ML20247R833
| ML20247R833 | |
| Person / Time | |
|---|---|
| Issue date: | 01/26/1996 |
| From: | Baggett D, Steven Baggett NRC |
| To: | |
| Shared Package | |
| ML20247R838 | List: |
| References | |
| SSD, NUDOCS 9805290225 | |
| Download: ML20247R833 (11) | |
Text
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO,: NR-460-S-906-S DATE: January 26, 1996 FAGE 1 OF 9 SEALED SOURCE TYPE: Tube Source MODEL: Series 6500, 6520 (formerly 6D6C)
MANUFACTURER / DISTRIBUTOR:. 3M Health Physics Service L 3M Center, Building 224-2E-06 St. Paul, MN 55144-1000 l
ISOTOPE: MAXIMUM ACTIVITY:
Cesium-137 500.0 millicuries (18.50 GBq) l (see description for activity per model) i LEAK TEST FREOUENCY: 36 Months PRINCIPAL USE: (V) General Medical Use i.
CUSTOM SOURCE: YES X NO I
9905290225 960126 PDR RC
- SSD PDR m_________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - . _ _ _ - _ _ _ _ _ _ _ __ _ __ _ "_9 U- .9
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE l NO.: NR-460-S-906-S DATE: January 26, 1996 PAGE 2 OF 9 SEALED SOURCE TYPE: Tube Source DESCRIPTION:
The 6500 Series and 6520 Series, together formerly known as the Model 6D6C source, are doubly-encapsulated gamma sources designed for use in brachytherapy applications. The 6500 Series, measuring approximately 0.787 in. (20.00 mm) long and 0.120 in.
(3.050 mm) wide with a 0.551 in. (14.00 mm) active length, was formerly known as the size "CA" capsule of the 6D6C source. The 6520 Series, measuring approximately 0.630 in. (16.00 mm) long and 0.120 in. (3.050 mm) wide with a 0.394 in. (10.00 mm) active length, was formerly known as the size "CC" capsule of the 6D6C source.
Both the 6500 Series and the 6520 Series utilize cesium-137 chloride contained in 3M Brand Radiating Microspheres. The microspheres are small ceramic particles into which the Cs-137 has been absorbed and then permanently fixed using a heat treatment. The microspheres are loaded into an inner capsule.
That inner capsule either has a closed end and is sealed by one 0.043 in. (1.100 mm) stainless steel ball pressed into the open end and welded in place (sources made before 1985), or has two open ends and is sealed by two 0.043 in. (1.100 mm) stainless steel balls, one pressed into each end and welded in place (sources made after 1985).
In either case, the inner capsule is inserted into an outer capsule. A welding plug is then inserted and welded in place.
The outer capsule is either 0.787 in. (20.00 mm) long (for a 6500 Series source) or O.630 in. (16.00 mm) long (for a 6520 Series source). For both Series, the outer capsule has an outer diameter of 0.120 in. (3.050 mm). After welding the outer plug, the entire source is nickel plated.
The outer capsule has an eyelet on one end. That end is also color coded with an epoxy resin to indicate the model number and
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO,: NR-460-S-906-S DATE_:_ January 26, 1996 PAGE 3 OF 9 SEALED SOURCE TYPE: Tube Source DESCRIPTION: (Continued) activity of the source. Examples are given in the chart below:
6500 Series Color Code ma Ra eauiv. Activity of Cs-137 Blue 5 12.5-13.4 mci (462-496 MBq)
Green 10 25.2-27.7 mci (932-1025 MBq)
Yellow 15 37.8-41.6 mci (1.4-1.54 GBq)
Orange 20 50.4-55.4 mci (1.86-2.05 GBq)
Red 25 63-69.3 mci (2.3-2.56 GBq)
Violet 30 75.6-83.2 mci (2.8-3.08 GBq)
White 35 88.2-97 mci (3.26-3.59 GBq)
Black 40 100.8-111 mci (3.73-4.11 GBq) 6520 Series Color Code ma Ra eauivalent Activity of Cs-137 Blue 5 12.5-13.4 mci (462-496 MBq)
Green 10 25.2-27.7 mci (932-1025 MBq)
Yellow 15 37.8-41.6 mci (1.4-1.54 GBq)
Orange 20 50.4-55.4 mci (1.86-2.05 GBq)
Red 25 63-69.3 mci (2.3-2.56 GBq) <
The Cs-137 tube source strengths listed above are " standard" activities. As the sources decay below the nominal activity, however, they fall into a "non-standard" activity category. The strengths of both the " standard" and "non-standard" activity sources are documented in the calibration certificate accompanying the sources at the time of distribution.
The 6500 Series and 6520 Series sources are stored in a lead pig l container when not in use. J l
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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-906-S DATE: January 26, 1996 PAGE 4 OF 9
. SEALED SOURCE TYPE: Tube Source DIAGRAM:
See Attachments 1 (post 1985 sources) and 2 (pre 1985 sources).
LABELING:
3M stated that the outer nickel encapsulation is engraved with a nominal activity and a serial number. In addition, the eyelet end of each 6500 Series and 6520 Series source is color-coded according to its nominal activity using a long-life epoxy resin.
The lead pig container in which the 6500 Series and 6520 Series tube sources are stored has a label which includes the following:
Descriptsn: Cesium 137 Sources consist of two stainless steel COSiUm-137 capsuies. .n oute, casm. and an i,,,,., co,. con,. n.
Cs-137 - labeled ceramic microspheres.
Brachytherapy Product No.
Sources Total Activity This Container mci Cs-137 Number of Sources: 1 Made in U.S.A. for Radiation Therapy Products Assay Date:
Medical Products Division /3M St. Paul, MN 55501 Store Source in shielded container provided, or in an equivalent container with a shielding value equal to one inch of lead.
WARNING: Licensed by the U.S. CAUTION: Federallaw restricts radiation trefoil / Nuclear Regulatory Commission this device to sale by or on the Caution Radioactive for distribution to persons order of a physician. Maintain Material licensed pursuant to i 35.14 proper radiation safety precautions and n 35.100 Group VI of to at all times.
l CFR Part 35 or under equivalent licenses of Agreement States.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-906-S DATE: January 26, 1996 PAGE 5 OF 9 SEALED SOURCE TYPE: Tube Source CONDITIONS OF NORMAL USE:
The 6500 Series and 6520 Series sources are intended for use in intercavitary treatment of cancer. These sources are intended to be used in conjunction with other treatment modalities. The sources are preloaded or afterloaded into an applicator for use in treating a patient.
PROTOTYPE TESTING:
Prototypes of the 6500 Series sources containing approximately 12.50 mci (462.5 MBq) of Cs-137 were subjected to the following prototype tests:
- 1. Temperature Test: Two 6500 Series sources were placed in a 1558.4*F i 36*F (848*C 20*C) oven and left there for 77 minutes. Upon removal from the oven, the sources were dropped into water at a temperature of 57.2*F (14.0*C).
Visual inspection of the sources after heating revealed no obvious structural defects. The wipe, leak, and soak tests were all negative for these two sources.
- 2. Imoact Test: Two 6500 Series sources were dropped from a height of 29.53 feet (9.000 m) onto a flat, 0.500 in.
(1.270 cm) thick steel plate. Visual inspection of the sources after the impact test revealed no obvious defects.
The wipe, leak, and soak tests were all negative for these two sources.
- 3. Percussion Test: A 0.984 in. (2.500 cm) diameter steel bar weighing 3.198 lbs (1.451 kg) was dropped through a 1.378 in. (3.500 cm) inner diameter guiding sleeve onto each of the sources used in the Impact Test. The sources were lying horizontally on a 1.000 in. (2.540 cm) thick lead brick.
One source was positioned so the center of the bar hit the l source's center, and the other source was positioned so the
! edge of the bar hit the cent.:r of the source. Upon visual inspection after the percue-ton test, the former source l
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l
NO.: NR-460-S-906-S DATE: January 26, 1996 PAGE 6 OF 9 SEALED SOURCE TYPE: Tube Source l
1 PROTOTYPE TESTING (Continued)
J l
showed a bend of about 20' from the long axis of the source. No )
defects were observed in the latter source. The wipe, leak, and soak tests were all negative for these two sources.
After each test, the tested sources were subjected to wipe / smear, leak, and soak tests. The allowable limit of removable '
contamination for the wipe and soak tests was 0.0005 Ci (18.50 Bq). The soak test involved completely immersing the sources in distilled water heated to a temperature of at least 104*F (40'C) for a minimum of 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br />. The leak test involved immersing the sources in glycerin heated to about 302*F (150*C) l for at least one minute. All sources indicated no loss in !
- containment integrity.
EXTERNAL RADIATION LEVELS:
The manufacturer provided the following calculated dose rates:
DOSE RATE AT I l Est. Output 5 cm (1.97 in.) 30 cm (11.8 in.) 100 cm (39.4 in.)
f Activity aci mR/hr (msv/hr) mR/hr (mSv/hr) mR/hr (mSv/hr)
(MBq) l 11.6 (429.2) 1,524 (15.24) 42.30 (0.423) 3.81 (0.038) l 25.1 (928.7) 3,288 (32.88) 92.30 (0.923) 8.22 (0.082)
- l. 37.2 (1376) 4,880 (48.80) 135.5 (1.355) 12.20 (0.122) l 57.1 (2113) 7,492 (74.92) 208.0 (2.080) 18.70 (0.187) 72.6 (2686) 9,520 (95.20) 264.0 (2.640) 23.80 (0.238) i
! 93.0 (3441) 12,200 (122.0) 338.9 (3.389) 30.50 (0.305)
OUALITY ASSURANCE AND CONTROL:
The following quality control procedures were followed during I production of these sources: )
- 1. Each inner capsule was leak tested after it was sealed. A negative leak test meant that no air leaks or holes were
)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l'O . : NR-460-S-906-S DATE: January 26, 1996 PAGE 7 OF 9 SEALED SOURCE TYPE: Tube Source OUALITY ASSURANCE AND CONTROL: (Continued) detected while the capsule was immersed in glycerine at a temperature of 248'F - 302'F (120*C - 150'C) for at least 10 seconds.
- 2. Each inner capsule was wipe tested after it was sealed. The allowable limit was 0.0002 C1 (7.400 Bq) of removable Cs-137.
- 3. Each inner capsule was soak tested after it was sealed in 6-7 ml of distilled water at 68*F (20*C) for 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br />. The allowable limit was 0.0002 Ci (7.400 Bq) of detectable Cs-137.
- 4. Each source was wipe tested, after the outer capsule was sealed, as in test 2 above, except that the allowable limit for tnis test was 0.0001 Ci (3.700 Bq).
- 5. Each source was leak tested after the outer capsule was sealed, as in test 1 above.
- 6. Each completed source was leak tested as in test 1 above.
- 7. Each completed source was soak tested. The maximum allowable limit was 0.0005 Ci (18.50 Bq).
- 8. Each completed source was visually inspected to ensure it was nickel plated smoothly and completely with no discoloration, to check for uniform, smooth welds, to check for the proper color code, and to check that the activity (in mg Radium equivalent) and serial number were properly l engraved on the source.
- 9. Each completed source was assayed to ensure its activity was l 0-10 percent above the nominal activity.
- 10. . Prior to shipment, each source was visually inspected for proper labeling, assayed for radioactivity as in (9) above, and wipe tested, with an allowable limit of 0.0001 Ci (3.700 Bq) of removable contamination. Any sources not meeting these final checks were rejected. f i
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REGISTRY OF. RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.: NR-460-S-906-S DATE: January 26,~1996 PAGE 8 OF 9 SEALED SOURCE TYPE: Tube Source
, OUALITY ASSURANCE AND CONTROL: (Continued) i 3m's QA/QC program was found to ~ be acceptable for licensing l' purposes. . A copy of.the program is on file with the Source l: Containment and Devices Branch.
f L ~ LIMITATIONS'AND/OR OTHER CONSIDERATIONS OF USE:
- These sources.may be.used only by persons specifically.
l licensed by the NRC or an Agreement State.
- Handling, storage, use, . transfer, and disposal: to.be determined by the licensing authority. In view that these sealed sources exhibit high surface dose rates when unshielded, these sources should be handled only by
[ experienced personnel using adequate remote handling i
- equipment and procedures.
"
- The sealed sources shall be leak tested at intervals not to exceed 36 months (3 years) using techniques capable of detecting 0.005 microcurie (185.0 Bq) of removable contamination.
- ' This registration sheet and the information contained within the. references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
l'
.The 6500 Series and 6520 Series sources are not current products L manufactured or-distributed by 3M Health Physics Services.
y However, 3M Health' Physics Services will continue to receive ll these sources for disposal.
i l Based on our review of the information and test data cited below,
~
! and-the past history of the source design, we continue to conclude that the 6500 Series and 6520. Series tube sources are acceptable for specific licensing purposes.
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-906-S DATE: January 26, 1996 PAGE 9 OF 9 l
SEALED SOURCE TYPE: Tube Source SAFETY ANALYSIS
SUMMARY
- (continued) i Furthermore,_we continue to conclude that these sources would be expected to maintain their 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 6500 Series and 6520 l Series (formerly 6D6C) sources are hereby incorporated by l
reference and are made a part of this registry document:
- 3M Health Physics Services' letters dated August 6, 1991, November 6, 1990, July 24, 1989, January 17, 1985, and May 1, 1980, with enclosures thereto i
l ISSUING AGENCY: )
U.S. Nuclear Regulatory Commission j Date: January 26, 1996 Reviewer: ~
I
- Di5ugla A. Broaddus
! 7 Date: January 26, 1996 Concurrence: N
' 6< steven IC#8aggett l
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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-906-S DATE: January 26, 1996 ATTACHMENT 1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-906-S DATE: January 26, 1996 ATTACMMENT 2 3M old source design l
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/ February 12, 1996 l
l NOIE T0: MINNES0TA MINING AND MANUFACTURING (3M) INACTIVE FILES l FROM:
1
SUBJECT:
INACTIVATION OF REGISTRATIONS BASED ON AUGUST 6, 1991, LETTER.
A number of the background files for the registration certificates requested ,
(by 3M letter dated August 6, 1991) to be made inactive contain limited !
information on the products. A search of 3M registration, archive, and i license fi'les, and information in NUDOCS was performed to obtain additional information. Also, 3M was contacted to obtain any additional information that may have been in their files. 3M provided limited additional information concerning these products and indicated that the information provided ;
represented all additional information in their files. Additional information obtained from these sources has been added to the applicable registration i files. I At the present time, the information contained in the background registration files represents all available information for these products. In addition, a number of these products were originally reviewed and approved by the Atomic Energy Comission (AEC). The reviews performed for these products to make the certificates inactive were based on the information available, the previous reviews and approvals, and the historical use of the products (i.e., reports of failures or design problems, or the lack thereof). In several instances, insufficient information was available to perform an adequate safety review.
In these instances, the certificates have been reissued based solely on the original AEC review and approval, and no additional safety review was performed.
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t February 29, 1996 _
Robert G. Wissink 3M Health Physics Services 3M Center Bldg. 224-2E-06 St. Paul, MN 55144-1000
Dear Mr. Wissink:
This. letter is in response to your request dated August 6, 1991, and subsequent letters, requesting to transfer to inactive' status all registration l sheets issued to 3M as listed in the first ' column of Enclosure 1. We have transferred the requested certificates to inactive status. The certificate numbers have been changed as listed in Enclosure 1. Copies of the inactive certificates are enclosed for your records.
Please read over the registration certificates and notify us immediately if
- l. there are any errors or inconsistencies.
If you have any questions, please contact me at (301) 415-5847 or Mr. Steven Baggett at (301) 415-7273.
Sincerely,
/S/
Douglas A. Broaddus, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch
- Division of Industrial and Medical Nuclear Safety, NMSS
Enclosures:
As stated l
I f
Distribution:
SSSS R/F NE01 SSD-91-71 Registration certificate files listed in Enclosure 1 DOCUMENT NAME: C:\WPDOCS\SSDS\ INACTIVE \NRC \460lNACT. CMP n w.. w m. - m um.wm c .cm m.m u.a.m.o r . cm .m w u r - n. =,
OFFICE. SCDB lD l l l l l NAME DABroaddus i DATE 02/a/96 I OFFICIAL RECORD COPY l
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ENCLOSURE 1 REGISTRATIONS TRANSFERRED TO INACTIVE STATUS Old Certificate No. New Certificate No. Nodel Number (s)
NR-459-S-101-S NR-8008-S-801-S 4F6Y NR-459-S-102-S NR-8008-S-802-S 3 FIG NR-460-S-101-S NR-0460-S-875-3 4F6D NR-460-S-102-S COMBINED WITH 4F6H, 4F6B NR-0460-S-874-S NR-460-S-103-S NR-0460-S-876-S 4F6G NR-460-S-104-S COMBINED WITH 606A NR-0460-S-865-S NR-460-3-105-S NR-0460-S-877-S 6B6F NR-460-S-106-S NR-0460-S-878-S 4F6P NR-460-S-107-S NR-0460-S-879-S 1C2A, IC2B NR-460-S-108-S NR-0460-S-880-S 4F3B NR-460-S-109-S NR-0460-S-881-S 4F3C NR-460-S-110-S NR-0460-S-882-S 3MIC NR-460-S-111-S NP.-0460-S-883-S 3MlB NR-460-S-112-S NR-0460-S-884-S 3E4G NR-460-S-113-S NR-0460-S-885-S 4D3A NR-460-S-114-S NR-0460-S-886-S 4D3B NR-460-S-115-S NR-0460-S-887-S 4D6D NR-460-S-116-S NR-0460-S-888-S 4D6F NR-460-S-117-S NR-0460-S-889-S 5FID NR-460-S-Il8-S COMBINED INf0 SFIE
~ ~ ~
NR-460-S-119-S 5FIF NR-460-S-120-S NR-0460-S-891-S 5 FIG NR-460-S-121-S NR-0460-S-892-S 3L2B NR-460-S-122-S NR-0460-S-893-S 3L2A NR-460-S-123-S NR-0460-S-894-S 3MlF NR-460-S-124-S NR-0460-S-895-S 3L2C L-___------
I l
I ENCLOSURE 1 REGISTRATIONS TRANSFERRED TO INACTIVE STATUS Old Certificate No. New Certificate No. Nodel Number (s)
NR-460-S-125-S NR-0460-S-896-S 1E2J NR-460-S-126-S NR-0460-S-897-S 3 FIG NR-460-S-127-S NONE - NO INFORMATION 4FIE AVAILABLE NR-460-S-128-S NR-0460-S-899-S 5FlH NR-460-S-129-S NR-0460-S-900-S 3E40 NR-460-S-130-S COMBINED INTO SFIN NR-460-S-131-S NR-0460-S-901-S 5 FIN (MODIFIED)
NR-460-S-132-S NR-0460-S-902-S 7B8L NR-460-S-133-S COMBINED INTO 6H6A NR-460-S-134-S
~
6H6B NR-460-S-135-S NR-0460-S-904-S 4D6M NR-460-S-136-S NR-0460-S-905-S 3L2E NR-460-S-137-S NR-0460-S-906-S 6500, 6520 (FORM. 6D6C)
NR-460-S-138-S NR-0460-S-907-S 3L2D I NR-460-S-139-S NR-0460-S-908-S 3Q10 l NR-460-S-140-S NR-0460-S-909-S 3E4L, 3E4S ;
NR-460-S-141-S NR-0460-S-910-S 3 FIR NR-460-S-142-S NR-0460-S-911-S 902, 902F, 903 NR-460-S-143-S COMBINED WITH 4P6E I NR-0460-S-871-S NR-460-S-144-S COMBINED WITH 4P6M NR-0460-S-872-S NR-460-S-145-S NR-0460-S-912-S 3Mll NR-460-S-146-S NR-0460-S-913-S 3G9A NR-460-S-147-S NR-0460-S-914-S 3B4G NR-460-S-148-S COMBINED WITH 4F3F NR-0460-S-871-S NR-460-S-149-S NR-0460-S-915-S 4F3G
[. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ -
ENCLOSURE 1 REGISTRATIONS TRANSFERRED TO INACTIVE STATUS
! Old Certificate No. New Certificate No. Model Number (s)
NR-460-S-150-S NR-0460-S-916-S 6DIA NR-460-S-151-S COMBINED WITH 6530, 6540 (FORM. 6B6G)
NR-0460-S-869-S NR-460-S-152-S NR-0460-S-917-S 6H6D NR-460-S-153-S NOT REQUIRED ALBUMIN MICR0 SPHERES l NR-460-S-154-S NR-0460-S-919-S 6H6E, 8C9T NR-460-S-155-S COMBINED INTO 4D6L
' '~
NR-460-S-156-S 4D6P NR-460-S-158-S NR-0460-S-921-5 3FlI, 3FlJ, 3Fll NR-460-S-159-S NR-0460-S-922-S 3FlV NR-460-S-160-S COMBINED WITH 4P6T NR-0460-S-873-S l NR-460-S-161-S COMBINED INTO 4F3D NR-0460-S-920-S NR-460-S-162-S NR-0460-S-923-S 4F3H NR-460-S-163-S COMBINED INTO 4F6S NR-0460-S-920-S NR-460-S-164-S COMBINED WITH 3E40 NR-0460-S-900-S i
NR-460-S-165-S NR-0460-S-924-S 6701 NR-460-S-166-S NR-0460-S-925-S 6702 NR-460-S-167-S NR-0460-S-926-S 6711 NR-460-S-168-G NR-0460-S-927-G 702, 703, 704 NR-460-S-169-S NR-0460-S-928-S 6510, 6550, 6570 (FORMERLY 6B6G)
NR-460-S-170-S NR-0460-S-929-S 4P6V l
! NR-460-S-171-S NR-0460-S-930-S 4F6ST I
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