Steve,
Everything is negotiable but it sounds like a good approach.
61010-1 is designed for commercial electronic equipment and is adequate for
non-patient connected equipment in most respects. Do you need a single
certification (only CE or US or?) or will multiple certifications (e.g. CE and
US) be needed? Multiple certs complicates the picture slightly as more
standards docs need to be compared but should still work ok.
To determine how much of the present safety certification can be
carried to the new certification, a discussion should be had with the
certifying lab folks; you’ll probably have to work with them to get the
knowledgeable technical folks from each group in the same room go thru the
present report together and agree on what can be used and what is plowing new
ground. (The 2nd project like this will be easier for all concerned; the work
is quite siloed in the test labs.)
For EMC there are probably a couple of options to explore. The
key issue revolves around the fact that medical equipment requires very low
touch current levels compared to commercial equipment so the EMC filters don’t
divert as much current to ground which may leave a messier conducted emissions
level feeding back into the line; what does the commercial market expect in
this regard. As I remember, the 61010 group has written a special EMC standard
for their medical applications as the medical facility doesn’t want to have
non-medical equipment interfere with the medical equipment when operated in the
same environment. Again, you can tear and compare the requirements with the
EMC lab folks and decide what additional testing is needed to cover your bases.
Sounds like and interesting project. Good luck.
:>) br, Pete
Peter E Perkins, PE
Principal Product Safety & Regulatory Affairs Consultant
PO Box 1067
Albany, ORe 97321-0413
503/452-1201
IEEE Life Fellow
IEEE PSES 2020 Distinguished Lecturer
<mailto:[email protected]> [email protected]
Entropy ain’t what it used to be
From: sgbrody <[email protected]>
Sent: Thursday, May 21, 2020 12:16 PM
To: [email protected]
Subject: [PSES] 61010 vs 60601
Fellow gurus,
I have a client who has a product certified to 60601-1 and now they have a
non-medical application and are looking for 61010-1.
Can the medical cert and report be leveraged towards 61010-1 or a new report be
started from scratch?
Same for EMC.
Thanks,
Sent from my Verizon, Samsung Galaxy smartphone
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