ML20214V545
| ML20214V545 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 10/23/1970 |
| From: | Hixson J MEDTRONIC, INC. |
| To: | US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20197E336 | List:
|
| References | |
| 3495, NUDOCS 8610020331 | |
| Download: ML20214V545 (13) | |
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3055 OLD HIGHnAv EIGH: MthhEAPOLIS MihAE50TA $$418 AREA 61) 701606 '
October 23, 1970 Director
../9 Division of Materials Licensing U.S. Atomic Energy Commission Washington, D. C.
20545 lle: License for Import of Special Nuclear Material and Amendment to Special Nuclear Material License #SNM-1156
Dear Sir:
Medtronic, Inc. submits this application for specific import license and for amendment to the above identified license to handle Special Nuclear Material at our plant located at 3055 Old IIighway Eight in Minneapolis, Minnesota, 55418.
Medtronic requests these licenses to import and possess a.maxLmum of l
tnnaealeisources of Pu238 in thermoelectric _ggnerators produced by Societe ALCATEL of 32 Ilue de Lisbonne in Paris, France. These gen-erators are of the series identified as GIPSIE generators. Each ge_nera-tor contains 2. 5 curies of Pu238 metal cast in the form of a p_ellet. The metal pellet is doubly enca_ sed in a fuel capsule which is shown in attach-ment lil. Each layer of the fuel capsule is hermetically s_ealed by_ electron beam welding and helium lealttested.
This fuel capsule has been subjected to and has withstood the tests required of Special Form Material. A copy of the French government certifications is enclosed as attachment #2. The GIPSIE generator is composed _of_thduel capsulp, a thermoele_ctric_ module and thermal insulation - all hermetically sealed insi_de a titanium _ case. This case, shown in attachment //3, is also hermeticallyy sealed by electron beam welding and_ helium leak _ tested. The GIPSIE generator' case is engraved so as to identify that it contains radio-active materials.
NOV 9 1970 r
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8610020331 860011 Cv0J REG 3 LIC70 PDR SNM-1156 w
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3 The radiation level at the surface of the GIPSIE generators will be ap-proximately 3 mrem /hr when received, and will not exceed 20 mrem /hr C
~k during possession.
Present research programs call for comprehensive electrical testing of these generators after which they are to be packaged in isotopic pulse f
generators. Pulse generators are to be composed of a GIPSIE generator and electronics potted in an insulating epoxy inside a titanium case. (See attachment #4. ) This case is also hermetically sealed by electron beam welding and helium leak tested. The pulse generator case will be engraved so as to identify that it contains radioactive material.
These pulse generators would be used, at present, for bench testing of 1
electrical characteristics and then placed in a saline solution to help de-
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termine their long term performance.
Hadiation protection and source control procedures for these generators
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will be the same as currently used under our license #SNM-1156 No ac-tivity will in any way compromise the integrity of the GIPSIE generator.
Sincerely, MEDTRONIC, INC.
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ln, Joel
. IIirson, Nuclear Engineer and Radiation Safety Officer e
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Borit PourAte N' G 1U 3.055 Old Highway Eight x ^usero.u m w.w 3m V;.. )
0 23
- 7 MINNEAPOLIS, Minnesota 55 41t No9e R(f.
875-1/RB/AC/304 U.S.A.
vone na.e Cher Monsieur, Les sources,de Pu pour stimulateur cardiaque ont satisfait :
- aux essais d6 finis au Journal Officiel de la R6publique Frangaise du 22.11.1967 p.11.368) relatifs aux "Mati6res radioactives sous forme sp6ciale"
- et aux essais recommand6s par l'Agence Europeenne pour l'Energie Nucl6 aire.
Ces diff6 rents essais ont 6t6 effectu6s au Commissariat 5 l'Energie Atomique (Fontenay aux Roses) et a L'Institut des Techniques A6rospatia. 2s (E s pag ne).
Les nouvelles dimensions des sources de Pu pour stimulateur cardiaque ont 6t6 d6finies le 28.5.1970 apras accord entre le Docteur P. IAURENE,
la Soci6t6 ALCATEL et le Commissariat A l'Energie Atomique.
Une s6rie de sources, nouveau modale, a 6t6 envoy 6e le 15.6.197 )
au Laboratoire National d'Essais s Paris, pour v6rification des caractSristiques selon les nonnes internationales en vigueur. Le procSs verbal des essais doit dire remis le 25.9.1970.
La demande d'agr6 ment des sources sous forme sp6ciale scra examin6e le 28.9.1370 s la r6 union de la Commission de Suret6 des Transports.
L'agr6 ment doit intervenir en Octobre 1970.
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Dear Sir:
'Y The 238 Pu sources for pulse generators meet the following requirements:
- the tests on page 11.368 of the Official Journal of /runce of 22 November 1967 regarding radioactive material.
'- the tests as recommended by the European Agency for ;uclear
.:ne rg y.
Those tests are done at the Institute for Atomic Energy (i'on te n a; aux Roses) and a.t the Institute for Space Techniques (Spain).
The new dimensions of the 238 Pu sources are defined on 28 May l _ 70 with approval of Dr. Laurens (Alcatel) and the Institute of
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Atomic Energy.
On 15 June 1970 a series of new sources is sent to the National Laboratory in Paris to verify the characteristics according to the international specs. On 25 September a report of those tests will be ready.
The required approval for the above mentioned sources will be examined on 28 September 1970 during a meeting of the Committee of Transport Security. The approval can be expected in October 197J.
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FO NT EN AY.A U K+RO S E S.
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- Monsieur, ii Ie vous pric de bien vouloir, trouverci-Joint, photocopic du certificat du Ministarc des Transports en dato du 8.10.70 indiquant que 1cc I
d sourcos pour stimulateurs cardiaques, type "ST" sont "agr6cs".
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Copics : M. le Docteur IAURENS M. CAILLOT Soci6t6 ALCATEL l
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M. AIltIS M. THOMAS l
M.IriIEVE l
l M. HIXSON MEDTRONIC U.S.A.
M. le Pr PELLERIN Service Central de Protectica contre les rcyca-nements Ionisants (Ministare cio la Scn:6 c: de
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Vu la Rbclement du 15 avril 1945 pour le transport deo natibreo dancorcucoa par chemina cc fer, par voies de terre et par voloo do naviCation intdrieuro, et particulibrencnt can n o
... ticlo 790 - 2 3 2. iii),
Vu 1%moxo I, dit Rbe;1ement International concernant lo tranaport dca narchandices dancc-rcucca par chemino do for (RID), h la Convention Internationale concernant lo trancporg dca marchandicos par chemins de for, et particulibreacnt con marc. 454 (3),
Yu 18Annoxo A h 18 Accord europ en relatif au transport international dos narchcndicen dan-j corcusca par routo (ADR), et particulibrecent con carc. 2454 (3),
l Vu 18arr$td du 22 noat 1957 concernant le transport par air aca natibroc dancorcucca et it.
rdclementation de 18" International Air 2ransport 1.ccociation" (Il&A) pour lo transport cr 1
cir des articles rJclcmentds (9hmo ddition frangaico,11bso ddition anclaica), et particu-librement le mari;i.nal 6.2.6. do na Pattio 2, 1
I Vu lo Codo Maritimo International dco Marchandioca Dancercucco de 120ran:unaticn ntarccu-vorncmentale Concultativo do la Navication Maritico (CZCI), et particulibrescas 18alinda 2 9. do on clnaco 7, Yu la demando prdoentdo par Ic Cocaincarian h 183ncrcio Atoniauo par lettro c/CT.72 no 70-CG 08 du 29 coptembro 1970 et lo dossier techniquo no 875.1P2/E 324 du 23 9 70 joint L 15appui, tendant h obtenir 18acr6 ment, en ces diffdrontcu variantac, du'modblo do "capculo qui p oc-H ddcrit, constitutivo du codblo do courco acolldo "S2" fabriqudo par la Sous-Jirectica do 14
-Mdtallurcio,
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Ddeido e lo todblo do capculo constitutivo du modblo de ccurce ccelldo ty;e "ST" 1' cur;H Jr w i
cdndratouro d8dnorcio dontindo aux applications addicaloc cat acrdJ ca acc diffdren-too variantoc.
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O October 1G, 1970 Sir:
I ask you to find, attached,-a photocopy of the certificate of the Ministry of Transport, dated -October 8, 1970, indicating that the sources for cardiac stimulators, typo "ST" are " approved."
R. LOUCHER Copics.
- p. 2
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MINISTRY OF TRANSPORTS Department Land Transport Division of Transport of Dangerous Materials.
V CERTIFICATE The Minister of Transports,
' ^
According to the Regulation of April 15, 1945, for the transportation of dangerous materials by railway, by surface routes and by interior navigation routes, and particularly its clause 790 - 2.3.2 iii),
According to Annex I, called International Rcquiation, concerning the transport of dangerous merchandise (commoditie s) by railway (RID),
by the International Convention concerning the transport of merchandise by railway, and particularly its marginal (note) 454 (3),
According to Annex A by European Accord (agreement) relative to inter-national transport of dangerous merchandisc by routo (road) (ADR),
and particularly its marginal (note)- 2454 (3),
According to the decision of August 22, 1957, concerning transport by air of dangerous materials and the strict regulation of thc j
" International Air Transport Association" (IATA) for transport by l
air of the regulated articles (9th French edition; lith English l
edition), and particularly the marginal (note) 6.2.6 of its part 2 l
According to the International Maritime code on Dangerous Marchcadiac of the Intergovernuental Consultative Organization of Maritime Navi-gation (OMCI), and particularly the paragraph 2.9 of its class 7, I
According to the petition (rcquested) by the, Commissariat a 1*Cnergie Atomique by letter S/ CST no. 70-00108 of September 29, 1970, and the technical dossier no. 875.lRB/DL 324 of September 28, 1970 (?) joined in support. and directed toward obtaining consent (approval), in its i
different mod,ifications, of the modul of the capaule which is described there, constitutive of the model of the sealed source "ST" manufactured I
by the Sub-Dopartment of Metallurgy, 3, 900 l
l (It is) decided:
-the capsule model constitutive of the model of the nealed aource type "ST" for micro generators for energy destined for medical appli-cations is approved in its different modifications.
(president of the by the Minister and through
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Commission of Transport 0 ICU"EIO"8
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