ML20247R233
| ML20247R233 | |
| Person / Time | |
|---|---|
| Issue date: | 01/26/1996 |
| From: | Steven Baggett, Doug Broaddus NRC |
| To: | |
| Shared Package | |
| ML20247R240 | List: |
| References | |
| SSD, NUDOCS 9805290096 | |
| Download: ML20247R233 (8) | |
Text
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~ REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE-l l
l NO.: NR-460-D-882-S DATE: January 26, 1996 PAGE 1 OF 7 DEVICE TYPE:
Fluid Beta Irradiator MODEL:
3M1C MANUFACTURER / DISTRIBUTOR:
3M Health Physics Services 3M Center, Building 224-2E-06 St. Paul, MN 55144-1000 SEALED SOURCE MODEL DESIGNATION:
3M Radiating Microspheres ISOTOPE:
MAXIMUM ACTIVITY:
Strontium-90/ Yttrium-90 2.000 curies (74.00 GBq)
LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(T) Other CUSTOM DEVICE:
YES X
NO 9805290096 960126 PDR RC
' " " -SSD PDR
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i
NO.; NR-460-D-882-S DATE: January 26, 1996 EAGE 2 OF 7 l
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DEVICE TYPE:
Fluid Beta Irradiator l
DESCRIPTION:
The Model 3M1C irradiator consists of two tube assemblies, which contain the radioactive source material, a split body, and two end caps.
The tube assemblies fit into 0.060 in. (0.152 cm) square detents along the sides of the 0.212 in. (0.539 cm) diameter central circular shaft.
The two halves of the split body are fastened together using four #10, 1.000 in. (2.540 cm) long cap screws, for which the holes were pre-drilled.
The end caps have a 0.210 in. (0.533 cm) diameter, 0.500 in. (1.270 cm) long shaft that fits into the central 0.212 in. (0.539 cm) i circular shaft which holds the tube assembly in place.
The end caps are fastened to the split body using four #10 flat-head machine screws for each end cap.
All components of the device are fabricated from type-304 stainless steel.
The tube assemblies contain 3M Brand Radiating Microspheres. The microspheres are made by absorbing Sr-90/Y-90 into ceramic particles, then permanently affixing the isotope to the particles with a heat treatment.
The microspheres are inserted into a L
stainless steel tube with an outer diameter of 0.040 in.
(0.102 cm) and a wall thickness of 0.002 in. (0.005 cm).
This tube is silver brazed shut to seal in the radioactive microspheres and is then inserted into a second stainless steel j
tube with an outer diameter of 0.054 in. (0.137 cm) and a wall I
thickness of 0.002 in. (0.005 cm).
The outer tube is also silver l
brazed to fasten the inner tube inside it.
Each completed tube
)
assembly is 5.000 in. (12.70 cm) long with an active length of 4.000 in. (10.16 cm).
The split body consists of a stainless steel cylinder 5.000 in.
(12.70 cm) long with a diameter of 2.000 in. (5.080 cm), with a stepped split along its axis.
The cylinder is drilled to accept four countersunk #10 cap screws across its body.
These screws will hold the two halves of the body together.
The cylinder is also drilled to accept four #10 flat-head machine screws on each end.
A detent is machined out of each half of the split body.
i The machining leaves a channel centered on the cylinder's axis, with a semicircular cross section 0.212 in. (0.539 cm) in l
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i
SAFETY EVALUATION OF DEVICE l
NO,: NR-460-D-882-S DATE: January 26, 1996 PAGE 3 OF 7 DEVICE TYPE:
Fluid Beta Irradiator l
l 1
DESCRIPTION (Continued):
I diameter, and a 0.060 in. (0.152 cm) square section located 90*
to the cylinder split.
Each end cap is a stainless steel disc 2.000 in. (5.080 cm) in diameter and 0.500 in. (1.270 cm) thick with a 0.210 in.
(0.533 cm) outside diameter by 0.500 in. (1.270 cm) long cylinder extending from one side.
Each end cap is drilled to accept four countersunk #10 machine screws.
The holes are drilled equidistant from each other around a 1.500 in. (3.810 cm) diameter circle centered concentrically with the end cap's center (and the cylinder's axis).
The holes line up with those drilled in the ends of the split body.
Also, each end cap has a 0.150
)
in. (0.381 cm) diameter cylindrical shaft drilled through its center, to line up with the shaft through the split body.
To use an assembled irradiator, a 0.150 in. (0.381 cm) outer diameter plastic tube is inserted through the center channel in i
the irradiator formed by the channels through the centers of the j
end caps and the split body.
The materials being irradiated are piped through this tube.
Therefore, they are irradiated without ever touching the irradiator.
DIAGRAM:
See Attachment 1 l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-460-D-882-S DATE: January 26, 1996 PAGE 4 OF 7 DEVICE TYPE:
Fluid Beta Irradiator LABELING:
The device bears a color label, magenta on a yellow background, with the following:
CAUTION RADIOACTIVE MATERIAL (radiation trefoil)
Model Ser. No.
Isotope mc Date Minn. Mining & Mfg. Co.
St. Paul, Minn.
j CONDITIONS OF NORMAL USE:
The 3M1C irradiator is intended for use in a hospital or laboratory environment, where blood or other fluids are pumped j
through a tube inserted through the irradiator.
As it passes i
through the irradiator, the fluid is irradiated.
i PROTOTYPE TESTING:
A series of bare tubes, loaded with 50.00 millicuries (1.850 GBg) of Sr-90 were subjected to the following prototype tests:
- 1. Heat to 752'F (400*C) and hold for 30 minutes.
2.
Heat to 392'F (200 C) and hold for 30 minutes followed by a quench in tap water (68'F/20'C).
- 3. Bend the tube into an arc of a 3.000 in. (7.620 cm) diameter circle.
Smear tests of the tubes after each prototype test yielded less than 0.005 microcuric (185.0 Bq) of removable Sr-90.
In addition to the prototype tests conducted on the tube assemblies, an assembled irradiator was vibrated at 280 cycles per minute (4.67 Hz) amplitude for 144 hours0.00167 days <br />0.04 hours <br />2.380952e-4 weeks <br />5.4792e-5 months <br />.
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REGISTRY OF h\\DIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HO 1 NR-460-D-882-S DATE: January 26, 1996 PAGE 5 OF 7 t
DEVICE TYPE:
Fluid Beta Irradiator EXTERNAL RADIATION LEVELS:
External radiation dose rates at the surface of the fluid beta irradiator due to the bremsstrahlung radiation created by the beta particles were calculated and found to be approximately 6.440 mR/hr (0.064 mSv/hr).
OUALITY ASSURANCE AND CONTROL:
The following quality control procedures were employed during the fabrication of the irradiator:
- 2. The inner tube was smear tested before insertion into the outer tube.
The inner tube was always cleaned down to a level of 0.001 microcurie (37.00 Bq) of removable Sr-90.
4.
The completed tube assembly was soak tested in 1% Versene at 122*F (50*C) for 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br />.
- 5. The completed tube assembly was smear tested immediately after fabrication.
6.
The exposed surfaces on the tubes were smear tested after insertion into the housing by running a swab up and down through the opening normally used for the plastic tubing.
7.
Step number 6 was repeated after a seven day hold period.
- 8. Step number 6 was repeated immediately prior to shipment.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
NO.: NR-460-D-882-S DATE: January 26, 1996 PAGE 6 OF 7 DEVICE TYPE:
Fluid Beta Irradiator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
This device may be used only by persons specifically e
licensed by the NRC or an Agreement State.
l Handling, storage, use, transfer, and disposal:
to be determined by the licensing authority.
This device shall be leak tested at intervals not.to exceed 6 months using techniques capable of detecting 0.005 microcurie (185.0 Bq) of removable contamination, q
This registration sheet and the information contained within e
the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
The Model 3M1C irradiator is not a current product manufactured or distributed by 3M Health Physics Services.
However, 3M Health Physics Services will continue to receive 3MIC irradiators for disposal.
Based on our review of the Model 3M1C irradiator, and the information and test data cited below, we continue to conclude that this device is acceptable for specific licensing purposes.
Furthermore, we continue to conclude that the Model 3MIC irradiator 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.
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i-NO.: NR-460-D-882-S DATE: January 26, 1996 PAGE'7 OF 7 DEVICE TYPE:
Fluid Beta Irradiator
REFERENCES:
The following supporting documents for the Model 3M1C irradiator are hereby incorporated by reference and are made a part of this registry document:
3M Health Physics Services' letters dated August 9,
- 1991, and November 9, 1964, with enclosures thereto ISSUING AGENCY:
U.S.
Nuclear Regulatory Commission i
I.
Date:
January 26. 1996 Reviewer:
Ifougl A.
Broaddus Date:
January 26, 1996 Concurrence:
b
,/g$feven If. 'Baggett l
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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-460-D-882-S DATE: January 26, 1996 ATTACHMENT 1 i
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WASHINGTON, D.C. 20565-0001 5
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February 12, 1996 NOTE T0:
MINNES0TA MINING AND MANUFACTURING (3M) INACTIVE FILES hf FROM:
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 license ~ files, 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 prcducts 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 files.
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 Commission (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 l
performed.
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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 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 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, 13 {
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 Distribution:
i 1
SSSS R/F NE01 SSD-91-71 Registration certificate files listed in Enclosure 1 DOCUMENT NAME: C:\\WPDOCS\\SSDS\\ INACTIVE \\NRC\\460lNACT. CMP TJ,eoelve e sepy of thle f-1 Indcate in the ben: 'C" = Copy without ettechment/ enclosure
- E' s Copy with attachment / enclosure
'N' = No copy 0FFICE SCDB lb l
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l NAME DABroaddus DATE 02/27/96 OFFICIAL RECORD COPY sppd -SD
$60.02G0005 y'/'b'
ENCLOSURE 1 REGISTRATIONS TRANSFERRED TO INACTIVE STATUS 1
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-S 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-164-S COMBINED WITH 6D6A NR-0460-S-865-S j
NR-460-S-105-S NR-0460-S-877-S 686F NR-460-S-106-S NR-0460-S-878-S 4F6P NR-460-S-107-S NR-0460-S-879-S IC2A, 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-Il0-S NR-0460-S-882-S 3MIC NR-460-S-111-S NR-0460-S-883-S 3MIB NR-460-S-112-S NR-0460-S-884-S 3E4G l
NR-460-S-113-S NR-0460-S-885-S 4D3A NR-460-S-Il4-S NR-0460-S-886-S 4D3B NR-460-S-Il5-S NR-0460-S-887-S 4D6D NR-460-S-Il6-S NR-0460-S-888-S 4D6F NR-460-S-117-S NR-0460-S-889-S 5FID NR-460-S-Il8-S COMBINED INTO 5FIE
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NR-460-S-Il9-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
ENCLOSURE I REGISTRATIONS TRANSFERRED TO INACTIVE STATUS Old Certificate No.
New Certificate No.
Model Number (s) j, NR-460-S-125-S NR-0460-S-896-S lE2J 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 5 FIN NR-460-S-131-S NR-0460-S-901-S 5 FIN (MODIFIED)
NR-460-S-132-S NR-0460-S-902-S 788L NR-460-S-133-S COMBINED INTO 6H6A NR-460-S-134-S
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6H68 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 NR-460-S-139-S NR-0460-S-908-S 3QlD 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 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 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
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406P NR-460-S-158-S NR-0460-S-921-S 3Fil, 3F1J, 3FIL NR-460-S-159-S NR-0460-S-922-S 3F1V NR-460-S-160-S COMBINED WITH 4P6T l
NR-0460-S-873-S NR-460-S-161-S COMBINED INTO 4F3D l
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 l
NR-0460-S-900-S 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 l
NR-460-S-168-G NR-0460-S-927-G 702, 703, 704 l
NR-460-S-169-S NR-0460-S-928-S 6510, 6550, 6570 (FORMERLY 6B6G)
NR-460-S-170-S NR-0460-S-923-S 4P6V NR-460-S-171-S NR-0460-S-930-S 4F6ST 1
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