ML20134C138

Responds to 940728 Application Requesting Device Evaluation & Registration of an Exempt E Distribution License for 500S & 200P Series Smoke Detectors

ML20134C138
Person / Time
Issue date:	02/09/1995
From:	David Tang NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Markwell S AFFILIATION NOT ASSIGNED
Shared Package
ML20134B972	List: ML20134C027 ML20134C051 ML20134C079 ML20134C100 ML20134C122 ML20134C124 ML20134C138 ML20134C152 ML20134C157 ML20134C200 ML20134C781 ML20134C784
References
SSD, NUDOCS 9701310257
Download: ML20134C138 (2)

Text

. _ . . _ _ _ _ _ . __ . . . . . _ _ _ _.__m . . _ . . _ . . . _ _ . . . - . -__ _

p ara p \ UNITED STATES i g j NUCLEAR REGULATORY COMMISSION

o WASHINGTON, D.C. 20666 0001

+

l

', ****+g February 9, 1995 1

Mr. Scott N. Markwell Sleepsafa Corporation-2121 Electric Road Roanoke, Virginia 24018

Dear Mr. Markwell:

,i This letter is in response to your application dated July 28, 1994, requesting a device evaluation and the registration of an exempt "E" distribution license 1

e for the 500S and 200P series smoke detectors. We are in the process of evaluating the information submitted in your report, " Application for Device Review." However, we need the following additional information and clarification to complete our evaluation: I i

1. Demonstration that the quality control (QC) program implemented by your manufacture contractor (s) meets the requirements of 10 CFR 32.26(b)(15) and as further discussed in Appendix C of Draft Regulatory Guide DG- 1 6002. Please discuss Sleepsafe's quality assurance (QA) program to I

ensure that activities performed by other companies as discussed in i Section 3.1.5 of the Application for Device Review (ADR) will meet your

{ quality standard. Please also send in the QC procedure manual as stated j in page 13 the ADR. The procedure manual should also denote the sample sizq and its justification for meeting the "SSSS" position on quality control. Copies of selected regulations and the draft Regulatory Guide are enclosed.

2. Results of prototype testing done on the detector. Please provide results of prototype testing of the detector, including drop tests, as stated in pages 7 and 12 of the ADR. These tests must be performed, in accordance with 10 CFR 32.26(b)(11) and (12), to demonstrate the effectiveness of the constructio9 and design of the containment, shielding, and other safety features of the detector.

3. Designandconstructionoftheionizationchambhtodenyhumanaccess to the sealed source. Paragraph 32.26(b)(7) of-10 CFR Part 32 requires the applicant to address the degree of access of human beings to the product during normal handling and use. In Fig. I of the ADR, please .

clarify how will the screw hold together the ionization chamber, the PCB, and the source cup. Also please explain how and where soldering will be applied to deny human access to the sealed source through non-destructive means. An enhanced version of Fig. I or equivalent will be useful.

p..M 9701310257 951025 PDR RC

• SSD PDR t _ _ __ _ . _

Mr. S. Markwell '

4. Analysis to meet radiation safety criteria of 10 CFR 32.27. Section 3.3.6, " Radiation Profiles," of the ADR provides estimates of external doses and dose commitments under various scenarios. We assume that you used the information contained in NUREG/CR-1775 and NUREG/CR-1156 to arrive at the numbers to calculate doses. 'If this is not the case, please so indicate and provide basis for these numbers.

Please provide the requested informat' ion as soon as possible. If you have any  :

questions, please contact me at (301) 415-S$7.S or Mr. Steven Baggett at (301) 415-7273.

g Sincerely, i

'MSidied by David T. Tang, Mechanical Engineer Sealed Source Safety Section {

i Source Containment and Devices Branch  !

Division of Industrial and l Medical Nuclear Safety  !

Office of Nuclear Material Safety I and Safeguards

Enclosures:

(1) Regulatory Guide 10.10 (2) Selected regulations I (3) Draft Regulatory Guide DG-6002 DJstribution:

SSSS Staff SCDB r/f NE01 550-@-W DOCUMENT NAME: G:\MARXWELL.DTT Ta receive a sepy of tM2 docuaent,Indcate in the hex: "C" = copy without ettechment/encloswo *E* = Copy with attachment / enclosure "N* = No copy l0FFICE SCDB lc- SCDB m, .

l l l lNAME DTang/dt/tk g SBagdittt l0 ATE 2/ @/95 2/ l /95 5

0FFICIAL RECORD COPY I

i i

I i

I

!