The FDA does look over the shoulder of pacemaker manufacturers to check
their immunity performance. They test to AAMI standards and to their own
internal
standards, with many of the tests being performed at levels from 100 to 200
Volts per meter.
TUV Product Service in St. Paul MN does a great
Hello Group,
I am in the midst of evaluating the compliance status of a
particular product for a potential OEM relationship. This product is a
standalone box with Ethernet ports powered by an external AC adapter with an
output of 7VDC. The adapter is NRTL Listed, IEC 950 CB report,
From: plaw...@west.net (Patrick Lawler)
To:emc-p...@majordomo.ieee.org
Subject: Re: EN 55024 Question
Date: Thu, 24 Jun 1999 17:02:22 GMT
Reply-to: plaw...@west.net (Patrick Lawler)
On Wed, 23 Jun 1999 11:54:25 +, Geoff Lister
Martin,
Check out http://www.fda.gov/cdrh/devadvice/dd_asist.html
http://www.fda.gov/cdrh/devadvice/dd_asist.html
I am not aware of any emission requirements. On occasion when the 510K is
submitted and reviewed the FDA will sometimes request emissions testing. If
it never finds its way into
As far as I am aware, the FDA requirements (21CFR) relate to the emission
of X-rays from CRTs within monitors. We always state that any LCD displays
within our products are therefore exempt from the FDA requirements.
I also have on file a letter to all manufacturers and importers of
television
Martin, I have to say that I don't even know what you mean by FDA emission
guidelines. Please elaborate.
My company has installed electronic business equipment in hundreds of
hospitals and medical facilities and we have never been asked to comply with
FDA emission guidelines. Our equipment
When producing equipment that uses flat screen (LCD) 1/4 VGA displays,
is there any requirement to meet FDA emission requirements (overall
equipment is not for medical use, and would never find its way into a
hospital environment).
I only ask as one of my collegues is quite insistent that we
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