ML20151D790
| ML20151D790 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 09/10/1987 |
| From: | Jennifer Davis NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20151D793 | List: |
| References | |
| NUDOCS 8804140448 | |
| Download: ML20151D790 (3) | |
Text
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U.S. NUCLE AR T.E!ULATOY COMMIS$10N f
Ll MATERIALS LICENSE Amendment hu. 21 Pursur it to the Atomic Energy Act of 1954, as amended. the Energy Reorganization Act of 1974 (Public Law 93 -438) and litle 10. M l
f Code of Federal R(gulations, Chapter I, Parts 30,31,32.33,34,35,40 and 70, and in reliance on statements and representations 1 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receise, acquire, possess, and transfer by proJuct.
l source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below ;to deliser or transfer such material to persons authorized to receive it in accordance with the regulations of the appheable Part(s). This
. i license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is.
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect anJ to any l conditions specified below.
t Ucensee 1
In accordance with letter dated July 15, 1987, g
I-Biocontrol Technology, Inc.
- 3. Ucense number ShM-1319 is amended in g
its entirety to read as follows, p
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- 2-P.O. Box 434 Indiana, Pennsylvania 15701
- 4. Expiration date Septemoer 30, 1990
- 5. Docket or d
Reference No.
.070-01342 p
- 6. By product, source, and 'or 7 Chemical and/or physical
- 5. Maximuni amount that 1:censee M
m special nudear material form
', may possess at any one time
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q jtnder this license A. Plutonium (Principal A. Sealed sources A. Not to exceed 250 lj radionuclide Pu-238)
(Plutoniumbatteries) milligrams of Pu-238 per sealed source; 290 grams g
total l
B. Plutonium 238 B. Sealed neutron source B. 4.~73 curies (Monsanto)
(275 milligrams) 9.
Authorized use h
g A.
(1) For use as a component in assembled Coraton.4c Model C-101 pacemakers and as a Fj component in the assembly (manufacturing) of Coratomic Model C-101-P y
pacemakers; for distribution to medical institutions authorized to receive h
pacemakers pursuant to the terms and conditions of a specific license issued h
by the Nuclear Regulatory Commission or an Agreement State.
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a (2)
For recovery as a component of explanted Coratomic Model C-100. C-101 and N}
C-101-P pacemakers transferred from specific licensees.
h4 (3)
For storage or disassembly and re-furbishing of the battery source from f
Coratomic Model C-100, C-101 and C-101-P pacemakers, p
9 B.
For use as a calibration source.
f CONDITIONS V
l 10. Licensed material shall be used only at the licensee's facilities, 300 Indian g
Spring Road, Indiana, Pennsylvania.
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$ 11.
Licensed material shall be used by, or under the supervision uf, individuals who f@
have completed the training program as outlined in the letter dated Augu:t 19, 1985 and have been designated by Frederick J. Shipko, Radiation Safety Officer,
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MATERIALS LICENSE SNM-1319 0-01342 l
SUPPLEMENTARY SHEET l
I Amendment No. 21 p
(Continued)
CONDITIONS I
l
- 12. As six tronth intervals the licensee shall collect and tally data from all medical l
institutions with respect to:
(a) accountability, removal and recovery, f
I (b) duration of satisfactory performance or the time of service before malfunction, b
I and (c) nature of malfunction (if appropriate) of all implanted Coratomic Model b
I C-100, C-101, and C-101P nuclear-powered pacemakers. Within ninety (90) days of the b
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six month period ending February 28 or August 31, a copy of the report shall be sent to the U.S. Nuclear Regulatory Commission, Region I, Nuclear Materials Safety
(
i Section, 631 Park Avenue, King of Prussia Pennsylvania 19406.
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- 13. The licensee shall maintain records of the' medical institutions approved by the h
1 FDA for participation in 10E G 610104/A2 and the date of FDA's approval of each I
institution.
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- 14. This license does not authorize the implantation of pacemakers into humans or l
1 animals.
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h A(1) Any sealed sources or detector cells specified in Items 7.A amd 7.B shall be 1
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15.
tested for leakage and/or contamination at intervals not'to exceed 6 months.
Any source or detector cell receiveo from another person which is not p
1 accompanied by a certificate indicating that a test was performed within g
1 6 months before the transfer shall not be put into use until tested.
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(2) Notwithstanding the periodic leak test' required by this condition, any I
licensed sealed source or detector cell is exempt from such leak tests
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when the source or detector cell contains 100 microcuries or less of beta f
and/or gamma emitting raterial or 10 microcuries or less of alpha emitting y
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- material, p
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1 B.
Any sealed source or detector cell in storage and not being used need not be tested. When the source or detector cell is removed from storage 4
f for use or transfer to another person, it shall be tested before use or h
1 transfer.
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1 C.
The test shall be capable of detecting the presence of 0.005 microcurie
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I of radioactive material on the test sample.
If the test reveals the I
presence of 0.005 microcurie or more of removable contamination, the E
f source or detector cell shall be removed from service and decontaminated, p
repaired, or disposed of in accordance with Comission regulations.
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report shall be filed within 5 days of the date the leak test result is y>
J known with the U.S. Nuclear Regulatory Commission Region 1. ATTh:
- Chief, l
Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of I
Prussia, Pennsylvania 19406. The report shall specify the source involved.
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I the test results, and corrective action taken. Records of leak test e
results shall be kept in units of microcuries and shall be maintained for h
1, inspection by the Comission.
Records may be disposed of following y
q Commission inspection.
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RC Form 374A U. S.
E A'I REGULATORY COMMIS$10N 3
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MATERIALS LICENSE S
1319 SUPPLEMENTARY SHEET 070-01342 l
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Amendment No. 21 p
I (15. continued)
CONDITIONS 1
l D.
Tests for leakage and/or contamination shall be performed by the licensee i
or by other persons specifically licensed by the Comission or an Agree-I ment State to perform such services.
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16.
The licensec may transport licensed material in accordance with the provisions I
of 10 CFR Part 71, "Packaging and Transportation of Radioactive Material".
- 17. The licensee shall conduct a physical inventory every 6 months to account for l
1 all sources and/or devices rcceived and possessed under the license.
Records l
of inventories shall be maintained for 2 years from the date of each inventory.
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l10. Except as specifically provided otherwise in this license, the licensee shall
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conduct its program in accordance with the statements, representations, and g
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procedures contained in the docurrents including any enclosures, listed below.
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The Nuclear Regulatory Comission's regulations shall govern unless t.he state-I ments, representations and procedures in the licensee's application and corre-t I
spondence are more restrictive than the regulations.
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l A.
Application dated May 2,1965 t
j B.
Letter dated August 19, 1985 p
I C.
Letter dated July 10, 1986 k
l D.
Letter dated July 15, 1987 1
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f For the U.S. Nuclear Regulatory Commission i!
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'10 SEP 1987
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Tack Devis
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Date By I
huclear baterials Safety anc I
Safeguards Branch, Region 1 l
King of Prussia, Pennsylvania 19406 ki 6 m v----------m.
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