Fwd: CDRH Updated Performance Standard Diagnostic X-Ray

[Ccja@aol.com]

---------------------
Forwarded message:
From:	mikeg@SLAC.STANFORD.EDU (Mike Grissom)
Sender:	medphys@LISTS.WAYNE.EDU (Medical Physics Listserver)
Reply-to:	MEDPHYS@LISTS.WAYNE.EDU (Medical Physics Mailing List)
To:	MEDPHYS@LISTS.WAYNE.EDU (Multiple recipients of list MEDPHYS)
Date: 97-11-03 11:47:53 EST

Medphys'ers,

The following extract from the CDRH update to the August
1,
1997 subject document (update dated October 30, 1997) may
be viewed in
its entirety at the following Web URL:


       http://www.fda.gov/cdrh/teprssc.html

----------

  Concepts for
Proposed Amendments to the Performance
         Standard for Diagnostic
X-Ray Systems

                     August 1, 1997

       Center for
Devices and Radiological Health
               Food and Drug
Administration

Comments may be sent to:

        Center for Devices and
Radiological Health
        Mail Code HFZ-140
        5600 Fishers Lane

       Rockville, Maryland 20857

Concepts for proposed amendments to the
performance
standard for diagnostic x-ray systems.

CDRH is proposing to
develop amendments to the Performance
Standard for Diagnostic X-ray Systems
and their Major
Components (21 CFR 1020.30 - 1020.33) to address
changes in
the technology and clinical application of
radiographic and fluoroscopic
x-ray systems. Concepts for
the amendments are described below with a brief
rationale
for each amendment and with a very preliminary first draft
of
potential wording for some of the amendments. The draft
wording is provided
only for the purposes of discussion
and should not be interpreted at this
stage as indicative
of the final approach which may be taken with
any
particular amendment. These concepts for amendments were
discussed with
the Technical Electronic Product Radiation
Safety Standards Committee, an
advisory committee the FDA
at the committee's April 8, 1997 meeting.
Interested
parties are invited to comment on the need for and content
of
possible amendments to the performance standard to
address these areas in
response to an Advanced Notice of
Proposed Rulemaking which will be
published in the
Federal Register in the near future.

Topics for which
amendments are proposed and the affected
sections of 21 CFR 1020.30 -
1020.33:

        1. Conversion to SI quantities and units for the

          entire standard.
        2. Clarification of applicability of
requirements
           to account for technological developments

          such as digital imaging, digital recording, and

          solid-state x-ray imagers.
        3. 1020.30(h) Amendment to
incorporate draft
           Compliance Policy Guide on Information to be

          Provided to Users.
        4. 1020.30(m) Requirement for increased
HVL.
        5. 1020.32(b)(2)(v) Requirement for improved x-ray

          field limitation.
        6. 1020.32(g) Clarification on minimum
source-to-skin
           distance for mini-C-arm systems.
        7.
1020.32(h) Requirement for indication of
           cumulative time of
patient irradiation.
        8. 1020.32(j) Requirement for
"last-image-hold"
           feature.
        9. 1020.32(k) Requirement for
display of air kerma
           rate and cumulative air kerma.

....[much
detail follows]...


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