ML20207T987

Amend 5 to License SNM-1637 for Bryn Mawr Hosp,Amending License in Entirety

ML20207T987
Person / Time
Site:	07002281
Issue date:	08/04/1986
From:	Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20207T988	List: ML20207T987 ML20207T995 ML20207U002 ML20207U006 ML20207U018 ML20207U022 ML20207U028 ML20207U033 ML20207U042 ML20207U057 ML20207U063 ML20207U071 ML20207U079
References
NUDOCS 8703240475
Download: ML20207T987 (2)

Text

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1 g! NEC Form 374 PACE OF PAGES g (s. s 4 U.S. NUCLEAR REIULATORY COMMISSION E

MATERIALS LICENSE Amendment No. 05 i

g; Pursuant to the Atomic Energy Act of 1954, as arnended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10 g Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g(k deliver or transfer such material to persons authorized to rece j source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to !

f license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amen 4 subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any j g conditions specified below.

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Licensee

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f In accordance with application dated l

March 13, 1986, gl I-The Bryn Mawr Hospital

3. Ucense number SNM-1637 is amended in q

Nj its entirety to read as follows:

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N 2-Bryn Mawr Avenue cbh ti D

4. Exp ration

. August 31, 1991 l

Bryn Mawr, Pennsylvania 19010

5. Docket er 4'(

Reference No.

070-02281

6. Byproduct, source, and/or

7. Chemical and/or physical v 8. Maximum amount that licensee special nuclear material form

- Q.may possess at any one time l

under this license

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A. 0.5 grams (individual A. Plutonium (principal A. Sealed Source

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radionuclide Pu-238) sources not to exceed Hl i\\

250 milligrams each) t)) ~

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Authorized use J

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,% p Implantation in humans as a component )ofls Corotomic Model C-101"Tuclear pow y

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cardiac pacemakers for clinical evaluation.,

l%l CONDITIONS j.

f 10. Licensed material shall be used only at the Bryn Mawr Hospital, Bryn Mawr Avenue, V

Bryn Mawr, Pennsylvania.

g n!11. The specified possession limit includes-all -licensed material possessed by the

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dl licensee under this license whether in storage, implanted in patients, or I*

otherwise in use.

12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN:

Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of Prussia, Pennsylvania 19406, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear pacemaker patient, and any adverse reaction and/or malfunction a:

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involving a pacemaker system, including the leads. A written report giving details of the adverse reaction and/or malfunction shall be submitted within

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30 days.

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13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, g

euN ATTN:

Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, p,

D King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a pj,J nuclear pacemaker patient, l/l f

ont M 14. The lict.nsee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient. Procedures for recovery k h 4

and authorized disposal of the nuclear pacemaker by return to the manufacturer f, '

R shall be followed upon the death of the patient.

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i NTC Form 374A U.S. NL, R cEEULATCY COMMISSION

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PAGES I

1. • D I

License number N

SNM-1637 l

MATERIALS LICENSE Dockem Rekonce numW g

l SUPPLEMENTARY SHEET 070-02281 y

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l Amendment No. 05 l

1 l

(Continued)

CONDITIONS R

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15. Sealed sources or detector cells containing licensed material shall not be I

opened or sources removed from detector cells by the licensee.

I I

16. The licensee may transport licensed material in accordance with the provisions l

of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material".

17. Except as specifically provided otherwise in this license, the licensee shall I

conduct its program in accordance with the, statements, representations, and l

l procedures contained in the documents iric)udi[ig any enclosures, listed below.

l l

The Nuclear Regulatory Commission's'riegulations thall govern unless the state-u l

ments, representations and procedures in the licensee's application and corre-l spondence are more restrictive than the regulations.

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n A.

Application transmitted with letter dated March 19, 1976 p

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Letter cated January 13, 1977 7 >

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Letter dated April 27, 1981 F

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Letter dated May 19, 1981

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Letter dated March 13, 1986 l:

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Letter dated July 10, 1986 r

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For the U.S. Nuclear Regulatory Commission l

l Original Signed ByI g

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Date AUG 0 41986 By I

Nuclear haterials Safety and F

I Safecuards Branch, Region I I

I King of Prussia, Pennsylvania 19406 l

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