-----Original Message-----
From: Dick Grobner
Sent: Wednesday, January 26, 2000 11:19 AM
To: 'Kevin Newland'
Subject: RE: EMC for medical devices
Europe is EN 60601-1-2
In 1996 - for the US - it was the FDA's "draft" document entitled "Reviewers
Guidance for Premarket Notification Submissions" which was in line with the
requirements of 60601-1-2. However it does include a few additional immunity
tests which we have successfully waved with the FDA on past submissions. I'm
not aware of any other US "requirements" regarding EMC & medical equip.
-----Original Message-----
From: Kevin Newland [mailto:[email protected]]
Sent: Tuesday, January 25, 2000 4:09 PM
To: [email protected]
Subject: EMC for medical devices
Hello All,
Could someone let me know the answer to the following
questions please:
1-What are the immunity standards used in Europe for
medical devices?
2-What EMC standards is used in US/Canada for medical
devices?
The product in question is approved for safety to
IEC601-1.
Thank you
Kevin
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