ML20197E007
| ML20197E007 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/1996 |
| From: | Charles Brown NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Greene S NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20197B831 | List: |
| References | |
| SSD, NUDOCS 9712290175 | |
| Download: ML20197E007 (2) | |
Text
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9 MEMORANCUM 10: Susan Greene, ticense Reviewer Commercial Section Medical, Academic, and Commercial Use Safety Branch FROM: Christopher L. Brown, General Engineer Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch ,
SUBJECT:
SSD TECHNICAL ASSISTANCE REQUEST: .
El COMPANY LTD.
CONTROL NO. - 021665 i Please find attached the SSD technical assistance request dated August 15,
= 1994. After reviewing the information submitted to date by El Company, we do not have sufficient information to register the device. As per our 't '
discussion, we understand that you intend to void the licensing action, and j will be sendir.g a letter to the licensee to that effect. A draft letter
- containing our concerns is attached for inclusion in your letter. 1 If you have any questions, please contact me at 415-7868 or Mr. Steven Baggett at 415-7273. ,
Attachment:
As stated cc: SKimberley, LFDCB D,is t ribut ion: .
SSSS r/f SSD-94-57 DOCUMENT NAME: C:\SSSS\WORKSSO\EIV010. TAR W " *C'
- COM WMhout eMMhanWneeWe T = Copy w'th attachment / enclosure *N' s No copy 2"_%(IMAB IOFFICE !MO'"."~ada"'it?"[!MAB jd) I b l l l l Jl j (NAME lCBrown/mb ISBaggett ! }
=v=c==jf DATE IO4/ /96 104/ /p /96 - ;
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9712290175 971104 PDR RC
- SSD PDR atto70//3
Mr. Michael Avnet Rt.diation Safety Officer-El Company LTD 7 Cerro Street inwood, NY 11696
Dear Mr. Avnet:
],
This letter is in response to your letter dated October. 11, 1995, regarding registration of the Model Ell 00 BUS, E!!0OSUS, and C1100LUS smoke detectors.
We have requested on several occasions that you provide us with sufficient ,
information to complete the review. Based on the information received from -
you as of your October 11, 1995, letter we still do not have sufficient information to complete the review.' In view of this circumstance and the '
number of requests for information that have already been made to your company, we are unable to keep your request.in an open status. We will keep
-copies of your application on file for one year, during which, you may resubmit your application in its entirety without incuiring additional fees. L Upon receipt of your resubmission, we will reenter your request into the system. ,s
=lf you choose to resubmi'. your request, please include the following: q*,
- l. Please submit dimensions and thickness'of,the printed circuit board, engineering drawings of the base, and method'of installing board into base.- In addition, one of, drawings. indicated a. tamper resistant' screw, "
please explain how it is tamper resistant.
~
- 2. Please provide specific procedures of the-prototype test performed, indicating U e total amount of davices tested, the number of times :,
tested, and the number of devices that'successfully passed a test.
Please verify that the results of your prototype testing will not unly show that the activity is less than 0.005 microcuries, but at the same time demonstrate the effectiveness of the source containment.
- 3. You have made reference to several quality control procedures, but did not include copies with your submission. Please provide this information and demonstrate how the procedures meet the minimum criteria set forth in Appendix C of Regulatory Guide 6.9, " Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material" (anclosed). Please include an explanation of the checks done to ensure design conformity.
- 4. In your letter you stated that you are awaiting a report on external doses and dose commitments. As to date, we have yet to received the report.
We look forward to receiving your resubmission. If you have any questions, please contact me at (301) 415-5787 or Michele Burgess at (301) 415-5868.
, M.
fge eseg%
pl t UNITED STATES
!*' %' j NUCLEAR REGULATORY COMMISS!ON
,e wAsectoN O C. 20h0001 g
j8 June 18, 1997
g 6
Mr. Michael Avnet Hemisphere Forwarding #
7 Cerro Street' j, *
~
Inwood, NY 11696 - .
Dear Mr. Avnet.
This letter is in response to Mr. John Sinnott's letter dated May 27,1996, with enclosures thereto', to M6. Susan Greene, in reference to Models El100 BUS, El100 SUS, and El100LUS. ' '
We are stillin the process of evaluating your request. However, in order to continue our evaluation, the fellowing information is necessary: ,
h.
- 1. Please clasify who the distributer will be: El Company, LTD or Hemisphere Forwarding.
t..
- 2. In accordance with 10 CFR 32 29, the laceic 'or the device and the point of sale ,
package must contain the identification of the person licensed under 10 CFR 32.26 to 1-transfer the detector for use pursuant to 10 CFR 32.20. Your application currently reflects the El Company, LTD as the person to be licensed under 10 CFR 32.26.
(g However,if the distributer is determined to be Hemisphere Forwarding, this company A would then be required to De identified on the label attached to the device and point of i sale package. Please provide tt.e wording of the labels if the distributer is another '{
person other than the El Company, LTD.
- 3. Please demonstrate that the label attached to the base of the device will be visiole wheri 7 ;
removod from its mornting base, j (
- 4. In drawing number D10009, Base - EliOOL, c lists three materials that may be used for (# D the base (! 'Jtyrene Dow ,92U, ABS Cycoisc T 250C, T 27649. and Monsanto ABS ?l 448 & 1% Armostat 575). Which of these materials were used as the base materialin '(
the devices that were used in the prototype testing? For those materials that were not (,
used in the models prototype tested, please demonstrate that these materials would ('j, react in the same or better manner than the material used in the tests. y 5, Does the source manufacturer Nuclear Radiation Developnents Corporation (NRD), k provide the foil source only or does it also insert the foil source into the ion chamber? If j NRD provides only the foil source, then your quality assurance procedure number QP 1.
1027 should be revised to be consistent with Regulatory Guide 6.9, Appendix C. 1 Specifically, each ion chamber should be Icar Msted prior to final packaging instead of f, lot to'erance percent defective (LPD) 5%. Piease provide a revised copy of quality assurance procedure QP 1027.
- 4. Please provide engineering drawings of the cover for each mcdel, including the material of construction and methods of attachment to the bases.
S-C 6 9 n b Q_,,_
1 4
/
's- 'i*
h t
, i' Mr. Sinnott - 2 ,
L5c Your assessment on dose commitments addressing the requirements in 10 CFR 32.27. '
references a report wntten by the National Radiological Protection Board. Board Statoments on Approval of Consumer Goods Containing Radioactive Substances,
' NRPB Volc 3: No. 2,1992. Please provide us a copy of this report so that we can verify the calculations and assumptions made in addressing the requirements in -
- Please provide the requested information as soon as possible. . If I you have any questions, please contact me at (301) 415 5723 or Mr. Douglas Broaddus at (301) 415-5847.
Sincere ,
j' l
i Bria W.- mith. Health Physicist Sealed Source oafety Section 3Aedical, Academic, & Commercial'-
Use Safety Branch Division of Industrial and
' Medical Nuclear Safety, NMSS. ,
+
l.
Distnbution:
- SSSSr/f SSD 96-45 NE01
. DOCUMENT NAME: C:\96 FILES \SSSS\El\El2.DEF To rective a copy of this document, Indicate in the box: "C" = copy without attachment / enclosure "E" = Copy with Ettachment/ enclosure 'Na u No copy j- OFFICE! SSSS , c.
C iMABm , C l f NAME- Brian SmitW DouWittroaddus DATE: 06/fy97 06#6/97 OFFICIAL RECORD COPY ,
- +
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