ML011570508
| ML011570508 | |
| Person / Time | |
|---|---|
| Issue date: | 06/06/2001 |
| From: | Samson Lee NRC/NMSS/IMNS/MSIB |
| To: | |
| References | |
| SSD 00-20 | |
| Download: ML011570508 (5) | |
Text
Application and Review Checklist for Acceptance Review for SSD 00-020
SUMMARY
DATA Name and Complete Mailing Address of the Applicant:
GE Medical Systems P.O. Box 414, NB-917 Milwaukee, WI 53201-0414 Name, Title, and Telephone Number of the Individual to Be Contacted If Additional Information or Clarification Is Needed by the NRC:
James Beebe 262-785-5381 (voice) 262-785-8250 (fax)
The Applicant is (check one):
If the Applicant Is Not the Manufacturer, Provide the Name and Complete Mailing Address of the Manufacturer:
ELGEMS, Ltd P.O. Box 170 Tirat Hacarmel 30200 Israel Custom User Manufacturer X
Distributor Manufacturer and Distributor If the Applicant Is a Custom User, Provide the Name and Complete Mailing Address of the Distributor:
Provide the Name, Complete Mailing Address, and Function of Other Companies Involved:
Model Number: CoDe AC Principal Use Code (see Appendix E):
Name Used by the Industry to Identify the Product (e.g., Radiography Exposure Device, Teletherapy Source, Calibration Source, etc.):
Medical Radiography For Use by:
X Specific Licensees Only General Licensees Only Both Specific and General Licensees Persons Exempt from Licensing Leak-Test Frequency:
Principal Section of the 10 CFR that Applies to the User (e.g., General Licensees under 10 CFR 31.5): 10 CFR 32, 35 Periodic Leak-Testing is Not Required X
6 Months Radionuclides and Maximum Activities (including loading tolerance):
16.5 mCi Attached is justification for a leak test frequency of greater than 6 months CERTIFICATION:
THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT.
THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT, NAMED IN ITEM 2, CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10, CODE OF FEDERAL REGULATIONS, PARTS 30 AND 32 AND THAT ALL INFORMATION CONTAINED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF.
WARNING: 18 U.S.C. SECTION 1001 ACT OF JUNE 25, 1948 62 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.
Certifying Officer Typed Name and Title Signature:
Date:
CHECKLIST Registration Certificate Holder:
Model:
DESCRIPTION OK/DEF COMMENTS DESCRIPTION/CONSTRUCTION If registration certificate holder is requesting to register more than one source/device on a certificate, are designs similar enough to do so?
NA Device/source design with complete engineering drawings (dimensions, tolerances, list of materials)
Def Assembly methods (screw, welds, etc.);
verify integrity x
Source mounting (size and integrity) and security x
Is source classification sufficient (ANSI N43.6 or ISO 2919)?
Radiography - Unprotected............................ 43515 Radiography - In Device.............................. 43313 Medical - Radiography................................ 32312 Medical - Teletherapy............................... 53524 Medical - Brachytherapy............................... 53211 Medical - Source Applicators........................... 43312 Gauges - Unprotected.............................. 43333 Gauges - In Device................................. 43232 Gauges, Low Energy Gauges, or X-ray fluorescence...... 33222 Oil Well Logging.................................... 56522 Portable Moist/Density................................ 43333 Neutron Applications................................. 43323 Calibration source activity > 30µCi (1 MBq)............... 22212 Irradiators (I)...................................... 43323 Irradiators (II, III)................................... 43424 Irradiators (II, III, IV)................................. 53424 Chromatography..................................... 32211 Static Eliminators.................................... 22222 Smoke Detectors.................................... 32222 43333 Definition of shutter operation (locked in Off position, not locked in On position), Fail safe, spacing and tolerances x
On-Off indicators (description, qty., location) x Safety interlocks, guards, etc. to prevent access to beam or high radiation levels Def Corrosion between unlike materials (e.g., aluminum & steel, depleted uranium & steel, etc.)
x Shielding efficiency and integrity x
For medical devices: Was a 510(k) provided? (provide written notification to FDA)
Def Well logging sources must be nondispersible and nonsoluble. (see App. B for a list of approved well logging sources as of Nov. 1991)
NA See ANSI and Other Standards list for references for particular source/device designs (e.g. radiography, Brachytherapy, etc.)
NA
CHECKLIST Registration Certificate Holder:
Model:
DESCRIPTION OK/DEF COMMENTS LABELING Copy of label x
Materials, dimensions, colors (note on registration certificate if labeling is exempt from the color requirements of 10 CFR Part 20) x Permanent attachment and location(s) - visible to users?
x Contents: Model#, Serial#, Isotope, Activity, Manufacturer, Date of Assay, Trefoil, CAUTION - RADIOACTIVE MATERIAL (Depleted Uranium information must be included) x CONDITIONS OF USE Expected working life of the source/device (years, operations) 10 yrs Actions to be taken when product reaches end of its working life.
x Maximum allowable temperature, vibration, shock, corrosion, etc.
(during use, handling, storage, and transport) x How the device will be used x
Meets dose limits of Part 32 for distribution general licensees or persons exempt from licensing NA PROTOTYPE TESTING/HISTORICAL USE Def 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.
RADIATION PROFILES Def Survey instrument used (type, window thickness, sensitivity, etc.)
Conditions: including environments, scatter (product in beam), and use of guards and shields Distance from source/surface (per ANSI 538-1979)
Shutter Open and Closed/Source Shielded Verify radiation surveys for radiation meet inv2 law.
Verify radiation surveys for non-radiation have not been calculated using inv2 law.
CHECKLIST Registration Certificate Holder:
Model:
DESCRIPTION OK/DEF COMMENTS QUALITY ASSURANCE Def Materials, subassemblies, services Assembly methods (screws, welding, etc.)
Dimensions and tolerances Activity, radiation levels, leak tests QA Manual and comparison of manual to Regulatory Guide 6.9 INSTALLATION Fixed, portable, movable, fixed installation but portable source housing x
Inherent shielding, inaccessibility x
Beam access: size of air gap/opening to beam and use of interlocks, locks, additional shielding or barriers x
Mounting integrity x
SAFETY INSTRUCTIONS Operation, maintenance, calibration, damage/failure, specific warnings, leak test, and radiation surveys x
ACCOMPANYING DOCUMENTATION Leak tests results and radiation surveys x
Transportation documents x
Operation, maintenance, calibration, damage/failure, specific warnings, leak test, and radiation survey instructions if applicable x
For Distribution to General Licensees:
Verify NRC Regions and Agreement State listing is up-to-date and copies of all pertinent regulations x
CHECKLIST Registration Certificate Holder:
Model:
DESCRIPTION OK/DEF COMMENTS SERVICING The following activities may be performed by the persons indicated:
Activity by a General Licensee Only by a Specific Licensee Will be Offered by the Applicant Installation X
Relocation X
Maintenance X
Repair X
Source Exchange X
Calibration X
Leak Testing X
Radiation Survey X
Training X
FOREIGN VENDORS Drop ship Who and where is source installed Leak test and radiation surveys QA in the U.S.
Def Signature:
/RA/
Date: 05/15/00 K:\\Document Processing Center_Ascent\\ADAMSP8-2039\\downloads\\001 - 100\\046\\ML011570508.wpd