ML20247R731
| ML20247R731 | |
| Person / Time | |
|---|---|
| Issue date: | 01/26/1996 |
| From: | Steven Baggett, Doug Broaddus NRC |
| To: | |
| Shared Package | |
| ML20247R739 | List: |
| References | |
| SSD, NUDOCS 9805290206 | |
| Download: ML20247R731 (7) | |
Text
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO,: NR-460-S-877-S DATE: January 26, 1996 PAGE 1 OF 6 SEALED' SOURCE TYPE:
Medical Needle Source J
MODEL:
6B6F-l MANUFACTURER / DISTRIBUTOR:
3M Health Physics Services 1
3M Center, Building 224-2E-06 St. Paul; MN 55144-1000 ISOTOPE:'
MAXIMUM ACTIVITY:
Cesium-137 500.0. millicuries ~(18.50 GBq) l LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(V) General Medical Use i
i l
I' t
' CUSTOM SOURCE:
YES X
'NO I
9iB05290206 960126
~
- -____-___=__________- _ _ _ _ _ _ _ _ _ _ _ _
!s REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION.OF SEALED SOURCE NO.: NR-460-S-877-S_
DATE: January 26, 1996 PAGE 2 OF 6-SEALED-SOURCE TYPE:
Medical Needle Source DESCRIPTION:
The 6B6F sealed source is a stainless steel needle intended for interstitial implantation in cancer. treatment.
Cesium-137 (Cs-137) is absorbed;into small ceramic; particles.
The isotope is then permanently fixed to the ceramic particles using a heat treatment to create 3M Brand Radiating Microspheres.
The microspheres are then loaded into a 0.050 in. (0.127 cm) outer diameter tube with nominally 0.009 in. (0.023 cm) thick walls.
The length of this tube (L27) and the active length (L ) of the A
source vary according to Table I, below.
A 0.040 in. (0.102 cm)
. thick plug is inserted into each end of this tube, and silver-soldered in place.
The entire assembly is inserted into a 0.072 in. (0.183 cm) outer diameter tube with 0.009 in. (0.023 cm) thick walls that extend 0.040-in. (0.102 cm) past both ends of the inner tube.
A needle point is inserted into one end of the outer tube and silver-soldered in place.
A long plug with an eyelet 0.125.in.
(0.318 cm) from its rounded end is inserted into the.other end of 1
the outer tube and silver-soldered in place.
The total length (Lr)' of the completed source varies according to Table I.
l TABLE I.
Dimensions of the 6B6F Source Size Total Length Active Length Inner Tube Code (L l (L )
Len.
(L l i
3 it TNA 1.3779 in.
0.7874 in.
0.8924 in, j
3.500 cm 2.000 cm 2.267 cm TNB 1.7716 in.
1.1811 in.
1.2861 in.
4.500 cm 3.000 cm 3.267 cm TNC 2.1653 in.
1.5748 in.
1.6798 in.
5.500 cm 4.000 cm 4.267 cm TND 2.5590 in.
1.9685 in.
2.0731 in.
6.500 cm 5.000 cm 5.266 cm TNE 2.9527 in.
2.3622 in.
2.4672 in.
7.500 cm 6.000 cm 6.267 cm a
~
- _ _ _ _ _ _ - - - - - _ _ _ _. - _ _ _. _ _ _ _ _. _ _ _ _. _ _ _ _. - - - _ - - _ _. _. _ _ _ _ _. _ _ _ - _ _. - - _. _ _ _ _ _. _ _ _ _ _. _ _ _ -. - _ _ _. - _ _. - _ - _ _ - _ _. - _ _ _. _.. _ _ _ _ _ _ _... _ _ _ _ _ _ _ _ _ _ - _ - _ _ _ _ _ - _ ~ _ -. -. - - -. - -.. ~ _ _ _ _ _ _ _.. -. _ _
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-877-S DATE: January 26, 1996 PAGE 3 OF 6 SEALED SOURCE TYPE:
Medical Needle Source DIAGRAM:
See Attachment 1 LABELING:
The quantity of Cs-137 contained in the source and the date of manufacture are stamped on the eyelet end of the source.
CONDITIONS OF NORMAL USE:
This source is intended for use in interstitial brachytherapy, which involves implanting the source in the patient's body near a carcinoma or tumor so that the radiation will destroy the cancer.
Therefore, the source is designed to withstand the internal environmental conditions inside the human body for extended periods.
When the source is not in use, it is stored in a
- climate-controlled hospital room.
PROTOTYPE TESTING:
~ Prototype Model 6B6F sources containing between 1.000 mci (37.00 MBq) and 5.000 mci (185.0 MBq) of Cs-137 were subjected to the:following tests:
1.-The sources were dropped from a height of 48.00 in.
(121.9 cm) onto a cement surface six times.
- 2. The sources were heated at 932*F (500*C) for 30 minutes.
3.
The sources were soaked in a 5 percent saline solution at 140'F (60*C) for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
- 4. The sources were soaked in blood at 140'F (60*C) for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
l l
1 REGISTRY OF RADIOACTIVE SEALED-SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-877-S DATE: January 26, 1996 PAGE 4 OF 6 SEALED SOURCE TYPE:
Medical Needle Source PROTOTYPE TESTING: (Continued)
After each test'the sources were. smear and leak tested.
All H
smears revealed less than 0.001 Ci (37.00 Bq) and all leak tests were negative.
EXTERNAL RADIATION IEVELS:
External radiation dose rates were calculated for a 500.0 mci (18.50 GBq) Cs-137 source as follows:
Distance Maximum Radiation Level (from surface)
(cm)
(in)
(R/hr)
(Sv/hr) 5 1.97 66 0.66 30 11.81 1.83 0.018 100 39.37 0.165 0.002 OUALITY ASSURANCE AND CONTROL:
The following quality control procedures were followed during production of this source:
1.
Each source was smear tested upon completion of fabrication, after.a 7-day storage period, and immediately prior to shipment.
2.
Each source was bubble-leak-tested in water at 200*F (93.33*C) for a minimum of 10 seconds.
If any bubbles were observed coming from the source, the source failed the test.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-877-S DATE: January 26, 1996 PAGE 5 OF 6 1
J SEALED SCURCE TYPE:
Medical Needle Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
This source may be used only by persons specifically licensed by the NRC or an Agreement State.
Handling,. storage, use, transfer, and disposal: to be determined by the licensing authority.
This source shall be leak tested at' intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185.0 Bq) of 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
i The Model 6B6F sealed source is not a current product I
manufactured or distribut'ed by 3M Health Physics Services.
However, 3M Health Physics Services will continue to receive 6B6F sources for disposal.
Based on our review of the Model 6B6F sealed source, and the information and test data cited below, we continue to conclude that this sealed source is acceptable for specific licensing purposes.
Furthermore, we continue to conclude that the Model 6B6F-sealed source 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.
l l
I r
1
.I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION CF SEALED SOURCE NO.: NR-460-S-877-S DATE: January 26, 1996 PAGE 6 OF 6 I
SEALED SOURCE TYPE:
Medical Needle Source
REFERENCES:
1
.The following supporting documents for the Model 6B6F sealed l
source are hereby incorporated by reference and are made a part l
of this registry document:
3M Health Physics Services' letters dated August 6,
- 1991,
)
and January 24, 1964,.with enclosures thereto ISSUING AGENCY 1 U.S. Nuclear Regulatory Commission j
l Date:
January 26, 1996 Reviewer:
Ib C6ouglas A. Bro'addus Date:
January 26, 1996 Concurrence:
' keven L.
6aggett i
1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-460-S-877-S DATE: January 26, 1996 ATTACHMENT J.
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NUCLEAR REGULATORY COMMISSION l
t WASHINGTON, D.C. 20566-0001 l
l
- o 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 l
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 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 j
certificates inactive were based on the information available, the previous l
reviews and approvals, and the historical use of the products (i.e., reports i
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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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 l
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,
/,3/
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:
SSSS R/F NE01 SSD-91-71 Registration certificate files listed in Enclosure 1 DOCUMENT NAME: C:\\WPDOCS\\SSDS\\ INACTIVE \\NRC\\460lNACT. CMP Ts seesive e sepy of tido dooumont,indeste in the bec
- C' = Copy without ettechment/encloswo
- E* = copy with attachment /encioewe
- N' = No copy 0FFICE SCDB lC l
l l
l l
NAME DABroaddus l
DATE 02/27/96 OFFICIAL RECORD COPY
~
b 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-S 4F60 NR-460-S-102-S COMBINED WITH 4F6H, 4F68 NR-0460-S-874-S NR-460-S-103-S NR-0460-S-876-S 4F6G NR-460-S-104-S COMBINED WITH 6D6A NR-0460-S-865-S NR-460-S-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 IC2A, IC2B NR-460-S-108-S NR-0460-S-880-S 4F3B NR-460-S-109-S NP-0460-S-881-S 4F3C NR-460-S-110-S NR 0460-S-882-S 3MIC NR-460-S-Ill-S NR-0460-S-883-S 3MIB NR-460-S-ll2-S NR-0460-S-884-S 3E4G NR-460-S-ll3-S NR-0460-S-885-S 4D3A I
i 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 406F NR-460-S-Il7-S NR-0460-S-889-S 5FID NR-460-S-118-S COMBINED INTO 5FIE i
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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-;22-S NR-0460-S-893-S 3L2A NR-460-5-123-S NR-0460-S-894-S
?M1F NR-460-S-124-S NR-0460-S-895-S 3L2C
V ENCLOSURE I REGISTRATIONS TRANSFERRED TO INACTIVE STATUS Old Certificate No.
New Certificate No.
Model 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 l
1 AVAILABLE NR-460-S-128-S NR-0460-S-899-S 5FIH NR-460-S-129-S NR-0460-S-900-S 3E40 NR-460-S-130-S COMBINE 0 INTO 5 FIN NR-460-S-131-S NR-0460-S-901-S 5 FIN (MODIFIED)
NR-460-S-132-5 NR-0460-S-902-S 788L NR-460-S-133-S COMBINED INTO 6H6A NR-460-S-134-S
~
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)
HR-460-S-138-S NR-0460-S-907-S 3L2D NR-460-S-139-S NR-0460-S-908-S 3Q10 NR-460-S-140-S NR-0460-S-909-S 3E4L, 3E45 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 l
NR-460-S-144-S COMBINED WITH 4P6M NR-0460-S-872-S i
NR-460-S-145-S NR-0460-S-912-S 3Mll NR-460-S-146-S NR-0460-S-913-5 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 l
.L ENCLOSURE 1 REGISTRATIONS TRANSFERRED TO INACTIVE STATUS Old certificate No.
New Certificate No.
Nodel 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-917-5 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
~
~
4D6P NR-460-S-158-S NR-0460-S-921-S 3Fil, 3F1J, 3FIL NR-460-S-159-S NR-0460-S-922-S 3 fly NR-460-S-160-S COMBINED WITH 4P6T NR-0460-S-873-S 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 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 NR-460-S-171-S NR-0460-S-930- S 4F6ST l
_ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ -