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CORRECTE0 COPY klS. NUCLEAR REGULATORY COMMISSION PAGC [_ OF 3 PAGES | |||
;q ts-s o MATERIALS LICENSE Amendment No. 21 Pursu;nt to the AtonQ Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10. | |||
Code of Federal Regulations, Chapter I, Paris 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations f heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p N l source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to h' 1[% deliver or transfer such material to persons authorized to receive it in accord.uee withj i the h license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and .sj i subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect aad to any l l | |||
(! conditions specified below. i Lt r Licensee l In accordance with letter dated | |||
]i j | |||
: 3. fulge 15 a nuab"1987, I | |||
'' Biocontrol Technology, Inc. SNM-1319 is amended in i its entirety to read as follows: | |||
g , | |||
2' s P.O. Box 434 - , 4. Expiration date Indiana, Pennsylvania 15701 September 30, 1990 q | |||
: 5. Docket or gj g Reference No. 070-01342 ad | |||
!4l 6. Byproduct, source.and/or 7. Chemical and/or physical 8. Maximum amount that licensee 3l> | |||
h special nuclear material form may possess at sny one time / | |||
under this license l A. Plutonium (Principal A. Sealed sources A. Not to exceed 250 l l% cadionuclide Pu-238) ~(Pl.utonium batteries) milligrams of Pu-238 per sealed source; 290 grams l4 j{ | |||
;i x total | |||
,i B. Plutunium 238 B. Sealed neutron source B. 4.73 curies i i -(Monsanto) (275 milligrams) ; | |||
i vi , | |||
! l ! | |||
: 9. Authorized use lpl | |||
,d | |||
%y$A. (1) For use as a component in assembled Coratomic Model C-101 pacemakers and as a l l | |||
{9 component in the assembly (manufacturing) of Coratomic Model C-101-P i pacemakers; for distribution to medical institutions authorizea to receive y | |||
h[4 Id | |||
! pacemakers pursuant to the terms and conditions of a specific license issued by the Nuclear Regulatory Commission or an Agreement State. pl 1 | |||
54l ' | |||
,i (2) For recovery as a component of explanted Coratomic Model C-100, C-101 and j C-101-P pacemakers transferred from specific licensees. l i | |||
i | |||
,l (3) For storage or disassembly and re-furbishing of the battery source from i)p Coratomic Model C-100, C-101 and C-101-P pacemakers. p l N P | |||
>{j B. For use as a calibration source. | |||
I Y,* | |||
l CONDITIONS l | |||
Licensed material shall be used only at the licensee's facilities, 300 Indian . | |||
l10. Spring Road, Indiana, Pennsylvania. | |||
lt l' | |||
A. Licensed material shall be used by, or under the supervision of, individuals l$11. l who have completed the training program as outlined in the letter dated August 19, 1985 and have been designated by Joseph N. Klingensmith, Radiation Safety | |||
{f jp3 g | |||
tai Y Officer. l* | |||
8806160422 971031 i | |||
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1 | |||
;pwrhwww-a?u:s:wama im mL M EwtrzeL u wmer 3c q m eturessm miu:q U.S. NU R REGULAT8RY COMMISSION PAGE OF PACES k 4 | |||
*N R C F or m 3 7 4 A LMnse nzmber > | |||
SNM-1319 h | |||
$.1 . M ATERIALS LICENSE ,g , y | |||
, SUPPLEMENTARY SHEET > | |||
4 . | |||
070-01342 Y | |||
'4 k | |||
* g CORRECTED COPY Amendment No. 21 >4 4 | |||
p)i l4-(11. continued) CONDITIONS h 8 | |||
j C. The Radiation Safety Officer for this license is Joseph N. Klingensmith, fg l 12. As six month intervals the 1icensee shall collect and tally data from all medical institutions with respect to: (a) accountability, removal and recovery, pp q | |||
4 (b) duration of satisfactory performance or the time of service before malfunction, h l$ and (c) nature of malfunction (if appropriate) of all implanted Coratomic Model & | |||
i C-100, C-101, and C-101P nuclear-powered pacemakers. Within ninety (90) days of the lp six month peri 0d ending February 28 or August 31, a copy of the report shall be sent l to the U.S. Nuclear Regulatory Commission,; Region I, Nuclear Matericls Safety p 4 | |||
'4 Section, 631 Park Avenue, King of Prussia, ' Pennsylvania 19406. | |||
4 | |||
>k k | |||
: 13. This license does not authorize the implantation of pacemakers into humans or 4 | |||
animals. p q | |||
: 14. A(1) Any sealed sources or detector cells specified in items 7.A and 7.B shall be p; p | |||
3 9 | |||
tested for leakage and/or contamination at intervals not to exceed 6 months. jkj i Any source or detector cell' received from another person which is not g 3 accompanied by a certificate indicating that.a. test was performed within g* | |||
4 6 months before the transfer shall not be put-into use until tested. | |||
Q (2) Notwithstanding the peric,dic k leak teit required by this condition, any 3 licensed sealed source or' detector;celliis exempt from such leak tests i when the source or detector cell' contains 100 microcuries or less of beta and/or gamma emitting material'or'10 microcuries or less of alpha emitting | |||
;4 material. g% | |||
. pl QI B. Any sealed source or detector cell in storage and not being used need N 3 | |||
i not be tested. When the source or-detector cell is removed from storage j f | |||
st for use or transfer to another person, it shall be tested before use or transfer, y | |||
g q! pj 4 | |||
k C. The test shall be capable of detecting the presence of 0.005 microcurie ' | |||
bi | |||
$ of radioactive material on the test sample. If the test reveals the >; | |||
1l presence of 0.005 microcurie or more of removable contamination, the E | |||
,i source or detector cell shall be removed from service and decontaminated, f | |||
.! repaired, or disposed of in accardance with Commission regulations. A p1 | |||
'i report shall be filed within 5 days of the date the leak test result is $ | |||
hj known with the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief. ti 4 Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of t 4l! Prussia, Pennsylvania 19406. The report shall specify the source involved, E i4 the test results, and corrective action taken. Records of leak test results shall be kept in units of microcuries and shall be maintained for hl p' | |||
4l 4 inspection by the Commission. Records may be disposed of following p Commission inspection. > | |||
'il l ?l W' | |||
. M; i, | |||
l4i h 4 | |||
l4 b'652CrassmTsm%TsTmTsaamT&TaTaam%Taxaam?_ tat.TmT&TsamanTaL%T i | |||
ue u c Ic o e a | |||
("O uun,e nurnder & | |||
4 SNM-1319 h 4 | |||
. ,M ATERIALS LICENSE t>ocket or Reference nun.ber h" Q'4 | |||
* FUPPLEMENTARY SHEET 070-01342 d | |||
i CORRECTED COPY Amendment No. 21 lN i | |||
4 (14. continued) CON 0lT10NS li l | |||
4 i C. Tests for leakage and/or contamination shall be performed by the licensee j or by other persons specifically licensed by the Commission or an Agree- ! | |||
l ment State ta perform such services. l, 4 ;- | |||
4 | |||
: 15. The licensee may transport licensed material in accordance with the provisions y, of 10 CFR Part 71, "Packaging and Transportation of Radioactive Material". l4 i | |||
N j 16. The licensee stiall conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license. Records h | |||
g 4 | |||
'a of inventories shall be maintained for 2 years.from the date of each inventory. E i>j 4 | |||
: 17. Except as specifically provided otherwise in this license, the licensee shall 3 | |||
$ conduct its program in accordance with the statements, representations, and {yl procedures contained in the documents including any enclosures, listed below, p The Nuclear Regulatory Corrmission's regulations shall govern unless the state- p | |||
'4 is 4 | |||
ments, representations and procedures in the licensee's application and corre-spondence are more restrictive'than the regulations. | |||
N A. Application dated May 2,1985 f B. Letter dated August 1.9, 1985 h | |||
3 Letter dated July 10,-1986? #, | |||
4 C. | |||
'i D. Letter dated July 15, 1987= . N E. Letter dated August 11, 1987 g V | |||
l4i 4 E! | |||
,4l i h | |||
h h d | |||
'q! | |||
4! | |||
l4l | |||
@i | |||
!b | |||
,4 i,tF 9 !>I 4 | |||
'4 N | |||
M P | |||
0 il ij | |||
'41 Y For the U.S. Nuclear Regulatory Conmission >} | |||
E h | |||
Original Signed By: | |||
Jenny M. Johansen | |||
)g i | |||
p By jpj l | |||
'lOdte I Nuclear Materials Safety ano lW Safeguards Branch, Region I | |||
*l King of Prussia, Pennsylvania 19406 'N} | |||
b | |||
,l dT.T.nv.TamT_TJnT.T.%Td_nT.TaviTMtvaznTamTmTa;rMaimTsir/raTmT. Tar;rarcr.T;T.TerNi | |||
\ | |||
__}} |
Revision as of 14:25, 17 December 2020
ML20155F539 | |
Person / Time | |
---|---|
Site: | 07001342 |
Issue date: | 10/31/1987 |
From: | Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
To: | |
Shared Package | |
ML20155F542 | List: |
References | |
NUDOCS 8806160422 | |
Download: ML20155F539 (3) | |
Text
._ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
^
?
CORRECTE0 COPY klS. NUCLEAR REGULATORY COMMISSION PAGC [_ OF 3 PAGES
- q ts-s o MATERIALS LICENSE Amendment No. 21 Pursu;nt to the AtonQ Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10.
Code of Federal Regulations, Chapter I, Paris 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations f heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p N l source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to h' 1[% deliver or transfer such material to persons authorized to receive it in accord.uee withj i the h license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and .sj i subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect aad to any l l
(! conditions specified below. i Lt r Licensee l In accordance with letter dated
]i j
- 3. fulge 15 a nuab"1987, I
Biocontrol Technology, Inc. SNM-1319 is amended in i its entirety to read as follows:
g ,
2' s P.O. Box 434 - , 4. Expiration date Indiana, Pennsylvania 15701 September 30, 1990 q
- 5. Docket or gj g Reference No. 070-01342 ad
!4l 6. Byproduct, source.and/or 7. Chemical and/or physical 8. Maximum amount that licensee 3l>
h special nuclear material form may possess at sny one time /
under this license l A. Plutonium (Principal A. Sealed sources A. Not to exceed 250 l l% cadionuclide Pu-238) ~(Pl.utonium batteries) milligrams of Pu-238 per sealed source; 290 grams l4 j{
- i x total
,i B. Plutunium 238 B. Sealed neutron source B. 4.73 curies i i -(Monsanto) (275 milligrams) ;
i vi ,
! l !
- 9. Authorized use lpl
,d
%y$A. (1) For use as a component in assembled Coratomic Model C-101 pacemakers and as a l l
{9 component in the assembly (manufacturing) of Coratomic Model C-101-P i pacemakers; for distribution to medical institutions authorizea to receive y
h[4 Id
! pacemakers pursuant to the terms and conditions of a specific license issued by the Nuclear Regulatory Commission or an Agreement State. pl 1
54l '
,i (2) For recovery as a component of explanted Coratomic Model C-100, C-101 and j C-101-P pacemakers transferred from specific licensees. l i
i
,l (3) For storage or disassembly and re-furbishing of the battery source from i)p Coratomic Model C-100, C-101 and C-101-P pacemakers. p l N P
>{j B. For use as a calibration source.
I Y,*
l CONDITIONS l
Licensed material shall be used only at the licensee's facilities, 300 Indian .
l10. Spring Road, Indiana, Pennsylvania.
lt l'
A. Licensed material shall be used by, or under the supervision of, individuals l$11. l who have completed the training program as outlined in the letter dated August 19, 1985 and have been designated by Joseph N. Klingensmith, Radiation Safety
{f jp3 g
tai Y Officer. l*
8806160422 971031 i
. . - k .. k L - _----.-_-.okld REG 1 LIC70 Ihi $T U s __ SNM-1319 PDR _ - . _ _ ltlk A U EWaT&TEETEAL ATATTATEAl llamTEEEEEEsammmuwwtEAT.TEEEEJ
1
- pwrhwww-a?u
- s:wama im mL M EwtrzeL u wmer 3c q m eturessm miu:q U.S. NU R REGULAT8RY COMMISSION PAGE OF PACES k 4
- N R C F or m 3 7 4 A LMnse nzmber >
SNM-1319 h
$.1 . M ATERIALS LICENSE ,g , y
, SUPPLEMENTARY SHEET >
4 .
070-01342 Y
'4 k
- g CORRECTED COPY Amendment No. 21 >4 4
p)i l4-(11. continued) CONDITIONS h 8
j C. The Radiation Safety Officer for this license is Joseph N. Klingensmith, fg l 12. As six month intervals the 1icensee shall collect and tally data from all medical institutions with respect to: (a) accountability, removal and recovery, pp q
4 (b) duration of satisfactory performance or the time of service before malfunction, h l$ and (c) nature of malfunction (if appropriate) of all implanted Coratomic Model &
i C-100, C-101, and C-101P nuclear-powered pacemakers. Within ninety (90) days of the lp six month peri 0d ending February 28 or August 31, a copy of the report shall be sent l to the U.S. Nuclear Regulatory Commission,; Region I, Nuclear Matericls Safety p 4
'4 Section, 631 Park Avenue, King of Prussia, ' Pennsylvania 19406.
4
>k k
- 13. This license does not authorize the implantation of pacemakers into humans or 4
animals. p q
- 14. A(1) Any sealed sources or detector cells specified in items 7.A and 7.B shall be p; p
3 9
tested for leakage and/or contamination at intervals not to exceed 6 months. jkj i Any source or detector cell' received from another person which is not g 3 accompanied by a certificate indicating that.a. test was performed within g*
4 6 months before the transfer shall not be put-into use until tested.
Q (2) Notwithstanding the peric,dic k leak teit required by this condition, any 3 licensed sealed source or' detector;celliis exempt from such leak tests i when the source or detector cell' contains 100 microcuries or less of beta and/or gamma emitting material'or'10 microcuries or less of alpha emitting
- 4 material. g%
. pl QI B. Any sealed source or detector cell in storage and not being used need N 3
i not be tested. When the source or-detector cell is removed from storage j f
st for use or transfer to another person, it shall be tested before use or transfer, y
g q! pj 4
k C. The test shall be capable of detecting the presence of 0.005 microcurie '
bi
$ of radioactive material on the test sample. If the test reveals the >;
1l presence of 0.005 microcurie or more of removable contamination, the E
,i source or detector cell shall be removed from service and decontaminated, f
.! repaired, or disposed of in accardance with Commission regulations. A p1
'i report shall be filed within 5 days of the date the leak test result is $
hj known with the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief. ti 4 Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of t 4l! Prussia, Pennsylvania 19406. The report shall specify the source involved, E i4 the test results, and corrective action taken. Records of leak test results shall be kept in units of microcuries and shall be maintained for hl p'
4l 4 inspection by the Commission. Records may be disposed of following p Commission inspection. >
'il l ?l W'
. M; i,
l4i h 4
l4 b'652CrassmTsm%TsTmTsaamT&TaTaam%Taxaam?_ tat.TmT&TsamanTaL%T i
ue u c Ic o e a
("O uun,e nurnder &
4 SNM-1319 h 4
. ,M ATERIALS LICENSE t>ocket or Reference nun.ber h" Q'4
- FUPPLEMENTARY SHEET 070-01342 d
i CORRECTED COPY Amendment No. 21 lN i
4 (14. continued) CON 0lT10NS li l
4 i C. Tests for leakage and/or contamination shall be performed by the licensee j or by other persons specifically licensed by the Commission or an Agree- !
l ment State ta perform such services. l, 4 ;-
4
- 15. The licensee may transport licensed material in accordance with the provisions y, of 10 CFR Part 71, "Packaging and Transportation of Radioactive Material". l4 i
N j 16. The licensee stiall conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license. Records h
g 4
'a of inventories shall be maintained for 2 years.from the date of each inventory. E i>j 4
- 17. Except as specifically provided otherwise in this license, the licensee shall 3
$ conduct its program in accordance with the statements, representations, and {yl procedures contained in the documents including any enclosures, listed below, p The Nuclear Regulatory Corrmission's regulations shall govern unless the state- p
'4 is 4
ments, representations and procedures in the licensee's application and corre-spondence are more restrictive'than the regulations.
N A. Application dated May 2,1985 f B. Letter dated August 1.9, 1985 h
3 Letter dated July 10,-1986? #,
4 C.
'i D. Letter dated July 15, 1987= . N E. Letter dated August 11, 1987 g V
l4i 4 E!
,4l i h
h h d
'q!
4!
l4l
@i
!b
,4 i,tF 9 !>I 4
'4 N
M P
0 il ij
'41 Y For the U.S. Nuclear Regulatory Conmission >}
E h
Original Signed By:
Jenny M. Johansen
)g i
p By jpj l
'lOdte I Nuclear Materials Safety ano lW Safeguards Branch, Region I
- l King of Prussia, Pennsylvania 19406 'N}
b
,l dT.T.nv.TamT_TJnT.T.%Td_nT.TaviTMtvaznTamTmTa;rMaimTsir/raTmT. Tar;rarcr.T;T.TerNi
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