera and release the target and the lowest point on the exposure exposure device.

device is 9 m.

3) Record the results, including observations,

2) Start the high-speed camera and release the sketches and photographs of the damaged exposure device.

areas.

3) Record the results, including observations, 7-2-11-6 Data and Results sketches and photographs of the damaged areas.

The Puncture Resistance Test shall be documented with high-speed video,

4) Repeat steps 1 to 3 with the exposure device photographs and sketches. The exposure device oriented for a comer drop as shown in need not be operational after the test, however Figure 8. Ensure that the centre of gravity of the radiation fields are not permitted to exceed the exposure device is aligned vertically 10 mSv/h (1 rem /h) at 1 m.

over the lower comer. 't -2 12 Accidental Drop Test

5) Repeat steps 1 to 3 with the exposure device oriented so that the primary impact will be 7 2-12-1 Purpose on the lock.

The purpose of the Accidental Drop Test is to simulate an accidentalimpact and to demonstrate that the source will not be accidentally exposed as a result of such an impact. 7-2-12-2 Equipment The equipment used for this tes't includes a 9 m drop tower and an unyielding surface. The exposure device shall have been subjected to a Puncture Recistance Test of paragraph 7-2-11. 7-2-12-3 Location 9m The Accidental Drop Test will be performed at AECL Research, Chalk River Laboratories, Chalk River, Ontario, u I I 7-2-12-4 Approach /////////// A total of three 9 meter drop tests will be Figure 8 completed using two prototype units. One 9 m Corner Drop Test prototype will be subjected to a 9 m upright . d. = & ONCONTROLLED COPY 93 MAY 18 of 25 ma, _ A.m u NOT FOR GFNFR AI IleF

i \\ DESIGN SPECIFICATION IS/DS C055 N990 (REV B) 7 2-12-6 Data and Results The only material susceptible to a fire is the epoxy foam which fills the void between the The Accidental Drop Test shallbe documented outer structure and the depleted uranium with high-speed vide o, photographs and shield. The shield is structurally supported by ] sketches. The exposure device need not be means other than the epoxy foam and shielding l operational after the test, however the radiation provided by foam is insignificant. There is I fields are not permitted to exceed 10 mSv/h therefore no need to perform the fire test. l (I rem /h) at 1 m. 7-3 Tests On The Remote Control Device 7-2-13 Fire Test n ng est 7 2-131 Purpose The purpose of the Fire Test is to measure the 7-31-1 Purpose resistance of the test specimen to an accidental fire condition. The Purpose of this test is to ven.fy that the remote control cable and sheath can withstand 7-213-2 Discusion the stress due to lankmg that may occur during normal use. The fire test is intended to demonstrate that the radioactive material's shielding and 7-3-12 Equipment i containment are not vulnerab e to an accidental l fire with a temperature of 800 C and duration The remote control device wd. l have been of 30 minutes. subjected to the Projection Under Stress Test of paragraph 7-1-1. The C990 source assembly has been demor.strated to meet special form requirements ne test apparatus used is shown in Figure 9. and can therefore withstand such a fire. The ne rem te control sheath will be pulled shielding material is depleted uranium which manually, and the speed will be measured usipg l has a melting point of 1200 C and will therefore an Ametek digital tachometer with a linear survive a fire. The outer structure of the TITAN measurement adaptor. is made of titanium which has a melting point of 1670 C and can also withstand a fire. 50 cm l REMOTE CONTROL SHEATH AND CABLE ] 355 5

c l

l CABLE CLAMP CABLE GUIDE WITH SENSOR Figure 9 Remote Control Kinking Test Setup l l Its of 25 UNCONTROI LED Q)S)(y _w... m. i lm.- NOT FOR GENERAL USE

DESIGN SPECIFICATION IS/DS 0055 N990 (REV B) 7-3-1-3 Location

5) Repeat steps 1 to 4 with the loop at different locations on the sheath until 10 satisfactory i

l The testing will be performed at Nordion tests have been performed. l . Intemational, Kanata, Ontario. l 7-3-16 Data and Results 1 7-3-14 Approach All observations shall be recorded on the data l The cable will be laid out on a flat surface with a sheet provided. Each trial will be video taped 500 mm diameter loop and one end secured. and the test setup will be photographed. The The free end of the cable will be pulled at a rate failure criterium will be failure of the final of 2.0 m/s i 10% until the loop has disappeared. Projection Under Stress Test. The test will be repeated 10 times with loop in different locations. 7-3-2 Crushing Test 7-3-1-6 Procedure 7 3-2-1 Purpose

1) Arrange the control cable and sheath on the The purpose of this test is to demonstrate that test apparatus with a loop 500 mm in the remote control cable can withstand the stress diameter as shown in Figure 9.

of the heel of a 100 kg person impacting at a horizontal and vertical speed of 0.8 m/s.

2) Secure one end of the sheath using the clamp provided.

7-3-2-2 Equipment

3) Pull the free end of the sheath at a speed of The test apparatus is shown in Figure 10. The 2 m/s until the loop has disappeared.

remote control device shall have been subjected

4) Verify that the speed was between 1.8 m/s and 2.2 m/s. Record any observations on j

l the Remote Control Kinking Test Data Sheet in Appendix A. Mark the sheath to indicate the location where the test was performed, rg 70 ^ 70 10 Axis horizortal ./. I i / ri:.d@e rad 612 mm / r : comer radil 5 mm g f I ' Heel

4 Sheath

/. v _= oim.nen.inmomei.e.NNNNNNV.isuri e. NNNNN N sNN Hom m Figure 10 ' Crushing Test Setup f?? l"" d[ UNCONTROLLED COPY-i f. J 16l111411 . Ad.C Em NOT FOR GFNFRAI IISF "

DESIGN SPECIFICATION IS/DS 0055 N990 (REV B) l 7-3-2-3 Location

5) Repeat steps 1 to 4 at 10 different points along the sheath. For five of the tests the l

The testing will be performed at Nordion projection side and reserve side of the l International, Kanata, Ontario. sheath shall be superposed vertically. For the other five tests they shall be side by side. l 7-3-2-4 Approach Note whether the control cable is in the i projection sheath or reserve sheath or both. The apparatus to be used for the test is shown in Figure 10. The mass of the heel and crank shall 7-3-2-6 Data and Results be 15 kg. The test surface shall have a mass greater than 225 kg. The heel will be dropped The observations will be recorded on the data from a height of 300 mm. The test will be sheet provided. Each trial will be video taped repeated 10 times at different locations along the and the test setup will be photographed. The cable. failure criterium will be failure of the final Projection Under Stress Test. 7-3-2-5 Procedure 7-3-3 Tensile Test

1) Arrange the equipment as shown in Figure

10. The sheath shall contain the control 7-3-3-1 Purpose cable. Fix the sheath using guides.

The purpose is to demonstrate that the control

2) Raise the arm and ve -ify that the height cable and sheath can withstand the tensile forces between the sheath and the heel in 300 mm.

that may be encountered during use.

3) Release the arm and allow the heel to swing 7-3-3-2 Equipment freely down onto the sheath.

The remote control device shall have been

4) Record any observations on the Crushing subjected to the Crushing Test of paragraph Test Data Sheet in Appendix A. Mark the 7-3-2. The test apparatus is shown in Figures 11 sheath to indicate the location where the test and 12.

was performed. ' EXPOSURE REMOTE CONTROL SHEATH FORCE PNEUMATIC DEVICE OR PROJECTION SHEATH TRANeDUCER CYLINDER t F i CLAMP ADAPTOR l AIR LINE I DATA l MOUNTING LOGGER l FIXTURE Figure 11 Remote Control Sheath & Projection Sheath Tensile Tests 11 # GipC cir ~ UNCONTROLLED QOiRXy 21of25 & uia; E n.i .A NOT FOA GFNFA Al llRF 4

_ -. = - .. ~ - l DESIGN SPECIFICATION IS/DS 0055 N990 (REV B) 7-3-3-3 Location

10) Record any observations and include a plot of the force profile from the data logger with ne testing will be performed at Nordion the results.

International, Kanata, Ontario.

11) Repeat steps 9 and 10 until 10 tests lutve 7-3-3 4 Approach been performed.

This test mnsists of two parts; first the remote 7-3 34 Data and Results contml sheath will be tested and then the control cable and crank mechanism will be ne observations will be recorded and plots of tested. the measured force profile will be provided. Each test will be video taped and the test setup in the first part of the test, the remote control will be photographed. The failure criteria will l . sheath will be tested. A tensile force of 500 N be failure of the final Projection Under Stress l (112 lb) will be applied for 30 seconds. The test Test or failure of the source assembly (see 1 willbe mpeated 10 times. paragraph 7.5.1.6). In the second part of the test, the crank 7-4 Tests On The Projection Sheath mechanism will be secured and the crank arm will be immobilized. A source assembly will be connected to the control cable and a force of 7-4-1 Kinking Test L 1000 N (225 lb) will be applied to the free end of the source for 10 seconds. ne test will be 7-4-11 Purpose J repeated 10 times. ne purpose of this test is to verify that the i 7-3 3 6 Procedure Pmjection sheath can withstand the stresses due l ' to kinking that may occur during normal use.

1) - Secure the exposure device as shown in Figure 11.

7-4-1-2 Equipment l

2) Connect the remote control sheath to the he Pmjection sheath shall have been subjected l

exposure device. to the initial projection Under Stress Test of l paragraph 7-1-1. De test apparatus is shown in l

3) Connect the tensioning apparatus to the Figure 12.

crank mechanism using the clamp adaptor. 7 4-1-3 Location

4) Apply aload of 500 N(112lb)for 30 s.

ne testing will be performed at Nordion

5) Record any observations and include the Intemational, Kanata, Ontario.

j plot of the force pmfile from the data logger with the results. 7 4-14 Approach l

6) Repeat steps 4 and 5 until 10 tests have been One end of the projection sheath will be secured.

psb med. A flat closed loop will be formed, with the fixed end under the loop. A hoop will secure the ends

7) Secure the remote contmlas shownin where they cmss so that the loop cannot come Figure 11. Immobilize the crank handle.

undone,yet will still allow the sheath to slide. A force will be applied to the free end of the

8). Connect a source assembly to the control Pmjection sheath at a tangent to the loop. ne i

cable. form will be applied such that it reaches 200 N l (45 lb)in 5 seconds. The force will then be held j

9). Apply a force of 1000 N (225 lb) for 10 s to for 10 seconds. The test'will be repeated 10 l

l the lock ball on the source assembly. times at the same place in the projection sheath. d s' ,m., i E j s 1 93 MAY ' ],O 22of25 UNCONTROLLED COPY d&&a.-e d!.dTNOTIFdR GENERAL llRF

IS/DS C055 N990 (REV B) DESIGN SPECIFICATION 7-4-15 Procedure 7-4-1-6 Data and Results

1) Arrange the projection sheath on the test All observations shall be recorded on the data l

apparatus with a loop 500 nun in diameter sheet provided. The force measurement will be as shown in Figure 12. The fixed end of the recorded automatically and a printout for each sheath must be on the under side of the loop. trial willbe included with the results. Each trial will be video taped and the test setup will be

2) Close the clamping hoop over both ends of photographed. The failure criterium will be the sheath where they cross in the loop so f ailure of the final Projection Under Stress Test.

that the sheath can still slide, yet the loop cannot become undone. 7-4-2 Crushing Test

3) Secure the exposure device using the 7-4-2-1 Purpose mounting fixture and attach the projection sheath to the exposure device. Attach the The purpose of this test is to demonstrate that other end of the projection sheath to the the projection sheath can withstand the stress of tensile test apparatus.

the heel of a 100 kg person impacting at a horizontal and vertical speed of 0.8 m/s.

4) Apply a force to the sheath so that the force reaches 200 N (45 lb)in 5 s. Maintain the 7 4-2 2 Equipment force for 10 s.

The projection sheath shall have been subjected

5) Record any observations including the final to the Kinking Test of paragraph 7-4-1. The test diameter of the loop in the Projection Sheath apparatus is shown in Figure 10.

Kinking Test Data Sheet in Appendix A. Attach the force measurement plot to the 7-4 2-3 Location data sheet. Mark the sheath to indicate the location where the test was performed. The testing will be performed at Nordion international, Kanata, Ontario.

6) Repeat steps 1 to 5 with the loop always at the same location on the sheath until 10 tests have been performed.

DATA LOGGER PNEUMATIC PRCklECTION SHEATH CYLINDER i 50 Cm ) CLAMPlNG CLAMP FORCE TITAN HOOP TRANSDUCER Figure 12 [ Projection Sheath Kinking Test 23 of 25 UNCONTROLLED SY } 44 NOT FOR GFNERAl. tjSF

~ --w~. -~ ~. (S/DS 0059 N990 (REtf B) IN SPECIFICATION b 7-4-3-4 Approach 7-4-24 Approach The projection sheath will be connected to the The apparatus to be used for the test is shown in exposure device and the exposure device will be Figure 10. The mass of the heel and crank shall fixed so that it cannot move during the test. A be 13 kg. The heel will be dropped from a tensile force of 500 N (112 lb) will be applied to height of 300 mm. The test will be repeated 10 the sheath for 30 seconds. He test will be times at different locations along the sheath. repeated 10 times. 7-4-2-6 Procedure 7 4-3 6 Procedure

1) Arrange the equipment as shown in Figure

1) Secure the exposure device as shown in 10, Figure 11.

2) Raise the arm and verify that theleight

2) Connect the projection sheath to the between the sheath and the heel is 300 mm.

exposure device.

3) Release the arm and allow the heel to swing Connect the tensioning apparatus to the 3) freely down onto the sheath.

opposite end of the projection sheath using the clamp adaptor.

4) Record any observations on the Crushing TestDataSheetin Appendix A.Markthe

4) Apply aload of 500 N (112lb) for 30 s.

sheath toindicate where the test was performed.

5) Record any observations. Plot the force profile from the data logger and include it

5) Repeat steps 1 to 4 at 10 different points with the results.

along the sheath, one of which shall include a connection.

6) Repeat steps 4 and 5 until 10 tests havebeen performed.

7-4-2 6 Data and Results 7-4 3 6 Data and Results The observations will be recorded on the data sheet provided. Each trial will be video taped The observations will be recorded and each test I and the test setup will be photographed. The will be video taped. The measured fome profile failure criterium willbe failure of the final will be plotted and the test setup will be Projection Under Stress Test. photographed. The failure criterium will be failure of the final Projection Under StressTest. %3 Tensile Test, 7-5 Tests On The Source Assembly 7-4-31 Purpose The purpose of this test is to demonstrate that 7-5-1 TensileTest the projection sheath can withstand the tensile forces that may be encountered during use. 7m Pup 7 4-3 2 Equipment The purpose of this test is to demonstrate that the soume assembly can withstand the tensile The projection sheath shall have been subjected - forces that may be encountered during use. to the Crushing Test of paragraph 7-4-2. The test apparatusis shown in Figure 11. 7-512 Equipment 7-4-3 3 1.ocation The source assembly shall have been subjected tk Projection Under Stmss Test of paragraph 1he testing willbe performed at Nordion s p ' International,Kanata, Ontario. >~: a :. 2 y

khp, 88 UNCONTROLLED COP 1 Mf"

, MMUM2ig, ~.n. a.xm

~ l IS/DS C055 N990 (REV B) DESIGN SPECIFICATION 7-5-1-6 Data and Results i 7-5-13 Location . De observations will be recorded on the data The testing will be performed at Nordion sheet provided. Each test will be video taped Intemational, Kanata, Ontario. and the test setup will be photographed. The source assembly shall not show an elongation of 7-5-14 Approach more than 1% of its length. A control cable will be attached to the soure assembly and the opposite end of the source assembly willbe fixed. A tensile force willbe 8 REFERENCES ANSIN432 "RadiologicalSafety for'the Desi n gradually applied to the control cable so as to 1) 5 attain a load of 1000 N (225 lb) after 10 seconds. and Construction of Apparatus for Gamma he force will be maintained for 30 seconds. Radiography", August 1980 he test willbe repeated 10 times. 2) ANSI N43.9 "Camma Radiography - he largest diameter of the locking ball will be Specifications for Design and Testing of fixed and the testing will be repeated. Apparatus" October 1991. 7-5-1-6 Procedure -

3) Title 10, Code of Federal Regulations, Nuclear Regulatory Commission, Part 34 - Licenses for

1) Measurethelengthof thesourceassembly.

Radiography and Radiation Safety his must be done using a calibrated Requirements for Radiographic Operations. instrument.' Record the measurement and the calibration date of the measuring device. Title 10, Code of Federal Regulations, Nuclear 4) Take a magnified photo of the source Regulatory Commission, Part 71 - Packaging assembly and connector. and Transportation of Radioactive Material.

2) Attach a control cable connector to the TR-9240-N990, Safety Analysis Report for the 5) source assembly.

Titan Radiography Device,Nordion IntemationalInc.

3) Secure the opposite end of the source 6)

Regulations for the Safe Transport of assembly (i.e., the capsule) using the source clamp provided. Radioactive Material,1985 Edition (As Amended 1990),IAEA Safety Series No. 6,

4) Apply a tensile force gradually to the cable IAEA, Viemui,1990.

connector so as to reach 1000 N (225 lb) after 10 s.-

7) Transport Packaging of Radioactive Materials Regulations, Atomic Energy Control Act, I5) Maintain this force for 30 s.

SOR/91-304,9 May 1991. 8) IS/QP 0052 N990, Quality Plan for the Nordion

6) Record any observations on the Source AssemblyTensile Test Data Sheet in Titan Gamma Radiography Exposure Device.

Appendix A. Plot the force profile from the data logger and attach the plot to the data sheet.' After the testing, take a magnified photo of the source assembly connector.

7) Repeat steps 4 to' 6 until 10 tests have been performed.

8) Repeat steps 3 to 7 with the locking ball l

secured. R e : 93 MAY M%8 25 of 25 ' UNCONTROLLED COPY Uk%I5 - ~,2NOT FOR GENER AL USE +

. _ = _ - -. DESIGN SPECIFICATION IS/DS 0055 NMO APPENDIX B Special Form Radioactive Material Test Summary j s Certificate, Scaled Source Classification Designation and Performance (ANSI N542 1977) 1 I i i t ) ~ ~r e,z. cut. d![s. ' hQg,

!';kurw>,,

[d I M/PR[$CinTkyDDRc UNCONTROLLED COPY d1Ashiilw.arn... ..N.-.[$91SEEn, u,.,,.u-,., gn7 yn, n y,,,

l SP ECIAL FO R VI 9A JIOAC-~ V E IV A-E 9 A l ~~ES-~

SUMMARY

The capsule model specified herein has been evaluated in accord with the intemational Atomic Energy Agency l (l.A.E.A.) Safety Series No. 6, Regulations for the Gate Transport of Radioactive Materials.1985 Edition Section VI, paragraphs 604 613 and 618. TEST

SUMMARY

NO: 25 DATE: 1992 Julv 20 CAPSULE MODEL: C-990 CONTENTS: Iridium-192 DRWG NO: K122213-600 CAPSULE MATERI AL: 316L Stainless Steel OVERALL DIAMETER: 0.187 inches ENCAPSULATION: Single OVERALL LENGTH: 0.775 inches SPECIAL FORM REQUIREMENTS (1) TEST PASS Fall METHOD REMARKS fr$A X Comparison Comments below s P CUSSION X Comparison Comments below UhDING Not required s T X Comparison Comments below gg@hHING l X Comparison Comments below (1) See specal form requirements on reverse side COMMENTS: - The C-343 has been tested and has passed all Special Form tests, and has been certified to meet the requirements for Special Form via Certificate CDN/0001/S. Since the containmer.t s" stem for the C-990 is identical to the C-343, the v-990 also meets the reouirements for Special Form. This summary verifies that the described capsule model meets the requirements of Special Form in accord with the I.AE.A Safety Series No. 6, Regulations for the Safe Transport of Radioactive Materials,1985 Edition, Section VI, paragraphs 604-613 and 618. Testedby M. Krzaniak, P.Eng.& Authorized G A. Burbidge - g Title Develooment Officer U Manager, Package $ngineering 7;ff, 92h 80 Date 4WW/2/ Date NORDION INTERNATION$LINC. -- ~ u m)~ e; 2,f. 4t u.y n7 m y nggyn,, n y + 4 _m

i CERTIFICATt-SEALED SOURCE CLASSIFICATION DESIGNATION AND PERFORMANCE Sealed sources are classified in accord with standards established by THE AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI) and THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) CERTIFICATE NO: 76 DAYE: 92 August 20 CAPSULE MODEL: C-990 CONTENTS: Iridium-192 DRWG. NO: K122213-600 CAPSULE MATERIAL: 316L Stainless Steel OVERALL DIAMETER: 0.187 inches ENCAPSULATION: Single OVERALL LENGTH: 0.775 inches ANSI CLASSIFICATION AND PERFORMANCE STANDARD W lANSl77 C43515 l ) CLASSIFIED PERFORMANCE STANDARD (2) TEST CLASS METHOD REMARKS TEMPERATURE 4 Comp ison Pass (See Comments) EXTERNAL PRESSURE 3 Comparison Pass (See Comments) IMPACT 5 Comparison Pass (See Comments) VlBRATION 1 No Test Reqd. PUNCTURE 5 Comparison Pass (See Comments) (1) See definition on reverse side (2) See Table 1. Performarco Standards on reverse side (3) Amencen Nanonal Standard N6421977is a reviemn of ANSI N5,101948 COMMENTS: The C-343 sealed source has been tested and found to meet the performance' requirements of ANSI N542-1977 classification C43515. Since the containm'ent system for the C-990 as identical to the C-343, the C-990 meets the same performance requirements. It is hereby certified that the descrbed sealedsource meets the specified standardas prescnbedinMAmerican NationalStandard NS421977'SealedRachoactive Sources Classification". This standardcorrp4es with the classification andperformance requirements ofISO 2919 1980(E). Testedby M. Krzaniak. P. Enc. Authorized G.A. Burbidae Title Development Officer Title Mangger Package Engineerirg Date MS8 92)C/W Date kb SYO*f2S .) 0 NORDION & g' INTERNATIONALINC.; q,. y"M ' NA N # s ia i n a a eem A f f 7 g, m~w-ggj j",u.. NOT FOR GENERAL llSE -

REFERENCES

0) DEFINITION. CLASSIFICATION DESIGN ATION:

1 The class: Acanon of a sealed source shal be desegnated by tie code ANSI followed by two dets to indcate the yo y of apprtsal o Amencan Nasonal Standard used to desarrrone tie etassif! canon followed by a letter and frve ogits. Tha letter shall be ertier a C or an E. The leser C designates that the contained acevity does not exceed the maximum levek estath%hed by ANSI. The leser E doesgnases tint the contheied ac8vdy esoseds the mammum levels estabiisned by ANSI. The Erst det shal be tie ciens number whsch dosaibes sie perbrmance standards for temperature The eeoond det shall be tie ciens riumber which desenbos the performance standards for extemal pressure. The thrd dyt shal be tie cease number which desaibes the portorrnance standards for impact. The fourth digit shall be the class number which desaibes the performance standards for vibranon. l The fifth det sha5 be the class number which describes wie performance standards for puncture. (33 TABLE 1. PERFORMANCE STANDARDS: TEST CLASS 1 2 3 4 5 6 X Tempersture No Test -40'C (20 min) MC (20 moi) -40'C (20 min) -40'C (20 min) MC (20 min) Special +40'C (th) +180'C (lh) +400'C (t h) and +400'C (th) and +400*C (t h) and Test tiermalshock Wiermalshock tiermal shock i 400'C e 20'C 600'C m 20'C 800'C e 20*C Esternal No Test 25kN/m abs. " kN/m8 8 Pressure (3.6 blin ) $M 25 kN/m2 2 2 2 25kN/m abp 25 kN/m abg Sosaal to 7 MN/m to 70 MN/m m 170 MN/m Test 2 a 8 e agnosphere ab (1015 blan ) (10153 lbtin ) (24 656 bein ) = h abs. abs. abs. Impact No Test 50 g (1.8 oz) 200 g(7oz) 2 kg (4.4 b) 5 kg (11 b) 20 kg (44 b) Speaal from 1 m (3.28 ft) trom 1 m from 1 m from 1 m from 1 m Test and free drop ten smos e a steel surface from 1.5 m (4.92 ft) Vibration No Test 30 min 25 to 500 30 min 25 m 50 90 min 25 m to Not Used Not Used Speaal Hz at 5 g peak Hz at 5 g peak Hz at 1.5 mm Test arep. amp. and 50 to amp. peak to 90 Hz at 0.635 peak and so e mm amp, peak to 2000 Hz at 20g peak and 90 to 500 Hz at 10 g Puncture No Test 1 g (15.4 gr) from 10 g (154 gr) 50 g (1.76 oz) 300 g (10.6 oz) 1 kg (2.2 b) Speaal 1 m (3.28 ft) from 1 m from 1 m from I m from 1 m Test Il U

J

@IfRDION N T10NALINC. !447 March I oad, P.O. Box 13500, Kanata, Cnterw. Canade K2K IXR Tel.:(613) 592-2790 Tekx:(053) 4162 Fax:(613) 592 6937

L & 447 chemut March, C.P.13500. Kanaan. Cntario. Canade K2K IX8 T61.:(613) 592-2790 T64x:(053) 4162 Fax;ff6,1)yfx.{tW,,.,

,,,n, I a.., ~ ~ - i sia is. : C s i',, 4 A NOT FOR GFNrAAl llRF 4

TR-9412-C990(A) 4 Appendix 4. Special Form Radioactive Material Certificate No CDN/0001/S (Rev. 12) l i t l 9 DEC 1994 ,'. r.,. m~.,, y,. s, + * ,*s. u s,..,

~ - - - - lg Certification i 4 i EAE Atomic Eneigy Commksion de contcle jg 5YE control Board de14nergie atomique 1 j SPECIAL FORM RADIOACTIVE MATERIAL CERTIFICATE NO. CDN/0001/S, (REV. 12) 30 A2-187-0 September 3, 1992 The Atomic Energy Control Board hereby certifies that the capsules, as described below, have been demonstrated to meet the regulatory requirements j prescribed for special form radioactive material as defined in the Canadian Transnort Packarine of Radioactive Materials Rarulations and in the IAEA j Regulations *, subject to the following provisions. I j QAPSULE. IDENTIFICATION j Nordion International Inc., Capsula Assemblies as listed below, i j CAPSULE DESCRIPTION i The radiography capsula assemblies, as listed below, consist of single-walled encapsulated Type 316L stainless steel construction with external dimensions j 19.7 mm long by 4.75 mm diameter. The capsules are crimped onto a 3.2 mm j diameter 7-19 or a 2.34 me diameter 7-7 stainless steel aircraft cable i assembly or 3.6 mm diameter Nuclear Iberica cable assembly, incorporating a i variety of lengths, locking collars and end connectors which are specific to j sach capsule and their respective drawings: i 1 CAPSULE DRAVING CAPSULE DRAVING l i C-141 A07123 Rev. A C-262 A11542 Rev. C 1 C-142 A07117 Rev. A XC-266 A12671 Rev. D i C-148 A07118 Rev. A C-267 A12668 Rev. D l C-169 A07122 Rev. B C-272 A12950 Rev. D j C-175 A07116 'Rev. C C-291 A13796 Rev. C j C-187 A07119 Rev. A C-313 A16730 Rev. B j C-192 A07120 Rev. D C-337 A16827 Rev. G 4 XC-237 A07737 Rev. B C-340 A16833 Rev. H ]j C-245 A09425 Rev. G C-343 A17715 Rev. D C 259 A11539 Rev. F C-357 K121110001 Rev. A C-260 A11540 Rev. C C-359 K121104002 Rev. 5 C-261 A11541 Rev. E C-361 K121104003 Rev B C-369 K121104004 Issus B C-990 K122213-600 Issue 1 ~"~ Page 1 of 2..,,n. ~ ~ l , ~ r s n. ,u .s w. n.

O CDN/0001/S, (REV. 12) T 2 2 d The following capsule assemblies are also authorized: Length Diameter Capsule Drawing No. (mm) (mm) Encapsulation C-164 A05488,(Rev.D) 14.9 3.99 single C-204 A02029,(Rev.E) 15.0 5.5 single C-181 A05800,(Rev.D) 16.5 11.6 single C-349 A18351,(Rev.D) 0.1 i.57 single C-352 A18388,(Rev.C) 13.5 8.8 double XC-234 A07516,(Rav.E) 9.78 6.1 single AUTHORIZED RADIOACTIVE CONTENTS Each capsule is authorized to contain not more than 1850 CBq (50 C1) of cobalt-60 or 5550 GBq (150 C1) of iridium-192, in the form of solid metal pellets. EXPIRY DATE This certificate expires May 31, 1996 Q M -- = W.R. Brown Director Radioisotopes and Transportation Division REFERENCE

International Atomic Rnergy Agency Safety Series No. 6, Regulations for the Safe Transport of Radioactive Materials, 1973 Revised Edition (as amended).

. N.

1. Revision 4 June 7, 1983.

Capsula C-343 =AAnd. Certificate renewed.

2. Revision 5: September 22, 1986. Certificate renewed.

3. Revision 6: April 3, 1987. Capsules C-349 and C-352 added.

4. Revision 7: April 18, 1989. Capsules C-357 and C-359 added.

l Certificate renewed. l S. Revision 8: August 24, 1989. Capsula C-361 added. I

6. Revision 9: February 15, 1990. Capsula RC-234 added.

l

7. Revision 10: November 20, 1990. Capsula description revised and capsule C-369 added.

I

8. Revision 11. May 13, 1992. Certificate renewed..JNCC.vc

9. Revision 12. September 3. 1992. Capsula C-990 added.

~~ NOT:CFedsgg $b, /,.. l L.

i TR-9412-C990(A) l 1 i l l 4 l 1 Appendix 5. USNRC Quality Assurance Program Approval (Rev. 1) l I i l l s h j 10 DEC 1994 S, Jid. .,,.,-,,n w -.. .1 h' a 4.Y QS; a

i NRC FORM 311 / U. S. NUCLEAR REGULAir COMMISSION

1. APPROVAL NUM8ER f El

QUALITY ASSURANCE PROGRAM APPROVAL 0703 i

FOR RADIOACTIVE MATERIAL PACKAGES ^0N NUMBE R 1 k. { Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and Title 10, Code of Federal gf Regulations, Chapter 1, Part 71, and in reliance on statements and representations heretofore made in item 5 by the person named in it (f the Quality Assurance Program identified in item $ is hereby approved. This approval is issued to satisfy the requirements of Section 71.101 gt of 10 CFR Part 71. This approval is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commession ncw or q: hereafter in effect and to any conditions specified below, + p i II 2.NAME

3. EXPlRATiON DATE l

Nordion International Inc. 3 (i STREET ADDRESS July 31, 1995

h

( P.O. Box 13500

4. DOCKET NUMBER f

CITY STATE ZIP CODE f Kanata Canada K2K1X8 71-0703 l

5. QUALITY ASSURANCE PROGRAM APPLICATION DATE(S) k June 24. 1992 h

g

6. CONDITIONS il i

i 1. Activities conducted under applicable criteria of Subpart H of 10 CFR l Part 71 to be executed with regard to transportation packages. l 2. Domestic shipments (shipments which originate and terminate within the k United States) in packages which a foreign national competent authority 1: certificate has been revalidated by the Un'.ted States Department of 'l Transportation are not authorized. I 3. Records of instructions, procedures, drawings, and specifications as f} required by 10 CFR 171.135 must be retained for three years beyond the I date the activity ends, for which the QA Program was developed. l l l I Y I I I I I $il n I I ,I I ii I I I I I (E t dos fue u.s,wuctaAR REGUuTORY COMMISSION SEP 101992 Charles E. MacDonald lg

e N / g ~ l l-NOTE: S H A R.*^ D R ?/ E R R E Q UI RF D DO NoT CHAMrER GR RCur D off l .395- . OJ d].002_j = ( ) l / IA I y /7pyyp/// U s'j f e SIMA M DA Mxu -( / ) ,\\. h ) .IIl .s253 18 6 f I J //////, ////; u l .h / ~$ 093 mwd n2 .312 ^LlA l.O0osl ,,'f D/A x 45 C//AMMR ~ 317 M122 213.600 Mitif 04-oo2/oo4 WO i <@N -MWE AM SMAM MES M &M Al7785 2 \\ Assear Assess i tLSED ON U"*E'S O'#'EO ISSUE DESOUP110N DATE SY APPR DRAWd MN h3 30 /N L /MC, G D C R f 1576 89A4As GS a rf naaara caraaio caaaoa H D CR t 2.533 91sutas Gs. g(. y== sucr. eaa en em m oos==ams mt.E %[- MfMD3AR Sts' T DCN e A0031-D-Ol A %Ausz D. F. BASE CAPSUtE TYPE 316L, ASTM A2.16 ~ " " C ED was sanome a ne,sesseurv or ENWWahm WEESB OW W MEEE W SS AAE W WEMER SIZE DWG.NO. ISsVE A A,0,3 3,3 4, i I emenstamos vnnt nens enad. es no amenanou m m m "umans",* O"*o","mo"n'o"m *snes"en" m" " 2 .XX 2.00 5 2 ~ ga sCME d'! SHEET meenpenntees USED ON .xxx1

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_ _ = _ _ _ w-I 1 ~ l / \\ + l \\ / \\ / i N / 1 NOTES 1) REMOVE ALL SHARP EDGES AND BURRS. 2) HEAT TREATMENT PROCEDURE FOR SPECIFIED STOCK MATERIAL: MATERI AL RECEIVED IN " SOLUTION ANNEALED CONC FINAL TREATMENT: ~ SOAK IN FURNACE FOR ONE HOUR AT S2S C, FOLLOWED BY " AIR COOLING". 3) MACHINE AFTER HARDENING AND TEMPERING. ,h '4.Px hj$' ISSUE DESCRIPTION DATE BY B REDRAHN ON CADD C DCN # 90363 91apr23 HC 4 D DCR # 2533 92Jul28 CS y a p

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0.( -Z N m o one rn-( o e e m m o3 m4 [ ) N N ,- e ..e .-e + j}}). o o a o o o, u un nu U 0.0d 0.0$ NOTES 1) REMOVE ALL SHARP EDGES AND BURRS. 2) HEAT TREATMENT PROCEDURE FOR SPECIFIED STOCK MATERIAL: .l MATERIAL RECEIVED IN " SOLUTION ANNEALED COND FINAL TREATMENT: SOAK IN FURNACE FOR ONE HOUR AT 525 C, FOLLOWED BY " AIR COOLING". II 3) MACHINE AFTER HARDENING AND TEMPERING. ll ISSUE DESCRIPTION DATE Bk 2 DCN a 90564 A OCN # 90698 94may04 JHj B DCN a A0031-0-01A 94aug31 0.E. il 3 ' [,, 9s j-THI DRAWING IS THE PROPERTY OF NORDION INTERNATIONAL NdERS N ING T T ERE MALL N EXPLOITATION .s UEF62,"a"M 5 e sT sPNsafa JIE%"lis E ?#c. x1222;

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- - - - ,o FEB 131995 i

1 Mike Krzaniak Nordion International, Inc. 447 March Road Kanata, Ontario, Canada K2K

Dear Mr. Krzaniak:

Based on the information and test data submitted in your application dated November 23, 1993, and subsequent letters, with enclosures thereto, we conclude that the C-990 radiography source assembly is accepta'le for 4 u licensing purposes in accordance wJth the conditions of the enclosed registration certificate (NR-220A-110-S). Q Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your i application and subsequent letters, with enclosures thereto, and the 1 information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the I certificate. Please read over the registration certificate in its entirety and notify us j immediately of any errors or omissions. I You are obligated to notify us promptly in writing should you decide to no l j longer manufacture or offer service support for the product. Please be aware that, as a holder of an NRC registration, you may be subject i to the NRC's licensing and inspection fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-7544. I l i l 4 l l A N C " #, ? q. y cp u~. ?. \\

M. Krzaniak 2 If you have any questions, please contact me at (301) 415-7893 or Mr. Steven Baggett at (301) 415-7273. Sincerely, Thomas W. Rich, Mechanical-Engineer Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosure:

As stated cc w/ encl: SKimberley, LFDCB Distribution: SSSS Staff SCDB r/f (NE01) SSD 93-73 SSD file # NR-220-0-110-S DOCUMENT NAME: C:\\ssdtemp\\NR220110. cmp Te receive e copy of this document,inScate in the box: "C* = Copy without attachment / enclosure "E' = Copy with attachment / enclosure "N* = No copy l0FFICE SCDB l l l l l l l NAME Trich 'l.' M DATE 02/13 /95 0FFICIAL RECORD COPY f l 1

@ INTERNATIONAL 1995 January 18 FILE:IE1011.N990 i Mr. Tom Rich, Mechanical Engineer, Division of Industrial and Medical Nuclear Safety US Nuclear Regulatory Commission, Washington DC 20555

Dear Mr. Rich,

RE: Titan Device Approval (Response to Questions of 95/01/12) This letter responds to the questions asked in our phone conversation of 1995 January 12. I have paraphrased your questions in the order in which they were asked. 1) Redo the endurance test or provide additional justification that the existing test meets the requirements for device approval. A single teleflex cable has not survived through 20,000 cycles. Completion of another endurance test is practically impossible. There are two reasons for this: a) Both tested units have been drop tested from 9 metres in several different orientations. Damage as a result of these tests precludes additional endurance testing. b) There is no guideline for performing the endurance test. Decreasing the force applied may improve the life of the teleflex. However, it may not adequately test the camera or the remaining components of the peripheral equipment. Regulatory guidance is required. As stated in our application of 1993

November, and acknowledged by the USNRC in subsequent discussions, the endurance test specified by ANSI N432-80 is impossible.

It is known that the torque requirements specified by the standard cannot be achieved using teleflex cable. Quite simply, a single test in accordance with ANSI N432-80 will cause significant damage to the teleflex cable. Completion of 20,000 cycles at the specified load is clearly impossible. In fact, our submission is the basis for the current USNRC review of the endurance test requirement. 1995 JAN 18 PAGE 1 OF 5, N %O[g 447 March Road, Kanata,' Uniafioldal,ada K2K 1X8 Tel.:(613) 592-2790 Telex:(053) 4162 'Faxi(613) 592-6937 th. f il.:. .w ... ~.

4 In order to simulate the exposure that typical cables will have to endure, a number of dynamic tests were completed at j Nordion. (See Appendix D of TR-9302-N990 (B). ) Operators were asked to crank as hard as they could. The results showed a typical load of between 16 and 41 lbs for human operators. The test set up was calibrated to achieve a similar dynamic trace. Typical plots are attached, with some clarifications relative to Appendix D of TR-9302-N990(B). As you are aware, a total of 3 teleflex cables were used. A maximum of 13,500 cycles was achieved using a single cable. It must be emphasized that no significant damage was observed to the Titan projector or to any other part of the peripheral equipment. The only component vulnerable to the 20,000 cycle test at this force is the teleflex cable. No other parts were changed during the test cycles. Nordion submits that the completed endurance test meets the intent of the regulations on the following grounds: a) The area above the attached traces is a measure of the energy transferred to the cable. Comparison of the automatic and manual traces shows the force imparted by the test equipment is applied over a longer time interval than by a human operator. This time interval is at least 5 times as long.- (Please note the difference in time scale between the two attached graphs.) b) Damage was confined to two specific locations on the teleflex. These correspond to the two extreme source positions (ie. shielded and working position). The rest of the teleflex was undamaged. This indicates that the i failure is due to the high load imparted by the test 1 equipment at the two extreme positions. The kinking of the teleflex was observed at a point corresponding to the working position. It can be explained by the failure of the automatic clutch to quickly disengage. The residual compression on the teleflex caused it.to bend repeatedly within the control housing, ultimately resulting in a kink. If less force was applied, less kinking would have been apparent. Fraying anda damaged helix was observed at a point ) corresponding.to the shielded position. Residual tension l caused the gear wheel to " bite" into the teleflex, gradually wearing the teleflex. If less force was applied, less wear would have been apparent. Photographs of.the observed damage are found in Chapter 5 of the Titan User's Manual. w PAGE 2 OF 5 1995 JAN 18 1

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c) Applying a 16-40 lb load to the teleflex cable for 20,000 cycles is conservative. Typical average forces in the field will be less than these values. d) Failure of the teleflex is easily sensed by the operator. It manifests itself as a " crunchy" feeling when the source reaches either the camera or the source stop. e) Failure is gradual. There does not appear to be a sudden change in performance. Thus, there is ample warning time to enable the operator to take action. f) Teleflex cable is easily replaced. The process takes app'roximately'10 minutes. g) If failure occurs during an exposure, it merely makes it more difficult to retract or expose the sealed source. If failure is observed in the shielded position, the operator will not be able to expose the source. If failure occurs in the exposed position, the crank housing can easily be disassembled and the teleflex pulled by hand until the source returns to the safe position. 2) Clarity the statements in the endurance test logs for cycles 11,549 and 11,643. The confusion arises from the comment " Camera not locked" in the endurance test summary. This message was printed to the data file whenever a limit switch failed to indicate that the Selector Ring returned to the Lock position. In both cases the camera was locked but different faults caused the above message to be written to the data file. In cycle 11,549, the micro switch was loose and had to be tightened. The Selector Ring was observed to be in the LOCKED position. The loose micro switch failed to recognize this. In cycle 11,643, the adaptor rin ring slipped by approximately 1/g installed on the selector 8 inch. This was likely a gradual slippage as a result of the continuous vibration. This slippage caused misalignment between the adaptor and the micro switch indicating the Selector Ring had returned to the Lock position. Once more, the Selector Ring was in the locked position, but the misalignment caused the fault " Camera not locked." -3) Provide engineering drawings of the Selector Ring and Bayonet Connector. These engineering drawings will follow under seperate cover. Please note that the information contained in these drawings is proprietary to Nordion. The Titan has a new unique design PAGE 3 OF 5; 1995 JAN 18 f. a. . % di..

..m.__ and the information contained on the drawings includes j dimensions, tolerances and other information that would enable j the bearer to manufacture the unit, thereby affecting the economic viability of the project. An affidavit from an officer of Nordion will accompany the drawings, and will be j accompanied by a cover letter to Mr. Tom Rich. 4) Provide a written statement that the F-365 is identical to the SPEC-Cl source changer. j All Nordion F-365 serials were purchased directly or indirectly from SPEC. Each unit is equipped with a system i that enables the user to connect the control cable to the source assembly without unlocking the source. In the F-365, p this'is accomplished using the lock plungers shown on the attached specification sheet. 1 j 5) Is Nordion a registered user of the F-3657 I Nordion is not currently a registered user of this source changer in the United States. The registration procedure is currently in progress. A copy of the registration will be forwarded as soon as it is available. 6) Provide a written statement that the QNDE label will only be i used on Titan peripherals. i A written statement will follow from Quality NDE Ltd d [ certifying this to be true. ~1) Justify that the void volume in the C-990 is greater than the l 0.10 ml required by ANSI N542 for the successful application of the hot liquid bubble test. It is recognized that the void volume within the' C-990 is less 4 2 than 0.10 ml.

However, this test, combined with visual examination of the weld, is used as an indication of a gross leak and not as a positive leakage test.

Our operators claim that it does have some value and that they have on rare 1 occasions observed a fine stream of bubbles from a defective 1. weld. ANSI N542 states that when volumes are less than 0.10 ml one i. _of the smear, dry wipe or immersion with' boiling tests is to 'be' performed. As Nordion does complete a dry wipe test prior to shipment, this requirement of the standard is satisfied. 8) Explain why 100% penetration is not required for production capsules. Welding'is only required to seal the capsule. There is no structural requirement for additional penetration. Howev.er, PAGE 4 OF 5 1995 JAN 18 > 7. < ,= a.n

.3

as 100 percent penetration is routinely achieved in production, specification IS/TS 0010 C000 will be changed to require 100 percent penetration for test welds. A copy of the new specification will be forwarded to you as soon as it becomes available. ) 1 9) The source guide tube kinking test used a loop. Justify that this is consistent with ANSI N432-80 and 10 CFR Part 34. The regulatory requirement for the source guide tube kinking test comes from 10 CFR Part 34 and not ANSI N432-80. The requirement of 34.20 (c) (7) is to complete a kinking test on the source guide tube that closely approximates the kinking forces encountered during use. As there is no test specified, Nordion chose to use the test quoted by paragraph 6.4.1 of ANSI N43.9-1991. (Copy attached.) As discussed, this test is considerably more severe than the test completed on the remote control cable and meets the intent of the regulations. I trust this information enables you to complete your review of the Titan application. Please contact me if you have any questions. Sincerely, ~ ff' M. Krzaniak, P.Eng Package Engineering Nordion International cc. P. Gray (Nordion) (without enclosures) PAGE 5 OF 5 1995 JAN 18 fR + .,p '- l ( .; p $ + ..s 4 35 a .a 4 s,4 ;.....

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l mQn yoggjoy l lNTERNATIONAL INC. 1994 December 19 FILE:IE1011.N990 Mr. Tom Rich, Mechanical Engineer, gMm T 4 Fo< Division of Industrial and Med,;al Nuclear Safety NM *+ 1 oi S US Nuclear Regulatory Commission, Washington DC 20555 l

Dear Mr. Rich,

RE: Titan Device Approval (Response to Questions of 94/11/25) This letter responds to the questions asked in your letter of 94 November 25. I have addressed each of your questions in the order in which they were asked. 7(t t dd ^ 1) Peripherals g g y. 3

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The source guide tube, control tube and hand crank are all labelled Quality NDE Ltd. (Quality NDE Ltd is the manufacturer of the peripheral equipment.) The male connector on the contrcl cable is engraved "Nordion" s / and is crimped onto the control cable. The source stop is permanently crimped onto the source guide tube and, therefore, does not require any additional label. Drawings for the relevant components are enclosed as described in the response to question 3. Exposure Device The radiation caution plate and the identification place are j attached using stainless stal Type U # 4 drive screws. The radiography source tag is attached using two stainless / steel flat head #10 screws. 2) Additional shielding has been added to Titan prototypes as 7 described in Appendix F of TR-9302-N990(A). The governing / requirement is the 50 mrem /hr radiation level at 50 mm from the surface. Production units are required to be manufactured in accordance with Nordion Specification IS/TS 0054 N990 (C). (Copy attached) This standard requires each unit to be radiographed and surveyed prior to acceptance. If a shield does not pass the requirements of the radiat. ion shielding test, it is rejected. l (See section 6-8 of IS/TS 0054 N990.)- PAGE 1 OF 8 DF 1994 DEC 19 sl1 <b. O' &m W I[40L7t','- V_ l r 447 March Road K ta,' Ontario. Canada 2K 1X8 Tel.:(613) 592-2790 Telex:(053 4162 Fax:(613) 592 6937

. -. _ ~ .-.~ These tests ensure that all new units meet the requirements of ANSI N432-80. 3) Please find enclosed the following engineering drawings: Quality NDE Ltd Drawings l QME692-990(A) Control Cable Assembly / i QME692 (A) Pistol Assembly / ) QME48906(A) Source Guide Tube with Tip QME48907 ( A) Source Guide Tube Extension Nordion Drawings A16832 (F) D898 Male Connector Cable End j A17714 (G) Connector Body Female (D-899) 4) Nordion has changed its definition of a n' Ir-192 curie. Previous correspondance was all based on an exposure rate constant of 550 mrem /hr/Ci at 1 meter. The new definition of / 480 mrem /h/Ci at 1 meter is consistent with ANSI N432-80. The main result of this change is that we are now licensing the Titan for a maximum of 140 Ci (5.2 TBq) of Ir-192. It must be emphasized that there are no changes to the maximum output of the C-990. The output of 120 Ci at 550 i mrem /h/Ci is equal to the output from 140 Ci at 480 mrem /h/C1. 5) Please find enclosed a new copy of the Titan Users Manual. / IS/OM 0090 N990 has been revised to incorporate your comments t/ 3 as well as those of the USNRC transportation group. The current issue is D. / i 6) The C-990 will normally be shipped in the F-365 source changer. It may also be shipped in an F-254, F-296 or an F- / 346. I have enclosed copies of the specification sheets for each of these as well as copies of the current licenses and endorsements. The attached, technical report TR-9412-C990(A) summarizes the information required for you to review the C-990 design. 7) Please find enclosed a copy of engineering drawing K122213-501 (C). This is a general information drawing for the Titan. The bumpers are called off as item 17. 8) The attached Figures 8.1 and 8.2 summarize the tests that were 4 completed on both Titan serials. Each box includes information on where the results of the tests are reported. Except where otherwise noted, the referenced appendices refer j to TR-9302-N990 (B), -which was submitted to you in November, 1993. I PAGE 2 0F 8 1994 DEC 19 w u :

These tests ANSI N432-80 ensure that all new 3) units meet the Please find enclosed th requirements of e following engineering d (WE692-990 (A) rawings: QME692 (A) Pistol AssemblyControl Cable Assembl QME48906(A) QME48907 (A) y Source Guide Tube ExtSource G N_gEdign_ppawings Tip ension / A16832 (F) A17714 (G) D898 Connector Body FenaleMale connector Cable E d 4) Nordion n Previous changed (D-899) has its constant of 550 mremcorrespondance definition 480 mrem was all base an of main res/h/Ci at 1 me/hr/Ci at 1 meter. d on Ir-192 an curie. Titan forult of ter is The exposure this consistent with ANSI N432new defini a maximum change is rate that we It of 140 C1 -80 The are / must be (5.2 TBq) of Ir-192.now licensing the maximum output ofemphasizedthat mrem /h/Ci is equal to ththe C-990 there are 5) The no changes IS/OM 0090 N990 has bPlease find enclos e output from 140 Ci at 480 output of 120 Ci to the at 550 a as well new copy of mrem /h/C1. as een revised to incorporatthe Titan Users Manu l those current issue is D. of the USNRC 6) transportation groupe your comments / a. The C-990 chan will t/ 346.ger. I haveIt may also benormally be The shipped each of theseenclosed copiesshipped in an F-254, in the F-365 endorsements. well as as of the F-296 orsource specification sheets for [ copies of the an F-The information r,equired fattached technical report current licenses f and 501 C).Please find enclosed or you toTR-9412-C990 (A) 7) review the C-990 designsummarizes the The (bumpersThis is a general inf a copy of engineering drawi are called off as item 17 ormation drawing for the Tng K122213-8) The attached Figures 81 completed itan. Except whereinformation on where th on both and 8.2 summarize the test Titan serials. 1993to TR-9302-N990(B)otherwise results Each boxs that were e noted of the tests includes the referenced appendisubmitted t which wa,s are reported. ces refer PAGE 2 OF 8

ember, 1994 DEC 19 1

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o m goggjoy m INTERNATIONAL INC. + 1994 December 19 FILE:IE1011.N990 Mr. Tom Rich, Mechanical Engineer, 3M % T4 Fw Division of Industrial and Med;:a1 Nuclear Safety N M 4 0-loi 5 US Nuclear Regulatory Commission, Washington DC 20555

Dear Mr. Rich,

RE: Titan Device Approval (Response to Questions of 94/11/25) This letter responds to the questions asked in your letter of 94 November 25. I have addressed each of your questions in the order in which they were asked. ,t, g,s.

.-[

1) Peripherals O J g The source guide tube, control tube and hand crank are all labelled Quality NDE Ltd. (Quality NDE Ltd is the manufacturer of the peripheral equipment.) The male connector on the contrcl cable is engraved "Nordion" s / and is crimped onto the control cable. The source stop is permanently crimped onto the source guide tube and, therefore, does not require any additional label. Drawings for the relevant components are enclosed as described in the response to question 3. Exposure Device The radiation caution plate and the identification place are j attached using stainless atcal Type U # 4 drive screws. The radiography source tag is attached using two stainless / steel flat head #10 screws. 2) Additional shielding has been added to Titan prototypes as described in Appendix F of TR-9302-N990 (A). The governing / requirement is the 50 mrem /hr radiation level at 50 mm from the surface. Production units are required to be manufactured in accordance with Nordion Specification IS/TS 0054 N990(C). (Copy attached) / This standard requires each unit to be radiographed and surveyed prior to acceptance. If a shield does not pass the requirements of the radiation shielding test, it is rejected. (See section 6-8 of IS/TS 0054 N990.)- PAGE 1 OF 8 OF 1994 DEC 19 S// r3 'h' ~1^ %,f 447 March Road Kan a ntario, Canada 2K 1X8 Tel.:(613) 592-2790 Telex:(053) 4162 F :(613) 592-6937 v~ ~ -

l l These tests ensure that all new units meet the requirements of ANSI N432-80, 3) Please find enclosed the following engineering drawings: Quality NDE Ltd Drawings QME692-990(A) Control Cable Aasembly / QME692 (A) Pistol Assembly- / QME48906(A) Source Guide Tube with Tip QME48907(A) Source Guide Tube Extension Nordion Drawings A16832 (F) D898 Male Connector Cable End A17714 (G) Connector Body Female (D-899) 4) Nordion has changed its definition of an Ir-192 curie. Previous correspondance was all based on an exposure rate constant of 550 mrem /hr/Ci at 1 meter. The new definition of / 480 mrem /h/Ci at 1 meter is consistent with ANSI N432-80. The main result of this change is that we are now licensing the Titan for a maximum of 140 C1 (5.2 TBq) of Ir-192. It must be emphasized that there are no changes to the maximum output of the C-990. The output of 120 Ci at 550 mrem /h/Ci is equal to the output from 140 Ci at 480 mrem /h/C1. 5) Please find enclosed a new copy of the Titan Users Manual. / IS/OM 0090 N990 has been revised to incorporate your comments t/ as well as those of the USNRC transportation group. The current issue is D. 6) The C-990 will normally be shipped in the F-365 source / changer. It may also be shipped in an F-254, F-296 or an F- / 346. I have enclosed copies of the specification sheets for each of these as well as copies of the current licenses'and endorsements. The attached, technical report TR-9412-C990(A) summarizes the-information required for you to review the C-990 design. 7) Please find enclosed a copy of engineering drawing K122213-501(C). This'is a~ general information drawing-for the Titan. The bumpers are called off as item 17, 8) The attached Figures 8.1 and 8.2 summarize' the tests that were completed on both. Titan serials. Each box includes information on where the results of the tests are reported. Except where otherwise noted, the referenced appendices refer to TR-9302-N990(B), which was submitted to you in November, 1993. PAGE 2 OF 8 1994 DEC 19 .e = c -f 14 -b +4 , -... - ~, .1 ~..

I have also enclosed Appendix 2.10-E of TR-9407-N990(A), " Technical Assessment of the Titan Gamma Radiography Exposure Device with Respect to the Requirements of 10 CFR Part 71." This appendix describes supplemental drop tests that were comple+er' in response to questions from the USNRC Transpotsation Group. 9) I have checked photographs of the test set up and found that the actual diameter of the source guide tube at the start of y. the kinking test was 50 cm. The requirement of ANSI N432-80 is for a diameter of 1 meter.

#"1.,

Nordion submits that this deviation from the test procedure is ,.o insignificant. The damage incurred as a result of thin test - comes primarily at the end. The decrease in loop diameter.r the source guide tube. The most significant effect of this ' (g from 1 meter to 50 cm does not impose substantial stresses on,ga test comes at diameters less than 10 cm. C a.. J ' .c /;. I have enclosed photographs showing the test set up prior to i a-and following the kinking tests. Photographs 9.1 and 9.2 show M ', e the test set up for the remote control cable and projection sheath respectively. As the remote control kinking test does n not specify the use of an intermediate hook, no significant effect is observed as a result of this test. The control cable merely uncoils. Photograph 9.3 shows the effect of the intermediate hook on the projection sheath. You will note the tight radius, hence high relative stress. Please note that there was no damage to the internal metal cable as a result of this test. 10) I agree with your comment regarding Section 7-3-3-5 of IS/DS 0055 N990. Step 1 correctly references figure 11. Please find enclosed Photographs 10.1 and 10.2 showing the test set up actually used in step 7. The pneumatic cylinder was attached to the pistol assembly and as shown in Photograph 10.1 and the locking ball was retained in the bracket shown in Photograph 10.2. / 11) Sections 5-1and5-4oftheUser'sManualhavebeenmodified.-[ Additional warnings have been added to the text. (See IS/OM 0090 N990(D) enclosed.) 12) Appendix C of the User's Manual has been updated and a new copy is attached. (See IS/OM 0090 N990(D) enclosed.) 13) There are no specific requirements for solvents and cleaners. 14) The term Principal Owner's License has been replaced with the / term licensee. Revision D of the User's Manual is enclosed. l PAGE 3.OF 8 1994 DEC 19 9YY % h ,x

...~- I 1 15) The external wipe test quoted under Daily Maintenance item (c) is required to meet the requirements for transport. Please note thac'the user is not required to swipe the S-tube.

Finally, I have also enclosed a copy of our Canadian device registration for your information and review.

I trust this information enables you to complete your review of the Titan application. Please contact me if you have any questions. 1 Sincerely, en M. Krzaniak, P.Eng Package Engineering Nordion International cc. P. Gray (Nordion) (without enclosures)' Mr. Cass.R. Chappell, Section Leader, Cask Certification Section, Transportation Branch, Division of Industrial and Medical Nuclear Safety, USNRC Washington, D.C. 20555 (with IS/OM 0090 N990(D) only) i i I i PAGE 4 OF 8 1994 DEC 19 Nw e tw et- -34 J I,WP / A N i ).$ A.ap 4.

l i i I 1 l nernese nom.w Rom.= 1 Centrol Conwel Centrol l Tenede KirAJng Ceveh feet Test Test App.L App.J App.K leveal Protoceen E.ndurense Mensental Veresel Hende Proposeen Asedental Finst Redaenen Under Test Sheet Sheek Wreneh under Dree Redenen $4ending Stroes Tus Test Test Sweee Teste 84deedne Test Test Test 44 Drapet Test l App.F App. 8 App.2 App.G See. 3.3 See 3.4 App. 8 App. I App.F pp.F6-F10 pp.SI 92 gg sp.01 GIC p.12 p.12 .3

p. F4 Preineen oud.

anse Sheeth Tidne Tube W Cn3 ---s ~ App. u App. s m S.ure. 1 Assamedyl Tensee d Tut App. o Figure 8.1 Test Sequence for Titan Serial Number 002 in,ed - rene.eeen Aae ornd F,nd w Redeelen Test Drop Redeskw I sneser Drup Redealen 9 snster Drop Shiedeng Tute Steendne Test SNeedne Teste Test (2 Drapel Test D (2 Deepel Test la App.F Ape. 8 App.1 App. F App.3.104 App.F App 2.104 pp FSf18 as.8142

p. F4 TR-940748908 p, F4 TR44074e99C l

Figure 8.2 Test Sequence for Titan Serial Number 003 l PAGE 5 0F 8 1994 DEC 19 1 i .c 4 4 \\4. 5 4

l l l I I'i I l I l l l J m-2 y k .h . 2Q,.. l i 1 _= o l l l Photograph 9.1 Remote Control Cable Kinking Test l 1 i 9 PAGE 6 OF 8 1994 DEC 19 i

I i T g. g h [ k . 41, - ~ ' p. t i r .i w .t-i l m - an. } t v 2 --k'- ~v ? J. t. \\ i \\ gb <. g .C l u .d$1 .\\ NM/}5.3a \\^' A ..~ .m i y .. - ~. l \\ ~ .i I ,A % l \\ 's f,:..Q +j-l ~ l ~ 'igne j' y, e l Figure 9.2 Projection Sheath Kinking Test l l i .-w r-w ' i.. 1 -) I a, ? m i j, .... L. l 4 4 ~

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i l ~ .. w 4 8 k Figure 9.3 Results of the Projection Sheath Kinking Test i k i 4 i l PAGE 7 OF 8 1994 DEC 19 4 l k 4 1 1 I -,m

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.s . IR s, % i,g < Figure 10.1 Setup for the Control Cable Tensile Test (Pistol End) .... ~ a.., m.... y - s - : ..z e. tt * $. 1 ,n' . ? ;,i.-k: e i 5 l- ~ y

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\\ g,, -,,3.., Figure 10.2 Setup for the control Cable Tensile Test (Source End) PAGE 8 OF 8 1994 DEC 19 1

(. - -. - ~. ~... -..~..._.._ } s v, 3 - 9 Ef. "L'r f l U 'S, lr. t _ 's - t ~ ~ f.. ~< l rc e q ~ e. g L- -s \\J ~ E44/ G.ta a -- m. l 1 - i l ,v l u. i ,,./ [ i ? t y i j Figure 9.2 Projection Sheath Kinking Test l y { 3 W 4 l i l N$ W. 'g g a g ~ e l ( ).. w Q l l l 1 e i ( z Figure 9.3 Results of the Projection Sheath Kinking Test f PAGE '7 OF 8 1994 DEC 19 l 1

I. J l 4 4 1 1 i f % '.3 ~ j .y e*,g % .i . q%' g, L ( 4 e N ^ ~ 4 -4 \\ ~ l s.. .< s, '4. . s t.. 9

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.A.. { 3 crg s-3, g(:2s l Figure 10.1 Setup for the Control Cable Tensile Test (Pistol End) t 4 -~. , a ',i.- I g... a g. g- +.

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~ . +.s, f. k ~ ~ 6, w.. 's g.q Q., r k .,,g '. s T-1 1 ,e l .%g,' ? t. n..g j 4, <, v., i 1 i Figure 10.2 Setup for the Control Cable Tensile Test (Source End) PAGE 8 OF 8 1994 DEC 19

a cto fr A l E E UNITED STATES l' 'i NUCLEAR REGULATORY COMMISSION [ W ASHINGTON, D.C. 2055'c0001 November 25, 1994 ) Mike Krzaniak Nordion International, Inc. 447 March Road Kanata, Ontario, Canada KL

Dear Mr. Krzaniak:

This letter is in response to your application dated November 23, 1993, requesting registration of the Model Titan Gamma Radiography Exposure Device and a follow-up to our latest telephone conversation on November 18, 1994. We are still working on a resolution of the ANSI N432-1980 endurance test requirement. In order for us to continue our evaluation, the following information is necessary: l 1. It is NRC's policy to label the associated equipment with a unique identifier that dist:nguishes your equipment from other off-the-shelf products. The associated equipment that needs to be labeled includes the guide tubes, control tubes, control cable, hand crank, and the source stop if it is not permanen., a..ched to the guide tube. Please state, and/or provide drawings or labels indicating how and where these accessories will be labeled. In addition, please state how the radiography exposure device's labels will be attached. 2. Please provide a radiation profile for the Titan containing the new shield. If one is not available, please provide justification that the radiography cameras will meet the acceptable radiation limits as specified in 10 CFR Part 34. 3. Please provide drawings of the accessory equipment listed in Item 1 above. Also include drawings with tolerances for the male cennecter attached to the drive cable and the female connector attached to the source pigtail. 4. Please provide the maximum activity that will be used in the camera. Please express this activity as defined in Section 8.1.2 of ANSI N432-1980. 5. Please provide Appendix B of the Titan User's manual. 6. Please provide the source changers allowed for use with the Model C-990. In addition, please provide all necessary information (see Regulatory Guide 10.11) for us.to review the source pigtail design. The sealed source stated for this camera has not been previously approved. The information should include the chemical form of the isotope and drawings showing source construction. 7.- P1 ase provide drawings showing the modified camera (bumpers installed). ____ 950213 { ) /r- \\ S)I O. ,WR RC.4-ber /A Psao .r ,,j#.

2 I M. Krzaniak 2 i 8. Please provide the test plan that was actually followed. After j previous discussion with you, it i my understanding that some of the tests shown in the plan, shown in 1.gure 1, page 5 of Appendix 4 were l removed. j 9. The kinking tests for the control and guide tubes does not meet the 4 requirements of ANSI N432-1980 and 10 CFR 34.20. The ANSI test procedure states that you are to make a loop 500 mm in radius not 500 mm diameter as stated in your test procedures. Please explain the discrepancy. If the tests was performed using the 500 mm diameter, please repeat the tests using a 500 mm radius and provide the results. 10. There appears to be an inconsistency with the tensile test to be 1 performed on the controls. Step 1 and step 7 of your procedure call out the same figure number 11 although they should show separate test setups. 11. The User's Manual needs to have stronger statements indicating that only licensed personnel qualified to perform service and maintenance are permitted to perform service and maintenance on the device. In particular sections 5.1 and 5.4 need to be updated. 12. Appendix C of the User's Manual needs to be updated. NRC has only four regional offices. 13. The User's Manual needs to address what solvents /degreasers the users can use. Past experience has shown that some solvents / cleaners can degrade the linings in the control tubes. 14. In Chapter 7 of the User's Manual, " Principal Owner License" needs to be defined. 15. In the User's Manu;1 in Chapter 5, under the daily maintenance section, iten (c), it states that the user i to perform a daily wipe test. This is not a NRC requirement and you may want to reconsider the benefits of this test requirement. .Many of the above items have been discussed with you during our telephone conversations on June 29, 1994, October 25, 1994, and November 18, 1994 and during your visit on July 27, 1994. However, we have not received any written responses.

j g wa.a

M. Krzaniak 3 Please provide the requested information as soon as possible. If you have any questions, please contact me at (301) 415-7893 or Mr. Steven Baggett at (301) 415-7273. Sincerely, / Thomas W. Rich, Mechanical Engineer Sealed Source Safety Section Source Containment and ' Devices Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution: SSSS Staff SCDB r/f (NE01) SSD 93-73 DCD DOCUMENT NAME: C:\\ssdtemp\\ titan.def To ncelse a copy of this document, indicate in the boa: "C' s Copy without attachment /enriosure

E* = Copy with attachment / enclosure
N* = No copy 0FFICE SCDB l

[ [ ] NAME Trich '/,0. 2, DATE 11/ 27/94 0FFICIAL RECORD COPY f

Jur, V.'op4e.4.etif,IM.

a i i M. Krzaniak 3 Please provide the requested information as soon as possible. If you have any questions, please contact me at (301) 415-7893 or Mr. Steven Baggett at (301) 415-7273. Sincerely, b l0 l Thomas W. Rich, Mechanical Engi neer Sealed Source Safety Section Source Containment and Devices Branch 4' Division of Industrial and Medical Nuclear Safety Office of Nuclear. Material Safety 4 { and Safeguards Distribution: d SSSS Staff SCDB r/f (NE01) SSD 93-73 DCD DOCUMENT NAME: C:\\ssdtemp\\ titan.def To ricalss a copy of this document, Indicate in the boa: "C" = Copy without attachment / enclosure "E* = Copy with attachment / enclosure

N' s No copy 0FFICE SCDB l

l l l l i NAME Trich '/,0. A l DATE 11/ 22/94 0FFICIAL RECORD COPY i A I 4 s 4 4 g, - Mte va

gano ( UNITED STATES L 4! NUCLEAR REGULATORY COMMISSION WASHINGTON. D C. 205554X)01 l November 25, 1994 \\ l Mike Krzar.iak l l Nordion International, Inc. 447 March Road Kanata, Ontario, Canada K2K

Dear Mr. Krzaniak:

This letter is in response to your application dated November 23, 1993, requesting registration of the Model Titan Gamma Radiography Exposure Device and a follow-up to our latest telephone conversation on November 18, 1994. We are still working on a resolution of the ANSI N432-1980 endurance test requirement. In order for us to continue our evaluation, the following information is necessary: 1. It is NRC's policy to label the associated equipment with a unique / identifier that distinguishes your equipment from other off-the-shelf products. The associated equipment that needs to be labeled includes >, 1.. the guide tubes, control tubes, control cable, hand crank, and the source stop if it is not permanently attached to the guide tube. Please state, and/or provide drawings or labels indicating how and where these l accessories will be labeled. In addition, please state how the radiography exposure device's labels will be attached. 2. Please provide a radiation profile for the Titan containing the new shield. If one is not available, please provide justification that the radiography cameras will meet the acceptable radiation limits as specified in 10 CFR Part 34. j 3. Please provide drawings of the accessory equipment listed in Item 1 above. Also include drawings with tolerances for the male connector / attached to the drive cable and the female connector attached to the source pigtail. 4. Please prcvide the maximum activity that will be used in the camera. / Please express this activity as defined in Section 8.1.2 of ANSI N432-1980. 5. Please provide Appendix B of the Titan User's manual. 6. P %ase provide the source changers allowed for use with the Model C-990. in addition, please provide all necessary information (see Regulatory Guide 10.11) for us to review the source pigtail design. The sealed source stated for this camera has not been previously approved. The l information should include the chemical form of the isotope and drawings showing source construction. 7. Please provide drawings showing the modified camera (bumpers installed). Illu lv % Q p;{e caua CD f a&%. 3 : tr ^-3MW n

4 4 M. Krzaniak 2 8. Please provide the test plan that was actually followed. After previous discussion with you, it i my understanding that some of the testi shown in the plan, shown in igu e 1, page 5 of Appendix 4 were removed. 9. The kinking tests for the control and guide tubes does not meet the requirements of ANSI N432-1980 and 10 CFR 34.20. The ANSI test procedure states that you are to make a loop 500 na in radius not 500 mm diameter as stated in your test procedures. Please explain the discrepancy. If the tests was performed using the 500 mm diameter, please repeat the tests using a 500 mm radius and provide the results. 10. There appears to be an inconsistency with the tensile test to be performed on the controls. Step 1 and step 7 of your procedure call out the same figure number 11 although they should show separate test setups. 11. The User's Manual needs to have stronger statement indicati.ig that only licensed personnel qualified to perform service and maintenance are 1 permitted to perform service and maintenance on the device. In particular sections 5.1 and 5.4 need to be updated. i 12. Appendix C of the User's Manual needs to be updated. NRC has only four regional offices. 13. The User's Manual needs to address what solvents /degreasers the users can use. Past experience has shown that some solvents / cleaners can degrade the linings in the control tubes, 14. In Chapter 7 of the User's Manual, " Principal Owner License" needs to be defined. 15. In the User's Manual in Chapter 5, under the daily maintenance section, item (c), it states that the user is to perform a daily wipe test. This is not a NRC requirement and you may want to reconsider the benefits of l this test requirement. Many of the above items have been discussed with you during our telephone conversations on June 29, 1994, October 25, 1994, and November 18, 1994 and during your visit on July 27, 1994. However, we have not received any written responses. i e e 1 4

M. Krzaniak 3 Please provide the requested information as soon as possible, if you have any questions, please contact me at (301) 415-7893 or Mr. Steven Baggett at (301) 415-7273. Sincerely, f0f Thomas W. Rich, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety i and Safeguards Distribution: SSSS Staff SCOB r/f (NE01) SSO 93-73 0C0 DOCUMENT NAME: C:\\ssdtemp\\ titan.def To arceive e copy of tNs decurnent, indicate in the box: "C" = Copy without attachment / enclosure "E* = Copy with attachment / enclosure "N* = No copy 0FFICE SCDB l l l l l NAME-Trich '/,0. A DATE 11/ 27/94 0FFICIAL RECORD COPY

,s po% o, f ). i '(( k UNITED STATES

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NUCLEAR REGULATORY COMMISSION ( s.. ,/ WASHINGTON, O C. 20555-0001 September 19, 1994 l Mr. Anthony LaMastra Chairman, Standards Committee N43 Health Physics Associates, Inc. 1005 Old Route 22 Lenhartsville, PA 19534

Dear Mr. LaMastra:

During a review of a recent application for evaluation of a new radiography camera, it was brought to our attention that the requirements for the endurance test referenced in American National Standard N432-1980 (ANSI N432-t 1980) was not realistic. In particular, the manufacturer provided information which indicated that the torque requirement (500L Nam), listed in section 8.9 of the ANSI guide, when applied to the teleflex control cable was in excess of the cable manufacturer's suggested cable load for a life of 10,000 cycles. In particular, for a typical 0.103 m (4.063 inches) crank lever the torque requirement is 51.6 Nem (38.1 ft-lbs). A typical control gear has a radius of 4.0 cm (1.6 inches). Therefore, the corresponding force (force - torque / radius of control gear) on the drive cable is 1276 N (287 pounds). This force exceeds recommended working load for Type 187 Teleflex Cable (see attached data sheets). Another manufacturer, located in an Agreement State, is in the process of testing their device and also claims that this torque value is not practical. In addition, it is our understanding that existing cameras in the field, both current and old designs, would fail if subjected to this test requirement. Could you please provide us with the Committees' interpretation or clarification of this test requirement. What was the justification for this value of torque?. Is the Committee aware of any manufacturer that has subjected their gamma radiography system to this specific torque requirement and passed the endurance test? If so, could you provide the manufacturer and model number of the radiography exposure device. We have contacted Amersham and Industrial Nuclear, and they stated that their cameras were not subjected to this specific torque requirement, but instead a value that was more realistic. Please provide us with the above information as soon as possible. Several licensing decisions are pending based on your response to this letter. $ f% Jg M VIV[ N 4 s/s,<y ~( ihm..

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.~ Mr. Anthony LaMastra 2 If you have any questions concerning this matter, please contact Thomas Rich of my staff at (301) 504-7893. Sincerely, C,tiad !!gc;d tri P.dnt L. Set Robert L. Baer, Chief Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety Of' ce of Nuclear Material Safety and Safeguards cc: Nancy Johnson, Health Physics Society John Taschuer, Los Alamos National Laboratory Charles Zegers, ANSI John Munro, III, RTS Technology DISTRIBUTION: SCDB r/f IMNS CenL al Files NMSS r/f SE:S Sts'# OFC: SCDBn //- SCDB,,, SCDk NAME: d!NGd(N SBakgYt RBI DATE: b9[/f 94 09 [/ /94 09// 4 /94 / 0FF;;CIAL RECORD COPY G:\\ANSILET. RAD 4 la ^d4 #w I J.m *% 4

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s.- Janu3ry 3, 1994 Nordion International Inc. ATTN: J. Stirling, Regulatory Affairs 4 i Specialist, Regulatory Affaire i 447 March Road P.O. Box 13500 Kanata, Ontario, Canada K2K Gentlemen: This refers to your letter dated November 23, 1993, for a sealed source and device registration for your Titan Gamma Radiography Exposure Device. Your requeut is subject to an application fee of $3 700 as specified in fee Category 9A of 10 CFR 170.31 of the enclosed July 20, 1993, Federal Realster notice. Payment of the $3,700 fee should be made to the U.S. Nuclear Regulatory Commission and mailed to the following address: U.S. Nuclear Regulatory Commission ATTN: Brenda Brown License Fee and Debt Collection Branch, OC/DAF Mail Stop KNBB 4503 Washington, D.C. 20555 4 If we do not receive a reply from you within 30 calendar u fs from the date of i this letter, we shall assume that you do not wish to pursue your apolication and will void this action. a Sincerely, -. _ ; ?. c ' + [. 3GW1 y I Brenda Brown License Fee and Debt Collection Branch Division of Accounting and Finance Office of the Controller Enclosures July 20, 1993, Federal Reaister notice cca S. Baggett DISTRIBUTION Pending Fee File OC/DAF R/F LFDCB R/F (2) i 1 l i ) OFFIC2: OC/LFDCB OC/LFDCB NAME: BBrown SKimberley j7/.7//f3 /2/ / DATE: PAW 2:\\NORDION.ANC i J sk a S__ v-_- - ~ e

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*.. ek January 3, 1994 Nordion International Inc.

ATTN J. Stirling, Regulatory Affaire Specialist, Regulatory Affairs 447 March Road P.O. Box 13500 Kanata, Ontario, Canada K2K Gentlemen This refers to your letter dated November 23, 1993, for a sealed source and device registration for your Titan Gamma Radiography Exposure Device. Your request is subject to an application fee of $3,700 as specified in fee category 9A of 10 CFR 170.31 of the enclosed July 20, 1993, Federal Recister notice. Payment of the $3,700 fee should be made to the U.S. Nuclear Regulatory Commission and mailed to the following address: U.S. Nuclear Regulatory Commission ATTN: Brenda Brown License Fee and Debt Collection Branch, OC/DAF Mail Stop MNBD 4503 Washington, D.C. 20555 If we do not receive a reply from you within 30 calendar days from the date of this letter, we shall assume that you do not wish to pursue your application and will void this action. Sincerely, r / Brenda Brown License Fee and Debt Collection Branch Division of Accounting and Finance office of the controller Enclosures July 20, 1993, Federal Recister notice cci ' S. ' Baggett " l i .)

0 4 % INTERNATIONAL INC 1993 November 23 b vf47 Mr. Steve Baggett, Section leader Source Containment and Devices Branch S #- g* g Scaled Source Safety Section M Mail Stop 6H3, Room 6D21 p SMAs ,9 United States Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, Maryland USA 20852

Dear Mr. Baggett:

RE: Application for USNRC Device Registration for the Titan Gamma Radiography Exposure Device Please accept this letter as the formal request of Nordion International Inc. to have, subject to regulatory approval, the above device duly registered by the USNRC. To support this request we enclose one copy each of the following reports for your inforuation: A. Test Report TR 9302 N990 - Test Report for the Titan Gamma Radiography Device B. Technical Report TR9303 N990 - Technical Assessment of the Titan Gamma Radiography Exposure Device with respect to the requirements of 10 CFR Part 34, ANSI N-432 - 1980 and 10 CFR Part 71 If you have any questions please call myself or Mr. Mike Krzaniak at 2035. Thank you for your attention to this matter. S!

erely,

- -.c - .,,,, w tirling uc,----------------- Regulatory Affairs Specialist i K fg g --{---- Regulatory Affairs fjg 7 j@8 ~~]((~~- _-] l 1 JS/im 1 2 ~ ~ cc: G. Burbidge l N -I . _ [_ $_~_~[ P. Gray L-. M. Krzaniak w J 6tcLp [f 447 March Road, RO. Box 13500. Kanata. Ontario. Canada K2K 1X8 Tei:(613) 592-2790 Tele c lO53) 4162 Fax:;6l3 e 592-6937 447 chemin March, C P 13500. Kanata. Ontario, Canada K2K 1X8 Tel.:i6131592-2790 Teter r053a 1162 Fax:1613I532 693 ~ .i1 i

a i NOTE TO SSSS MEMBERS

SUBJECT:

NORDION'S NEW RADIOGRAPHY CAMERA The device has not yet been submitted for evaluation undt 32.210, however, it has been submitted to Transportation for Type B approval. Bill Huddleston of INC called me on November 16, 1993 to discuss radiography in general and indicated that he had seen the Nordion camera on display at the recent ASNT show. Bill expressed some I concern about the operation of the automatic source capture mechanism. It seems, at least for the display model, that the source assemble stops before the capture mechanism and that the radiographer needs to apply additional force on the crank mechanism to get the capture mechanism to work as required by 34.20. If this is the case the radiographer is not likely to cae the capture feature of the device. You could go as far to state that the design allows for the user to decide when to use the capture mechanism. I don't think this was the intent of ANSI standard or the regulations on equipment. We should look at this detail of the camera during our evaluation of the Nordion camera and if it does occur this way, we should get Nordion to modify the' design to eliminate the need for additional force to use the capture mechanism. o ( 1 f p 'wt lG 4 thel & l s. i La.,,, g,k6.g .r, A b sr n a a n,., u. .., y,,,;.,, _, g w ~ r., .n a f " *$ Y* d e, rje a h. 4i. k,< t "p w * 'j h? she la me.~ eEet f 14 v <egalo L,n. fbriu s vs.< b,, o -> > r ;<, < 4 s a j +> a u m ihr 'u w G 6> H,. us e s a . s e

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ML20138F982

Text

SUMMARY

REFERENCES:

Dear Mr. Baggett,

Dear Mr. Govindapillai:

Enclosure:

SUMMARY

REFERENCES:

SUMMARY

REFERENCES:

1.0 INTRODUCTION

SUMMARY

SUMMARY

5.0 REFERENCES

1.0 INTRODUCTION

SUMMARY

SUMMARY

5.0 REFERENCES

SUMMARY

SUMMARY

Dear Mr. Krzaniak:

Enclosure:

Dear Mr. Rich,

SUMMARY

Dear Mr. Rich,

Dear Mr. Rich,

Dear Mr. Krzaniak:

Dear Mr. Krzaniak:

Dear Mr. LaMastra:

=

Dear Mr. Baggett:

SUBJECT:

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