Re: Cabinet X-ray Systems

["David W. Lee" <lee_david_w@lanl.gov>]

Dan:  Eli is correct.  The FDA (CDRH) has proponency for the federal law
(21 CFR 1020.40) that relates to the manufacture and radiation performance
standards of cabinet x-ray systems.  The radiation safety standard that
these units must conform to, at time of manufacturer, is 0.5 mR in one hour
at 2" (5 cm) from any accessible surface of the "cabinet."  NOTE:  "mR in
one hour" is not necessarily the same as "mR/hr."  Once purchased and in
use, States vary to the extent that they regulate such units.  Many,
however, cite ANSI N43.6 (the updated replacement to the "old" NBS Handbook
114) as a document to be following radiation safety wise.  N43.6 was
published in 1993.  It has new terminology for the various categories of
x-ray facilties.  What NBS Handbook 114 used to call an "Enclosed"
installation, ANSI N43.6 now calls an "exempt shielded" installtion.  It
also states that "cabinet" x-ray systems, manufacturered IAW 21 CFR
1020.40, are essentially "exempt shielded" installations, i.e., those
installations where the exposure rate coming through the shielding
surrounding the x-ray machine (or at the surface of the "cabinet" if you
like) does not exceed 0.5 mR in hour at 2 inches.  REGARDS  David



At 05:55 PM 16-08-97 -0500, you wrote:
>At 05:10 PM 8/16/97 -0500, Dan Marx wrote:
>>What are the current radiation protection regs regarding Cabinet X-ray 
>>Systems, one that would be an "Enclosed System".  I am familiar with the 
>>old NBS handbooks, which are about 25 years old.  Is there anything more 
>>current?
>>
>>Thanks in advance.
>>
>>dan 
>>
>>
>>
>>DAN L. MARX
>>HEALTH PHYSICIST
>>BAKER COLLEGE
>>FLINT MI
>>dmarx01@baker.edu
>>*********************************************************************
>>*********************************************************************
>FDA regulates the manufacturing and distribution of x-ray systems.
>However, the use of cabinet and other x-ray systems, other than by the US
>government, is regulated by the states.  State radiation regulatory
>agencies will supply the current requirements in a state.
>ELI.A.PORT, CHP, CIH, P.E.
>RSSI
>VOICE: 847.965.1999 24X7
>FAX:   847.965.1999
>
>
>
David W. Lee
Los Alamos National Laboratory
Radiation Protection Services Group (ESH-12)
PO Box 1663, MS K483
Los Alamos, NM  87545
PH:   (505) 667-8085
FAX:  (505) 667-9726
lee_david_w@lanl.gov