ML20198D685
| ML20198D685 | |
| Person / Time | |
|---|---|
| Issue date: | 12/21/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20138M205 | List: |
| References | |
| SSD, NUDOCS 9812230175 | |
| Download: ML20198D685 (10) | |
Text
_ - . . . - - -= -_ .~ ._ . . . . - . . . . . . - -
l l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE l (AMENDED IN ITS ENTIRETY) l NO. NR-220-S-103-S DATE: D[C211998 PAGE 1 OF 8 SOURCE TYPE: Gamma Irradiator Source l
1
- MODEL
- C-188 (Series) Types 1 - 12 C-306 (Series) Types 1 - 3 MANUFACTURER / DISTRIBUTOR: MDS Nordion, Inc.
(formerly Atomic Energy of Canada, Ltd. and Nordion International, Inc.)
447 March Road Kanata, Ontario, Canada K2K 1X8 ISOTOPE: MAXIMUM ACTIVITY:
Cobalt-60 .(C-188, slug material) 17,000 curies /629 TBq (C-188, pellet material) 14,000 curies /518 TBq J (C-306) 8,500 curies /314.5 TBq LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (M) Gamma Irradiator, Category IV CUSTOM-SOURQ_E1, R YES X NO 9812230175 981221 !
PDR RC
- S8D PDR -
I'I99/2 2 3 0 / ?S
2 - _ . __ _ _. ._ _.-. ._ ._ _ _ _ _ _ _ _
1 l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l (AMENDED IN ITS ENTIRETY) l NO,: NR-220-S-103-S DATE: DEC2I1999 PAGE 2 OF 8 SOURCE TYPE: Gamma Irradiator Source DESCRIPTION: l
.The Models C-188 and C-306 are doubly encapsulated fusion welded sources consisting of one or two inner capsules and an outer capsule. The outer capsule is the same for each source model except for the length. The inner capsules vary according to the type and activity required. l I
The Model C-188 contains one or two inner capsules in various combinations according to type as shown in the table below:
C-188 Tvoe Model Number C-188 Tyne Model Number Number Of Inner (s) Number Of Inner (s) 1- C-177/C-177 7 C-177/AC-191 2 AC-191/AC-191 8 C-177/AC-195 3 AC-195/AC-195 9 C-177/AC-339 4 C-246' 10 AC-191/AC-195 i 5 AC-339/AC-339 11 AC-191/AC-339 l 6 AC-345/C-348 12 AC-195/AC-339 The inner capsules vary according to the user requirements. The I Model C-188 outer encapsulation is constructed of 316L stainless I steel having dimensions as shown: )
. Max. Nominal Min.
(inch) (mm) (inch) (mm) (inch) (mm)
Overall length 17.9 454.7 17.8 452.1 17.7 449.6 Outside dia. at and caps 0.50 12.7 0.44 11.2 0.40 10.2 Outside dia. of body 0.40 10.2 0.38 9.7 0.37 9.4 Wall thickness of body 0.027 0.69 0.026 0.63 0.023 0.58 The end cap is attached to the main body using a fusion weld.
Selection of the inner capsule /s varies according to user
. requirements in a configuration as shown above for Type Number 1 through 12. The fit of overall diameter and length dimensions l between the inner and outer capsules is within the range of a minimum diametrical clearance 0.003 inches (0.076 mm) and a p minimma length clearance of 0.06 inches (1.5 mm) respectively.
I The Model C-306 outer capsule is the same for all types. The inner capsule varies according to the user requirements. The
j REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.- NR-220-S-103-S DATE: OIC 2 I INO PAGE 3 OF 8 SOURCE TYPE: Gamma Irradiator Source
, DESCRIPTION (cont'd):
Model C-306, Type 1 source contains one Model C-339 inner capsule; the Type 2 contains one C-177 inner capsule. Prior to the effective date of this registration certificate, the Model C-306, Type 1 i
source contained one Model AC-195 inner capsule, Type 2 contained one AC-191, and Type 3 contained one C-177 inner capsule.
The Model C-306 outer encapsulation is constructed of 316L stainless
. steel having dimensions as shown:
1 Max. Nominal Min.
i (inch) (mm) (inch) (mm) (inch) (mm)
Overall length 9.6 243.9 9.5 241.3 9.4 238.8 Outside dia. at end caps 0.50 12.7 0.44 11.2 0.40 10.2
- Outside dia, of body 0.40 10.2 0.38 9.7 0.37 9.4
. Wall thickness of body 0.027 0.69 0.026 0.63 0.023 0.58 The end cap is attached to the main body using a fusion weld.
)' Selection of the inner capsule varies according to user requirements; i.e. either Type 1 or Type 2 configuration. The fit of overall diameter and length dimensions between the inner and outer capsules is within the range of a minimum diametrical clearance 0.003 inches (0.076 mm) and a minimum length clearance of 0.06 inches (1.5 mm) respectively.
The inner capsules have a maximum outside diameter of 0.32 fnches (8.13 mm) and a wall thickness of 0.025 inches (0.64 mm). The length of the inner capsules, the capsule material, and the radioactive source contents vary for each model as shown below:
Model No. Radioactive Capsule Max. lancrth of Inner Contents Material (inch) (mm)
C-246 pellets or slugs SS316L 16.6 422 AC-339 pellets or slugs Zircaloy 2/4 8.3 211 C-177 pellets or slugs SS316L 8.3 211 AC-191 pellets or slugs SS316L 8.3 211 AC-195 pellets or slugs Zircaloy 2 8.3 211 AC-345 slugs Zircaloy 2/4 11.3 287 C-348 slugs SS316L 5.3 134
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l NO.: NR-220-S-103-S DATE: D[C211998 PAGE 4 OF 8 l l
SOURCE TYPE: Gamma Irradiator Source DESCRIPTION (cont'd):
The source material-in the inner capsules is either 0.039 inches (0.99 mm) long by 0.039 inches (0.99 mm) diameter nickel plated cobalt pellets, or 0.25 inches (6.35 mm) diameter nickel plated j slugs. The length of the slugs varies in increments of 0.5 inches (12.7 mm) up to 3.0 inches (76.2 mm) long.
The majority of sources contain slug material as active contents.
Occasionally, for low activity or sources requiring close tolerance dose outputs, material in pellet form is used as the active contents. The use of. pellets makes it possible to mix pellets of various activities along with inactive pellets to accurately obtain required dose outputs. The pellets are of metallic form and nickel plated and, thus, indispersible in water.
LABELING 1 I Each model of the inner capsule assemblies is engraved on the end capsule with a serial number except the Model C-246 which is engraved on the body. ;
The Model C-188 and C-306 sources are engraved in the following manner:
- a unique serial number on the upper end cap face; e either "C-188" or"C-306" and "Co 60" on the upper end cap diameter;
- the radiation trefoil and "MDSN X" (where MDSN is the designation of manufacturer, MDS Nordion,Inc., and X is the material heat number) un the lower end cap diameter. Sources manufactured under the earlier names of the company had been engraved correspondingly as "AECL" or "NII X."
DIAGRAM:
See Attachments 1 and 2.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO,; NR-220-S-103-S DATE: DEC 211936 PAGE 5 OF 8 SOURCE TYPE: Gamma Irradiator Source CONDITIONS OF NORMAL USE:
The source Models C-188 and C-306 sources are designed primarily for use in wet source storage, pool type irradiators. Typical environments associated with the use of these irradiators include high temperatures, thermal shock due to sources'being brought out of and into the water, and long term contact with water.
The sources may be used in dry source storage irradiators and environments for these devices would typically be less harsh.
These uses would typically be medical facilities and laboratories fit for human occupancy. Therefore, the sources would be expected to be subjected to ambient temperatures and pressures, i However, high activity sources may be' exposed to elevated I temperatures and temperature cycling due to internally generated
]
heat.
PROTOTYPE TESTING:
l The manufacturer conducted ANSI classification tests in order to classify the Model C-188-source. Category IV iradiators must have !
a minimum classification of E53424 to meet the requirements of 10 )
CFR 36.21 and ANSI N43.6. The Model C-188 source was successfully l tested to E65646 in accordance with ANSI N542-1977, " Sealed Radioactive Sources, Classification." The tests were conducted l by using dummy slug material rather than pellet material, because I the slug configuration represented the more severe conditions.
The manufacturer conducted an additional bend test, as specified ,
in ANSI N43.10, " Safe design and Use of Panoramic Wet Source i Storage gamma Irradiators." In the bend test, the Model C-188 source performed to class 5.
l The manufacturer claims that the Model C-306, Types 1 and 2, L
capsule meet the standards of ANSI classification E54434 based on i comparison with the Model C-188 capsule. l i
1 EXTERNAL RADIATION LEVELS:
l A-calculation'of dose rates was done using the gamma radiation constant for cobalt-60 of 1.32 R/hr (13.2 mSv/hr) at one meter, per curie (39.4 in., per 37 GBq). A source containing 17,000 curies would be expected to yield the following dose rates:
i l
l l
i
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO,: NR-220-S-103-S DATE: DEC 2 l iggg PAGE 6 OF 8 SOURCE TYPE: Gamma Irradiator Source l
l EXTERNAL RADIATION L:EVELS (cont'd):
Distance Radiation Level I from source R/hr Sv/hr 100 cm/39.4 in 22,000 220 30 cm/11.8 in 250,000 2,500
- 5 cm/1.97 in 9,000,000 90,000 -l A source containing 14,000 curies would be expected to yield the following dose rates
Distance' Radiation Level from source R/hr Sv/hr l- 100 cm/39.4 in 18,500 185 30 cm/11.8 in 205,000 2,050
- 5 cm/1.97 in 7,400,000 74,000 L A source containing 8;500 curies would be expected to yield the
- following dose rates
l l
Distance Radiation Level l from source R/hr Sv/hr 100 cm/39.4 in 11,000 110 30 cm/11.8 in 125,000 1,250 5 cm/1.97 in 4,500,000 45,000 OUALITY ASSURANCE AND CONTROL:
MDS Nordion, Inc. (formerly AECL and Nordion International, Inc.)
maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the program is on file.with the NRC.
l LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The sources shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
- REVIEWER NOTE: These sources may be used in dry source storage irradiators. Sources used in these devices shall be
__ _ _ _ _ ..m _. . _ . . . _ _ . _ -_._._ _____ ._ _____ _
' REGISTRY OF' RADIOACTIVE SEALED SOURCES ~AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN'ITS ENTIRETY)
NO,: NR-220'-S-103-S lpKEl E 211998. PAGE 7 OF 8 SOURCE TYPE: - Gamma'Irradiator Source ,
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont'd): T leak tested at' intervals not to exceed six months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
REVIEWER NOTE: Sources used in wet source storage irradiators l shall be tested for contamination according to Section 36.59, !
10'CFR Part 36, oJ
- Handling, storage, use, transfer, and disposal: To be determined by'the licensing authority. In view that the sealed sources exhibit high surface dose rates when unshielded, they should be handled only by experienced licensed personnel using adequate remote handling equipment and procedur'es.
- These sources shall not be subjected to environmental or other conditions of use which would exceed an ANSI N542-1977 Classification of 7754434.
- 'This registration sheet and the information contained within the references 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, including the claimed ANSI classification, we continue to conclude that the Model C-188 and C-306 source designs are acceptable for licensing purposes.
-Furthermore, we continue to conclude that the Model C-188 and C306 sources would be expected to maintain their containment integrity for normal conditions of use and accidental conditions which might occur during the uses specified in this certificate.
i,
{i i
L
i.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES-SAFETY EVALUATION OF SEALED SOURCE l (AMENDED IN ITS ENTIRETY)
NO.* NR-220-S-103-S DATE: g[g211998' PAGE 8 OF 8 i
SOURCE TYPE: Gamma Irradiator Source REFERENCES 1 I
l The following supporting documents'for the Models C-188 and C-306 sources are hereby incorporated by reference and are made a part i of this registry document.
l
- Atomic Energy'of Canada, Ltd. letters dated October 29, 1973, June 14, 1974, September 20, 1984,-and July 18, 1985 with enclosures thereto.
- Nordion Inturnational, Inc. letters dated June 25,.1993, March 16, 1992, December 5, 1991, and October 3, 1988, with enclosures thereto, and letter received November 18, 1991, j with enclosures thereto.
l l
- MDS Nordion, Inc. letters dated January 13, 1998, February 16, 1998, and April 3, 1998, with enclosures thereto.
ISSUING AGENCY:
/
l U.S. Nuclear Regulatory Commission DEC 211930
/
/
Date: Reviewer: .
6f 3ohn . Lubinski Date: Concurrence: . W 4teven L.'Baggett f
l
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l NO.: NR-220-S-103-S DATE Attachment 1 E 2 1 1998 10 C 188 Type Model Number ,
l Number of inners '
/ 1 N 3. AC-195/AC195 Cc60 4. C-246 INACTIVE FUSION WELD
, 5. AC-339/AC-339 h ;
OUTER CAPSULE:
- 6. AC 345/AC-348 s [gg e--
4 '
O.38 in. O.D. x 0.025 in. wall 7. C-177/AC-191
' (9.7 mm x 0.64 mm)
E__ __ 8.
' C-177/AC-195
' s d
' i,
- 9. C-177/AC 339
'; % , 10. AC 191/AC-195
- " l
- 11. AC 191/AC-339
- 12. AC 195/AC 339
, INNER CAPSULES n n, *
-w '
Notes n8
- 1. Conforms to IAEA Special Form requirements
!"Mm RADIOACTIVE MATERIAL p - AECB Certificate No. CON /0010/S.
d '
g
- 2. Radioactive Material: Cobalt 40 in solid form.
, 3. Outer capsule material: Type 316L stainless steet
's
- 4. All casules are sealed by fusion Walds.
d t A* ' 5. Engraved on capsule:
st
- ~ " (A) Upper end cap (face; serial number (diameter): C-188 Co60
- "I ,
(B) Lower end cap (diameter): MDSN X and Trefoil s ,
r ,. where X is matertal heat number.
g b s >
. ACTIVE FUSION WELD h #
cg
- n. n m ,
ijsiIllS!
q END CAP T
9'T
\ /
Model C-188 Series Irradiator Source Assembly
)
REGISTRY OF RADIOACTIVE SEALED' SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIP".TY)
NO,: NR-220-S-103-S DATE: DEC 211988 Attachment 2 e u _.
1 I
l Co 60 : end Cap
- : Inactive Fusion Weld I
- Outer Capsule 0.38 in. 0.0. x 0.025 in. wall (9.7 mm x 0.64 mm)
Inner Capsule
..J c- ) , Type No, inner Capsule Qty
- 1. C 339 1
- 2. C 177 1 c . h,
. A,.
,==
Notes Active FusionWeld
- 1. Radioactive Material: Cobalt-60 in solid form.
l 9 : End Cap 2. Outer capsule material: Type 316L stainless steel l'
T*f 3. All casules are sealed by fusion welds.
.. 4. Engraved on capsule:
(A) Upper end cap (face: serial number
[< (diameter): C-306 Co60 (B) Lower end cap (diameter): MDSN X and Trefoil l4 where X is material heat number.
l l
Model C-306 Series Irradiator Source Assembly.
i l
l
December 21, 1998 Mr. Ronald McGregor l Manager, Regulatory Affairs MDS Nordion, Inc.
447 March Road l
Kanata, Ontario, Canada K2K 1X8
Dear Mr. McGregor:
Based on the information and test data submitted in your application dated February 4,1997, and subsequent correspondance, we conclude that the Model C-188 and Model C-306 sealed sources l are acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-220-S-103-S).
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the j 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 certificate.
Pleato read over the registration certificate in its entirey and notify us immediately of any errors or omissions.
l You are obligated to notify us promptly in writing should you decide to no longer manufacture or l offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing 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) 415-6096.
If you have any questions, please contact me at (301) 415-7904 or Mr. Steven Baggett at (301) 415-7273.
Sincerely,
/s/
John P. Jankovich, Ph.D., Sr. Engineer Materials 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: j IMNS r/f SSD-98-31 NE01 O SSD File # NR-220-S-103-S DOCUMENT NAME: H:\SSDFILES\ LETTERS \NR220103.COM To receive a copy of this document, indicate in the bos: *C* = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N*
= No copy OFFICE IMNS ,y c, IMNS s / l IMNS g lv NAME JJankovich/jj d irf JLubiNpti SBaggett (t\@
DATE M796 g/Lfg/(/g 6/ ,/pBN S7S t((fqd
' ' l OFFICIAL R(COR] COPY
l*
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-220-S-103-S DATE: DEC 211938 PAGE 1 OF 8 SOURCE TYPE: Gamma Irradiator Source l l
, MODEL: C-188 (Series) Types 1 - 12 C-306 (Series) Types 1 - 3 l
MANUFACTURER / DISTRIBUTOR: MDS Nordion, Inc.
(formerly Atomic Energy of Canada, Ltd. and Nordion International, Inc.)
447 March Road Kanata, Ontario, Canada K2K 1X8 4
ISOTOPE: MAXIMUM ACTIVITY:
Cobalt-60 (C-188, slug material) 17,000 curies /629 TBq (C-188, pellet material) 14,000 curies /518 TBq (C-306) l 8,500 curies /314.5 TBq LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (M) Gamma Irradiator, Category IV l
CUSTOM-SOURCE: YES X NO
{}A50f9F l0 fj9
- . . - . . - _ . . - _ . ~ . .- . - . . . . . . - . _ . ~ - . _ - . .. - . _ - . - . . - -
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.- NR-220-S-103-S DtTE: DiC 2 I 1998 PAGE 2 OF 8 SOURCE TYPE: Gamma Irradiator Source DESCRIPTION _L The Models C-188 and C-306 are doubly encapsulated fusion welded sources consisting of one or two inner capsules and an outer capsule. The outer capsule is the same for each source model ercept for the length. The inner capsules vary according to the type and activity required.
The Model C-188 contains one or two inner capsules in various combinations according to type as shown in the table below:
1 C-188 Tvoe Model Number C-188 Tvoe Ffodel Number l
Number Of Inner (s) Number Of Inner (s) ;
1 C-177/C-177 7 C-177/AC-191 2 AC-191/AC-191 8 C-177/AC-195 3 AC-195/AC-195 9 C-177/AC-339
, 4 C-246 10 AC-191/AC-195 5 AC-339/AC-339 11 AC-191/AC-339 6 AC-345/C-348 12 AC-195/AC-339 i
The inner capsules vary according to the user requirements. The i Model C-188 outer encapsulation is constructed of 316L stainless steel having dimensions as shown:
Max. Nominal Min.
(inch) (mm) (inch) (mm) (inch) (nm)
Overall length 17.9 454.7 17.8 452.1 17.7 449.6 Outside dia. at end caps 0.50 12.7 0.44 11.2 0.40 10.2 Outside dia. of body 0.40 10.2 0.38 9.7 0.37 9.4 Wall thickness of body 0.027 0.69 0.026 0.63 0.023 0.58 The end cap is attached to the main body using a fusion weld.
Selection of the inner capsule /s varies according to user requirements in a configuration as shown above for Type Number 1 through 12. The fit of overall diameter and length dimensions between the inner and outer capsules is within the range of a minimum diametrical clearance 0.003 inches (0.076 mm) and a minimum length clearance of 0.06 inches (1.5 mm) respectively.
The Model C-306 outer capsule is the same for all types. The inner capsule varies according to the user requirements. The 4
.e -.4 - -. + - - . - ,.m-y-i m-
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.- .NR-220 S-103-S DATE: NC2 INN PAGE 3 OF 8 SOURCE TYPE: Gamma Irradiator Source DESCRIPTION (cont'd):
Model C-306, Type 1 source contains one Model C-339 inner capsule; the Type 2 contains one C-177 inner capsule, Prior to the effective date of this registration certificate, the Model C-306, Type 1 source contained one Model AC-195 inner capsule, Type 2 contained one AC-191, and Type 3 contained one C-177 inner capsule.
The Model C-306 outer encapsulation is constructed of 316L stainless steel having dimensions as shown:
Max. Nominal Min.
(inch) (mm) (inch) (mm) (inch) (mm) ,
Overall length 9.6 243.9 9.5 241.3 9.4 238.8 Outside dia. at end caps 0.50 12.7 0.44 11.2 0.40 10.2 l Outside dia. of body 0.40 10.2 0.38 9.7 0.37 9.4 Wall thickness of body 0.027 0.69 0.026 0.63 0.023 0.58 The end cap is attached to the main body using a fusion weld.
Selection of the inner capsule varies according to user requirements; i.e. either Type 1 or Type 2 configuration. The fit of overall diameter and length dimensions between the inner and outer capsules is within the range of a minimum diametrical clearance 0.003 inches (0.076 mm) and a minimum length clearance of 0.06 inches (1.5 mm) respectively.
The inner capsules have a maximum outside diameter of 0.32 inches (8.13 mm) and a wall thickness of 0.025 inches (0.64 mm). The length of the inner capsules, the capsule material, and the radioactive source contents vary for each model as shown below:
Model No. Radioactive Capsule Max. lenath of Inner Contents Material (inch) Unni C-246 pellets or slugs SS316L 16.6 422 AC-339 pellets or slugs Zircaloy 2/4 8.3 211 C-177 pellets or slugs SS316L 8.3 211 ,
AC-191 pellets or slugs SS316L 8.3 211 AC-195 pellets or slugs Zircaloy 2 8.3 211 AC-345 slugs Zircaloy 2/4 11.3 287 C-348 slugs SS316L 5.3 134 l -
- . - . - . - _ - - . - - - . . . . - - . ~ . - - - . . - . . . - . - - . . . . - - - - . - . . - - .
- i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i SAFETY EVALUATION OF SEALED SOURCE
- (AMENDED IN ITS ENTIRETY) l NO. NR-220-S-103-S DATE
- D[C;11338 PAGE 4 OF 8
~
l . SOURCE TYPE: Gamma Irradiator Source i
DESCRIPTION (cont'd):
j The source material in the inner capsules is either 0.039 inches (0.99.mm) long by 0.039 inches (0.99 mm) diameter nickel plated cobalt pellets, or 0.25 inches (6.35 mm) diameter nickel plated slugs. The length of the slugs varies in increments of 0.5 inches (12.7 mm) up to 3.0 inches (76.2 mm) long.
The majority of sources contain slug material as active contents.
Occasionally, for-low activity or sources requiring close tolerance dose outputs, material in pellet form is used as the active contents. The use of. pellets makes it possible to mix pellets of various activities along with inactive pellets to accurately obtain required dose outputs. The pellets are of metallic form and nickel plated and, thus, indispersible in water.
LABELING:
Each model of the inner capsule assemblies is engraved on the end capsule with a serial number except the Model C-246 which is engraved on the body.
The Model C-188 and C-306 sources are engraved in the following manners
- a unique serial number on the upper end cap face;
- either "C-188" or"C-306" and "Co 60" on the upper end cap diameter; the radiation trefoil and "MDSN X" (where MDSN is the designation of manufacturer, MDS Nordion,Inc., and X is the material heat number) on the lower end cap diameter. Sources manufactured under the earlier names of the company had-been engraved correspondingly as "AECL" or "NII X."
DIAGRAM:
See Attachments 1 and 2.
4 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES j SAFETY EVALUATION OF SEALED SOURCE )
(AMENDED IN ITS ENTIRETY) i l
l NO.- NR-220-S-103-S DATE: D(C211393 PAGE 5 OF 8 l l
l SOURCE TYPE: Gamma Irradiator Source l l
CONDITIONS OF NORMAL USE:
The source Models C-188 and C-306 sources are designed primarily I for use in wet source storage, pool type irradiators. Typical l environments associated with the use of these irradiators include high temperatures, thermal shock due to sources being brought out of and into the water, and long term contact with water.
The sources may be used in dry source storage irradiators and environments for these devices would typically be less harsh.
l These uses would typically be medical facilities and laboratories I
fit for human occupancy. Therefore, the sources would be expected to be subjected to ambient temperatures and pressures.
However, high activity' sources may be exposed to elevated l temperatures and temperature cycling due to internally generated heat.
PROTOTYPE TESTING:
1 l
The manufacturer conducted ANSI classification tests in order to classify the Model C-188 source. Category IV iradiators must have a minimum classification of E53424 to meet the requirements of 10 CFR 36.21 and ANSI N43.6. The Model C-188 source was successfully tested to E65646 in accordance with ANSI N542-1977, " Sealed Radioactive Sources, Classification." The tests were conducted by using dummy slug material rather than pellet material, because the slug configuration represented the more severe conditions.
- The manufacturer conducted an additional bend test, as specified in ANSI N43.10, " Safe design and Use of Panoramic Wet Source Storage gamma Irradiators." In the bend test, the Model C-188 source performed to Class 5.
The manufacturer claims that the Model C-306, Types 1 and 2, capsule meet the standards of ANSI classification E54434 based on comparison with the Model C-188 capsule.
EXTERNAL RADIATION LEVELS:
A calculation of dose rates was done using the gamma radiation constant for cobalt-60 of 1.32 R/hr (13.2 mSv/hr) at one meter, per curie (39.4 in., per 37 GBq). A source containing 17,000 curies would be expected to yield the following dose rates:
_.__.m. . . - _ . _ .-_ _ - . _ _ _ _ _ _ _ _ . . - . _ _ . . _
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.- NR-220-S-103-S DATE: D H 2 g 1938 PAGE 6 OF 8 SOURCE TYPE: Gamma Irradiator Source EXTERNAL RADIATION L:EVELS (cont'd)-
Distance Radiation Level from source R/hr Sv/hr 100 cm/39.4 in 22,000 220 30 cm/11.8 in 250,000 2,500 5 cm/1.97 in 9,000,000 90,000 A source containing 14,000 curies would be expected to yield the following dose rates:
Distance Radiation Level from source R/hr Sv/hr 100 cm/39.4 in 18,500 185 30 cm/11.8 in 205,000 2,050
, 5 cm/i.97 in 7,400,000 74,000.
A source containing 8,500 curies would be expected to yield the following dose rates:
Distance Radiation Level from source R/hr Sv/hr l 100 cm/39.4 in 11,000 110 j- 30 cm/11.8 in 125,000 1,250 l- 5 cm/1.97 in 4,500,000 45,000 l
l OUALITY ASSURANCE AND CONTROL:
MDS Nordion, Inc. (formerly AECL and Nordion International, Inc.)
maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the
-program is on file with the NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
i.
- The sources shall be distributed only to persons i specifically licensed by the NRC or an Agreement State.
- REVIEWER NOTE: These sources may be used in dry source storage irradiators. Sources used in these devices shall be i
. . .. - - - . . - - - - . =- _ . ,
i l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l NO.- NR-220-S-103-S DATE: gg 711gg8 PAGE 7 OF 8 SOURCE TYPE: Gamma Irradiator Source l
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont'd)- l leak tested at intervals not to exceed six months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
REVIEWER NOTE: Sources used in wet source storage irradiators shall be tested for contamination according to Section 36.59, 10 CFR Part 36.
Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. In view that the sealed sources exhibit high surface dose rates when unshielded, they should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures.
These sources shall not be subjected to environmental or other conditions of use which would exceed an ANSI N542-1977 Classification of 7754434.
- This registration sheet and the information contained within the references 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, including the claimed ANSI classification, we continue to conclude that the Model C-188 and C-306 source designs are acceptable for licensing purposes.
Furthermore, we continue to conclude that the Model C-188 and C306 sources would be expected to maintain their containment integrity for normal conditions of use and accidental conditions which might occur during the uses specified in this certificate.
i
l l*
t REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
'NO.- NR-220-S-103-S DATE: g[t 2 ) 1998 PAGE 8 OF 8 SOURCE TYPE: Gamma Irradiator Source
REFERENCES:
l l
The following supporting documents for the Models C-188 and C-306 l
sources are hereby incorporated by reference and are made a part of this registry document.
l
- Atomic Energy of Canada, Ltd. letters dated October 29, 1973, l June 14, 1974, September 20, 1984, and July 18, 1985 with enclosures thereto.
)
- Nordion International, Inc. letters dated June 25, 1993, March 16, 1992, December 5, 1991, and October 3, 1988, with enclosures thereto, and letter received November 18, 1991, i 1 with enclosures thereto. l l.
- MDS Nordion, Inc. letters dated January 13, 1998, February 16, 1998, and April 3, 1998, with enc]osures thereto.
ISSUING AGENCY:
/
U.S. Nuclear Regulatory Commission /
l- g[t 211998 c /
Date: Reviewer: 1 6f Dohn '
. Lubinski DEC 211898
- Date: Concurrence: . ( .33' 4teven L.'Baggett I-L l'
i r
. - - - . .. - - - - .~ ~ . . .- . - . - - _ _
- c
'O REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-220-S-103-S DATE: Attachment 1 E 2 1 1990 l
l 10 C 188 Type Model Number i
Nurr.ber of Inners
- 5. AC-339/AC-339 I$ M' i OUTER CAPSULE:
- 6. AC-345/AC-348 l
i s
e
[ -
O.38 in. O D. x 0.025 in. wall 7. C-177/AC 191
' ' (9.7 mm x 0.64 mm)
L_.._) -
- 8. C-177/AC-195 l , ,
l ' s l 9. C-177/AC-339 s
- i,
%N ,
- 10. AC-191/AC-195 I , 11. AC 191/AC-339
, 12. AC-195/AC-339 l
, INNER CAPSULES p -
4 - _
, e Notes
- 1. Conforms to lAEA Spedal Form requirements 5lM,
- p '
p RADIOACTIVE MATERIAL AECD Certificate No. CDN/0010/S.
- 2. Radioactive Material: Cobalt 40 in sold form.
q
- 3. Outer capsule material: Type 316L stainless steel, e s.
- 4. All casules are sealed by fusion welds.
A* "
8 ' 5. Engraved on capsule:
_ _ , (A) Upper end cap (face: serial number s t
- s ,
(diameter): C 188 Co60 (B) Lower end cap (diameter): MDSN X and Trefoil
- "I l where X is material heat number.
8 e
! t k P
, i s
!l i
M d I d ACTIVE FUSION VELD l )Ess5$$ i i p 5f Y_M_Iq END CAP 1
I T
9'T
\ /
Model C-188 Series Irradiator Source Assembly
- - . ~ , - - . - - - . - - . . - . - - . . . . - - - - . . . - . . - . ..
i
\6.
I i
l 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-220-S-103-S DATE: DEC 211998 Attachment 2 .
l
@ l Co 60 : End Cap
- Inactive Fusion Weld c:
i e Outer Capsule 0.38 in. O.D. x 0.025 in. wall l (9.7 mm x 0.64 mm) l' i- Inner Capsule
.a L r
l{ , Type No. Inner Capsule Qty
- 1. C-339 1 l 2. C-177 1 l
1
, q A-- ,
l I
i c== Notes Active Fusion Weld I
I 1. Radioactive Material: Cobalt-60 in solid form.
T : End Cap 2 Outer capsule material: Type 316L stainless steel.
l T*f 3. Allcasules are sealed by fusion welds.
- 4. Engraved on capsule:
l i
(A) Upper end cap (face; serial number
- l. (diameter): C-306 Cc60 l (B) Lower end cap (diameter): MDSN X and TrefoR where X is metonal heat number.
_ . _ , _ . . - . ...e...~,- ,-_.._,,.,.m,m%,.. ,
l~
Model C-306 Series Irradiator Source Assembly
December 21, 1998 Mr. Ronald McGregor Manager, Regulatory Affairs MDS Nordion, Inc.
447 March Road Kanata, Ontario, Canada K2K 1X8
Dear Mr. McGregor:
Based on the information and test data submitted in your application dated February 16,1997, and subsequent correspondance, we conclude that the Model C-188 and Model C-306 sealed sources are acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-220-S-103-S).
Please be advised that you must manufacture and distribute tF 2 product in accordance with the statements and representations contained in your application, with enclosures thereto, and the 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 certificate.
Please read over the registration cert;ficate in its entirety and notify us immediately of any errors or omissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing 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) 415-6096.
If you have any questions, please contact me at (301) 415-7904 or Mr. Steven Baggett at (301) 415-7273.
Sincerely,
/s/
John P. Jankovich, Ph.D., Sr. Engineer Materials 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: j f IMNS r/f SSD-98-31 NE01 JV SSD File # NR-220-S-103-S DOCUMENT NAME: H:\SSDFILES\ LETTERS \NR220103.COM To ressive a copy of this documeen, Indicate in the box: "C" = Copy without attachment / enclosure "E' = Copy with attachment / enclosure 'N'
= No copy
" OFFICE IMNS im C, IMt{S / l lMNS g U l NAME JJankovich/jj /l lrff JLubbs)ti SBaggett (Hpb DATE /sQL9% yJfiffq) 6! JyBN S: lDS- t ffffq$
l OFFICIAL R(CORD COPY 0
-l & 3-Of(r f ~ } 7
. - . . , .._ .-. . _ _ - . _ .- . _ _ _ . _ _ _ . _ . _ . . _ . _ _ _ _ _ _ _ _ . . _ . _ _ . _ . _ _ . ~ . . _ _ _ _ . . . _ _ _ .
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO : NR-220-S-103-S DATE: D[C211998 PAGE 1 OF 8 SOURCE TYPE: Gamma Irradiator Source MODEL:. C-188 (Series) Types 1 - 12 C-306 (Series) Types 1 - 3 MANUFACTURER / DISTRIBUTOR: MDS Nordion, Inc.
(formerly Atomic Energy of Canada, Ltd. and Nordion International, Inc.)
447 March Road Kanata, Ontario, Canada K2K 1X8.
ISOTOPE: MAXIMUM ACTIVITY:
Cobalt-60 (C-188, slug material) 17,000 curies /629 TBq (C-188, pellet material) 14,000 curies /518 TBq (C-306) 8,500 curies /314.5 TBq LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (M) Gamma Irradiator, Category IV i
CUSTOM-SO'URCE: YES X NO m
I-L i
.QW+92MiW } Oyp
- - -. . - . - - . _ . _ . ~. . . . - . . .-- _ - - . - ._. - . -
l l-1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
L NO.- NR-220-S-103-S DATE: DEC 211998 PAGE 2 OF 8 SOURCE TYPE: Gamma Irradiator Source DESCRIPTION:
The Models C-188 and C-306 are doubly encapsulated fusion welded sources consisting of one or two inner capsules and an outer l capsule. The outer capsule is the same for each source model !
except for the length. The inner capsules vary according to the type and activity required. )
The Model C-188 contains one or two inner capsules in various combinations according to type as shown in the table below:
C-188 Tvoe Model Number C-188 Tvoe Model Number Number Of Inner (s) Number Of Inner (s) l 1 C-177/C-177 7 C-177/AC-191 2 AC-191/AC-191 8 C-177/AC-195 3 AC-195/AC-195 9 C-177/AC-339 4 C-246 10 AC-191/AC-195 5 AC-339/AC-339 11 AC-191/AC-339 6 AC-345/C-348 12 AC-195/AC-339 The inner capsules vary according to the user requirements. The Model C-188 outer encapsulation is constructed of 316L stainless steel having dimensions as shown:
Max. Nominal Min.
(inch) (mm) (inch) (mm) (inch) (mm)
Overall length 17.9 454.7 17.8 452.1 17.7 449.6
-Outside dia. at and caps 0.50 12.7 0.44 11.2 0.40 10.2 Outside dia. of body 0.40 10.2 0.38 9.7 0.37 9.4 Wall thickness of body 0.027 0.69 0.026 0.63 0.023 0.58 The end cap is attached to the main body using a fusion weld.
Selection of the inner capsule /s varies according to user requirements in a configuration as shown above for Type Number 1 through 12. The fit of overall diameter and length dimensions l between the inner and outer capsules is within the range of a l minimum diametrical clearance 0.003 inches (0.076 mm) and a minimum length clearance of 0.06 inches (1.5 mm) respectively.
The Model C-306 outer capsule is the same for all types. The l inner capsule varies according to the user requirements. The
-~
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.- NR-220-S-103-S DATE: E2IO PAGE 3 OF 8
! SOURCE TYPE: Gamma Irradiator Source DESCRIPTION (cont'd)-
l Model C-306, Type 1 source contains one Model C-339 inner capsule; the Type 2 contains one C-177 inner capsule. Prior to the effective date of this registration certificate, the Model C-306, Type 1 source contained one Model AC-195 inner capsule, Type 2 contained
. one AC-191, and Type 3 contained one C-177 inner capsule.
The Model C-306 outer encapsulation is constructed of 316L stainless I
steel having dimensions as shown:
l Max. Nominal Min.
(inch) (mm) (inch) (mm) (inch) (mm) l
! Overall length 9.6 243.9 9.5 241.3 9.4 238.8 Outside dia. at and caps 0.50 12.7 0.44 11.2 0.40 10.2 Outside dia. of body 0.40 10.2 0.38 9.7 0.37 9.4 Wall thickness of body 0.027 0.69 0.026 0.63 0.023 0.58 The end cap is attached to the main body using a fusion weld.
- Selection of the inner capsule varies according to user
! requirements; i.e. either Type 1 or Type 2 configuration. The fit of overall diameter and length dimensions between the inner and outer capsules is within the range of a minimum diametrical clearance 0.003 inches (0.076 nua) and a minimum length clearance of 0.06 inches (1.5 nun) respectively.
The inner capsules have a maximum outside diameter of 0.32 inches (8.13 nsa) and a wall thickness of 0.025 inches (0.64 num). The length of the inner capsules, the capsule material, and the l
rsdioactive source contents vary for each model as shown below:
l
- l. Model No. Radioactive Capsule Max. lenath
! of Inner Contents Material (inch) (mm) l C-246 pellets or slugs SS316L 16.6 422 AC-339 pellets or slugs Zircaloy 7/4 8.3 211
{ C-177 pellets or slugs SS316L 8.3 211 AC-191 pellets or slugs SS316L 8.3 211 I AC-195 pellets or slugs Zircaloy 2 8.3 211 4 AC-345 slugs 'Zircaloy 2/4 11.3 287 C-348 slugs SS316L 5.3 134
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-220-S-103-S DATE: D[C?11338 PAGE 4 OF 8 )
l SOURCE TYPE: Gamma Irradiator Source l DESCRIPTION (cont'd):
The source material in the inner capsules is either 0.039 inches (0.99 mm) long by 0.039 inches (0.99 mm) diameter nickel plated cobalt pellets, or 0.25 inches (6.35 mm) diameter nickel plated slugs. The length of the slugs varies in increments of 0.5 inches (12.'7 mm) up to 3.0 inches (76.2 mm) long.
The majority of sources contain slug material as active contents.
Occasionally, for low activity or sources requiring close tolerance dose outputs, material in pellet form is used as the active contents. The use of pellets makes it possible to mix pellets of various activities along with inactive pellets to accurately obtain required dose outputs. The pellets are of metallic form and nickel plated and, thus, indispersible in water. !
(
LABELING Each model of the inner capsule assemblies is engraved on the end capsule with a serial number except the Model C-246 which is engraved on the body.
The Model C-188 and C-306 sources are engraved in the following manners a a unique serial number on the upper end cap face; I
- either "C-188" or"C-306" and "Co 60" on the upper end cap j diameter; the radiation trefoil and "MDEN X" (where MDSN is the I
designation of manufacturer, MDS Nordion,Inc., and X is the material heat number) on the lower end cap diameter. Sources manufactured under the earlier names of the company had been engraved correspondingly as "AECL" or "NII X."
DIAGRAM:
See Attachments 1 and 2.
I
1 l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) i NO..1 NR-220-S-103-S DATE: O(C 211399 PAG _E 5 OF 8 SOURCE TYPE: Gamma Irradiator Source l l
CONDITIONS OF NORMAL USE: ,
1 The source Models C-188 and C-306 sources are designed primarily for use in wet source storage, pool type irradiators. Typical I environments associated with the use of these irradiators include
! high temperatures, thermal shock due to sources being brought out l of and into the water, and long term contact with water.
The sources may be used in dry source storage irradiators and environments for these devices would typically be less harsh.
l These uses would typically be medical facilities and laboratories i fit for human occupancy. Therefore, the sources would be expected to be subjected to ambient temperatures and pressures. l However, high activity. sources may be exposed to elevated I temperatures and temperature cycling due to internally generated heat.
! PROTOTYPE TESTING:
! The manufacturer conducted ANSI classification tests in order to classify the Model C-188 source. Category IV iradiators must have ]
a minimum classification of E53424 to meet the requirements of 10 .
- CFR 36.21 and ANSI N43.6. The Model C-188 source was successfully tested to E65646 in accordance with ANSI N542-1977, " Sealed Radioactive Sources, Classification." The tests were conducted i
by using dummy slug material rather than pellet material, because i the slug configuration represented the more severe conditions.
i The manufacturer conducted an additional bend test, as specified
- in ANSI N43.10, " Safe design and Use of Panoramic Wet Source f Storage gamma Irradiators." In the bend test, the Model C-188 j source performed to Class 5.
l The manufacturer claims that the Model C-306, Types 1 and 2, capsule meet the standards of ANSI classification E54434 based on comparison with the Model C-188 capsule.
EXTERNAL RADIATION LEVELS:
l A calculation of dose rates was done tsing the gamma radiation
- - constant for cobalt-60 of 1.32 R/hr (13.2 mSv/hr) at one meter, per curie (39.4 in. , per 37 GBq) . A source containing 17,000 I curies would be expected to yield the following dose rates
1 l
1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETV)
NO.: NR-220-S-103-S DATE: D H 2 I lggg PAGE 6 OF 8 SOURCE TYPE: Gamma Irradiator Source EXTERNAL RADIATION L;EVELS (cont'd)-
Distance Radiation Level from source RLhr Sv/hr 100 cm/39.4 in 22,000 220 30 cm/11.8 in 250,000 2,500 5 cm/1.97 in 9,000,000 90,000 A source containing 14,000 curies would be expected to yield the following dose rates:
Distance Radiation Level from source R/hr Sv/hr 100 cm/39.4 in 18,500 185 30 cm/11.8 in 205,000 2,050 5 cm/1.97 in 7,400,000 74,000 A source containing 8,500 curies would be expected to yield the following dose rates:
Distance Radiation Level from source R/hr Sv/hr 100 cm/39.4 in 11,000 110 30 cm/11.8 in 125,000 1,250 5 cm/1.97 in 4,500,000 45,000 OUALITY ASSURANCE AND CONTROL:
MDS Nordion, Inc. (formerly AECL and Nordion International, Inc.)
maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the program is on file with the NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The sources shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
REVIEWER NOTE: These sources may be used in dry source storage irradiators. Sources used in these devices shall be t
l
, REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS. ENTIRETY)
NO.: NR-220-S-103-S DATE: Mt 2 g igg 8 PAGE 7 OF 8 SOURCE TYPE: Gamma Irradiator Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont'd)-
leak tested at intervals not to exceed six months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
REVIEWER NOTE: Sources used in "et source storage irradiators shall be tested for contaminat in according to Section 36.59, 10 CFR Part 36.
Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. In view that the sealed sources exhibit high surface dose ratso when unshielded, they should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures.
These sources shall not be subjected to environmental or other conditions of use which would exceed an ANSI-N542-1977 Classification of 7754434.
This registration sheet and the information contained within the references 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, including the claimed ANSI classification, we continue to conclude
'that the Model C-188 and C-306 source designs are acceptable for licensing. purposes.
Furthermore, we-continue to conclude that the Model C-188 and C306 sources would be expected to maintain their containment integrity x for ncrmal conditions of use and accidental conditions which might occur during the uses specified in this certificate.
't
l
.- I I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE !
(AMENDED IN ITS ENTIRETY)
NO.. N9-220-S-103-S DATE: ggt 211998 PAGE 8 OF 8 SOURCE TYPE: Gamma Irradiator Source
REFERENCES:
The following supporting documents for the Models C-188 and C-306 l 1
sources are hereby incorporated by reference and are made a part of this registry document.
Atomic Energy of Canada, Ltd. letters dated October 29, 1973, June 14, 1974, September 20, 1984, and July 18, 1985 with enclosures'thereto.
Nordion International, Inc. letters dated June 25, 1993, March 16, 1992, December 5, 1991, and October 3, 1988, with enclosures thereto, and letter received November 18, 1991, with enclosures thereto.
MDS Nordion, Inc. letters dated January 13, 1998, February 16, 1998, and April 3, 1998, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission f DEC 211998 c /'
Date: Reviewer: 6V John K. Lubinski Date: Concurrence: . t W 4heven L.'Baggett
e I
a l
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l ll NO.: NR-220-S-103-S DATE:
Dit211996 Attachment 1 k
10 C-188 Type Model Number j l Number of inners i
- 1. C-177/C-177 f END CAP 2. AC-191/AC 191
/ I N 3. AC 195/AC195 Co60 INACTIVE FUSION VELD C-24
- 5. AC-339/AC-339 l
- 6. AC-345/AC-348 I, I;' OUTER CAPSULE:
j773 '
k, O.38 in. O D. x 0.025 in. wall 7.
e-- C-177/AC-191
' (9.7 mrr x 0.64 mm) h_ _ , _ _
8.
C-177/AC-195
' a
- 9. C-177/AC-339 s i , l
- g , 10. AC 191/AC-195 8
1
- 11. AC 191/AC-339
- 12. AC-195/AC-339 .
, INNER CAPSULES s n, -- -
]
, Notes j j 1. Conforms to IAEA Spedal Form' requirements
!I RADIOACTIVE MATERIAL
- pD d, AECB Certificate No. CDNAX)10/S.
- 2. Radioactive Material: Cobalt-60 in solid form.
q
- 3. Outer capsule material: Type 316L stainless steel i 3
A, 4. Allcasules are sealed by fusion welds. j d 4 ' 5. Engraved on capsule:
_ _ (A) Upper end cap (face; serial number j s b y ,
(diameter): C-188 Co60 (B) Lower end cap (diameter): MDSN X and Trefoil i
s I ., i where X is material heat number. i e !,
i k I l ,, L l s ACTIVE FUSION WELD
~
h a '
"SMdty ky END CAP T
v*v
\ /
Model C-188 Series Irradiator Source Assembly i
e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-220-S-103-S DATE: DiC 2.11998 Attachment 2 i
Co 60 : End Cap i==
q: Inactive Fusion Weld 5_
- Outer Capsule 0 38 in. O.D. x 0.025 in. wall (9.7 mm x 0 64 mm)
Inner Capsule
_a L r . . Type No. Inner Capsule Qty
- 1. C.339 1
- 2. C-177 1 1 k.
..q L
, : Active Fusion Weld Notes
- I
- 1. Radioactive Material: Cobalt-60 in solid form.
9 : End Cap 2. Outer capsule matertal; Type 316L stainless steel.
T*f 3. All casules are sealed by fusen welds.
4.- Engraved on capsule:
(A) Upper end cap (face: serial number (diameter): C-306 Co60 (B) Lower end cap (diameter): MDSN X and Trefoil where X is metenel heat number.
. ~ . . ,
,1 Model C-306 Series Irradiator Source Assembly l s