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Emne: Re: [PSES] Medical Device approval for U.S. market
Amund,
It’s not clear whether you are referring just to the safety and EMC
requirements, or all the medical device requirements.
In addition to safety and EMC, you also have requirements in the areas
be more onerous
than stuff for the EU.
The FDA has issued guidance docs for portable equipment.
Brian
From: Amund Westin [mailto:am...@westin-emission.no]
Sent: Thursday, June 11, 2015 6:31 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Medical Device approval for U.S. market
Anyone who can
Anyone who can give me a tip where to start looking for the requirements?
Talking about portable medical equipment, and also for use in vehicles and
aircrafts.
CE Medical Device Directive approval (by a notified body) will be in place
before the U.S. approval project starts.
Regards
The Medical Device Designer’s Guide to IEC 60601-1
From: Brodie [mailto:brodi...@gmail.com]
Sent: Friday, June 12, 2015 6:49 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Medical Device approval for U.S. market
I would recommend you look to the requirements in IEC 60601-1-12 for emergency
I would recommend you look to the requirements in IEC 60601-1-12 for emergency
medical service equipment, as well as IEC 60601-1-11 for the equipment used in
the home healthcare environment. Regards,
Brodie Pedersen
On Jun 11, 2015, at 8:30 AM, Amund Westin am...@westin-emission.no wrote:
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