ML20199E583

Corrected Page 3 to Registry of Radioactive Sealed Sources & Devices Safety Evaluation of Device for Model SI Series. Certificate:NR-355-D-106-E

ML20199E583
Person / Time
Issue date:	12/23/1997
From:	Steven Baggett, John Lubinski NRC
To:
Shared Package
ML20199E492	List: ML20199E490 ML20199E501 ML20199E563 ML20199E569 ML20199E583 ML20199E601 ML20199E618 ML20199E649 ML20199E654 ML20199E660 ML20199E672 ML20199E705 ML20199E714 ML20199E771
References
SSD, NUDOCS 9802020199
Download: ML20199E583 (10)

Text

..

JAN. 6.1998 6 0 CPM HCCHIKI ft1 ERICA CORP l0.677 P.2/2 i

4

' REGISTRY OF RADI0 ACTIVE SEALID SOUltCES AND DRVICIE SAFETY EVALUAT1' N OF DRVICE MCt.,1 NR-355-D-10'6 E Dh211 December 23, 1997-M 3 0F. 3 pavica Tvani. smoke Detector n=maarecimri feane e st Hochiki distributes these' devices under different trade names, consequently, the deteetors may have ditferent product codes listoaonthepointot}salelabeling'(seetablebelow).

sechiki-Riseplex -

Radiantos SIH 24F 2098-9576 or.

D281 :

2098-9550 **-

81H.24FAP' NA i

NA S!J.24 NA i'

NA

• • The 2098-9550 la identical mechanically and in sensitivity to the 2098 9576 with the exception of the cooxy encaosulated orinted circuit board used in the 2098-9550, marnaquena, The fo11'owing supporting documents.for the smoke detector models SI series are hereby incorporated by.ruference and are made a part of this registry document, i

e Nochiki America Corporation's application dated May 2,.1997, facsimiles dated June it,-1997, December.1, 1997, and December 4, 1997,!and letter dated August 4, 1997, with

. enclosures thereto, IsaDING AGEMcY, U.S. Nuclear Regulatory Commission.

/

Date:

nA a*

• 22. 1997-Revieweri John W..Lubinski j

Date~

Bea ^ r 22. 1 et concurrence st.v. n. a.ssett i

I 9802020199 980108 PDR RC PDR SSD

.a Source / Device Review Checklist MANUFACTURER / DISTRIBUTOR: kBC b

1. 28 R GISTRATION #:

/8X MODEL #:

N

\\cr'Ut3

REFERENCES:

DESCRIPTION OK/DEF COMMENTS FIRST PAGE Registrant's name and address v

Manufacturers and distributors name and address du e M b'"# - A X-Custom users name and address

/

b Model number

/

Type (from Reg. Guide 10.10 or 10.11) f Users authority to possess (specific, general, both, exempt)

N

/

Radionuclides, activity (Max w/% error), form, f

g/My /pp //

BfpC manufactu er, model, NRC registered y

(note on registration certificate if source is registered gi//

N'8g as part of the device)

Leak test frequency no periodic leak hst for; krypton-85, tritium, radioactive gas, isotopes with half-lives of 30 days or j

less, beta-or gamma-emitting material of no more r/

than 3.7 MBq (100 microcuries), or alpha-emitting material of no more than 370 kBq (10 microcuries).

Greater than 6 month frequency:

use criteria in 10 CFR 32.51(b) or 32.74(b)(1)

DESCRIPTION / CONSTRUCTION f h, < n.',,,,JM If registrant is requesting to register more than one source / device on a certificate, are designs similar enough to do so?

Device / source design with complete engineering drawings (dimensions, tolerances, list of materials)

Assembly methods (screw, welds, etc.);

verify integrity

5 DESCRIPTION OK/DEF COM.*AENTS Source mounting (stre and integrity) and security V

i is source ANSI classification sufficient:

Radiography - Unprotected - 43515 Radiography - In Device

-43313 Medical-Radiography

- 32312 Medical-y Teletherapy

- 53524 y Gauges - Unprotected

-43333 y Gauges -In Device

-43232 p Gauges, Low Energy y Gauges, or X-ray fluorescence

- 33222 Oil Well Logging

- 56522 Portable Moist / Density

- 43333 Neutron Applications

-43323 y Irradiators (11, Ill, IV)

-43424 y Irradiators (1)

-43323 Static Eliminators

- 2222

/

g 3;-340f VM-Smoke Detectors (32222 gq)

(from ANSI N542-1977) 8' Definition of shutter operation (locked in Off position, not locked in On position), Fail safe, spacing and bN tolerances On-Off indicators (description, qty., location) 17[A Fafety interlocks, guards, etc. to prevent access to j

beam or high radiation levels Corrosion between unlike materials (aluminum &

j steel, depleted uranium & steel, etc.) see " Corrosion" information Shielding efficiency and integrity For medical devices - was a FDA 510k provide?

g/g (provide written notification to FDA) t Welllogging sources must be nondispersible and i/

nonsoluble. (see Appendix H for a list of approved f

wel!!ogging sources)

See " ANSI and Other Standards" list for references.

for particular source / device designs (e.g. radiography, Brachytherapy, etc.)

r DESCRIPTION OK/DEF COMMENTS RADIATION PROFILES Survey instrument used (type, window, sensitivity, y

etc.)

" snditions

/

Distance from source / surface gr ANSI 538-1979)

Shutter On and Off/ source shielded f//N Scatter (product in beam)

A/A Guards and shields in place

/

Verify radiation surveys for y radiation meet inv law.

/

2 Verify radiation surveys for non-y radiation have not

///4 2

been calculated using inv law.

4 QUALITY ASSURANCE Materials, subassembl!as, services P

'I Asserri;/ methods (screws, welding, etc.)

Dimensions and tolerances Activity, radiation levels, leak tests QA Manual INSTALLATION i

Fixed, portable, movable, fixed installation but portable source housing

/gf Q. g

.cg g d

y Inherent shielding, inaccessibility v'

interlocks, locks, barriers

/

Beam access: size of air gap / opening to beam (verify size with new GL rule)

Mounting integrity f///

L-.

n DESCRIPTION OK/DEF COMMENTS

.:. u.

LABELING i~ca, rA +r{Al/d X

Copy of label 4

Nahm

1. g,gf1 7 Materials, dimensions, colors (note on registration

-j gct, (<f certificate if labeling is exempt from the color V

requirements of 10 CFR Part 20) 4 U II" "

'k /*%.

)(

I Permanent attachment and location (s) - visible to

/-

users?

Contents: Model#, Serial #, Isotope, Activity,-

Manufacturer, Date c." Assay, Trefoil, " CAUTION -

j RADIOACTIVE MATERIAL"(Depleted Uranium information must be included)

CONDITIONS OF USE Expected working life of the source / device (years, f

jg operations)

Actions to be taken when product reaches end of its working life.

Maximum allowable temperature, vibration, shock, corrosion, etc. (during.use, handling, storage, and transport)

How the device will be used V

Meets dose limits of Part 32 for G and E distribution E '/

PROTOTYPE TESTING / HISTORICAL USE Tests methods and conditions (for source and device)

Tests results Years of use (incidents, failures, etc.)

Similarities to other sources / devices if they are used as basis.

4 I

4 DESCRIPTION OK/DEF COMMENTS SAFETY INSTRUCTIONS Operation, maintenance, calibration, damage / failure, specific warnings, leak test, and radiation surveys ACCOMPANYING DOCUMENTATION Leak tests results and radiation surveys fl//[

Transportation documents h//

Operation, maintenance, calibration, damage / failure, specific warnings, leak test, and radiation survey instructions if applicable For GL dist.

Verify NRC Regions and Agreement

/U State listing is up-to-date and copies of all pertinent regulations SERVICING Manufadurer provides or user performs:

/ installation Calibration Relocation Leak Test v', Maintenance Radiation Survey Repair Training Source Chancellnstallation FOREIGN MANUFACTURERS Drop ship

'Vho and where is source installed Leak test and radiation surveys QA in the U.S.

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