Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requirements

M

MBTEX

#1
I was recently advised by auditor that our current products on the market would tested to IEC 60601 2nd ed. would have to be retested for safety per the 3rd edition. Just trying to get some more opinions on this.

Thanks
Mark
 
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S

SteveK

#2
Re: Current products and IEC 60601 3rd Edition

I was recently advised by auditor that our current products on the market would tested to IEC 60601 2nd ed. would have to be retested for safety per the 3rd edition. Just trying to get some more opinions on this.

Thanks
Mark
Hi Mark,

I have exactly the same worry. As a first off I have conducted a
simple gap analysis between the versions - basically saying no real change (I then put this in the relevant Technical File). Whether this will keep NBs happy I do not know - anyway we have got until 2012! Usual situation though - it's a rip off, if it did not hurt before then what has really changed (strange that lots of NBs are also 60601 test houses!).

Steve
 
M

MBTEX

#3
Re: Current products and IEC 60601 3rd Edition

Ain't that the truth if so just seems like another money grab.

Mark
 

Peter Selvey

Staff member
Super Moderator
#4
Re: Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requireme

Money grab's probably a bit of an overkill, the 3rd edition is causing a some financial pain and internal stress for the test labs as well. Efficient (profitable) testing only comes when things are reasonably predictable, and the 3rd edition is far from that.

But I think there is a more deeper question: is it reasonable? And, if not, what options do manufacturers have?

Recently I stumbled across two legal concepts in Europe: one is legal certainty, and the other is the principle of proportionality. These concepts sit above the regulation, so I think it's possible on both counts to explore the legality of the 3rd edition.

The real situation here is that the 3rd edition was made in all good faith, but there were too many new areas that were taken on, and as a result we have a standard that needs a lot of work (as with any new venture).

To apply such a standard to new designs is perhaps reasonable, because we have to start somewhere, to get feedback on how to improve.

However, to apply such a new and obviously faulty standard in retrospect is clearly out of proportion, and violates the concept of legal certainty.

Are there any manufacturers out there willing to take on the EU high courts?
 
G

Glenn P

#5
Re: Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requireme

The following scenario for your consideration.

If a product has been tested to the 2nd edition and is sitting on a distributors shelf in Europe before June 30th 2012.

Can this product sill be sold/distributed after June 30th 2012?

Thanks
Glenn
 

Peter Selvey

Staff member
Super Moderator
#6
Re: Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requireme

There was a similar issue with the transition to the MDD itself back in the late 90s.

Originally the deadline was 1998 for both "placing on the market" (i.e. advertising etc) and "putting in to service" (actual use). However, the "putting into service" was then delayed to 2001 in the M1 amendment, to allow suppliers to clear their supply chain.

For standards unfortunately there is no such provision. Keep in mind the above extension required modification to the law itself.

In the usual case, from initial publication as IEC or ISO, there is about 5 years to the end of any transition period (7 years in the case of IEC 60601-1). If the standard is reasonable, clear, objective then there should be no problem to meet the deadline including clearing the supply chain. But as parts of the 3rd edition are unreasonable, unclear and subjective everyone has been putting it off until the last minute ...
 
C

CBAL08

#7
Re: Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requireme

Would be helpful to have an overview ofthe change of certificate in following markets

  • Europe and Canada - June 2012
  • USA?
  • ASIA?
 
D

DaGusta

#8
Re: Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requireme

Dear Forum,

regarding the time scheduele of the 3rd. Version:

Extract from a UL letter:

TIMING:
The US FDA has recognized the 3rd edition of IEC 60601 and has identified June 2013 as the
transition date.
Both EU and Canada have recognized the 3rd edition of IEC 60601 and have established a
June 2012 date as the date it will be required.

best regards
daniel
 
D

DaGusta

#9
Re: Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requirements

... and here the link: :)

http ://www. ul. com /global/deu/pages/offerings/industries/healthsciences/606013rded/ - DEAD 404 LINK UNLINKED

best regards
Daniel
 
Last edited by a moderator:
C

CBAL08

#10
Re: Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requireme

Thank you, I could see that the Asian Markets are still to be decided...wanted to know what is going to happen for China, Japan and S.Korea....We are getting the certifcates as per the 3rd edition for our new devices that are to be marketed in Asia . Therefore we were a bit concerned on accepting the 3rd edition. Any help or suggestion on this regards would be highly appreciated.
 
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