IEC 60601-1 3rd Edition Recognition in Canada

A

A.Hedges

#11
Whilst it appears that Canada will continue to accept the 2nd edition of 601. Can anyone help to confirm whether ISRAEL is adopting 601 early.

Committee on Technical Barriers to Trade G/TBT/N/ISR/192 18 January 2008

The new standard replaces SI 1011 part 1 and adopts in full the 3rd edition of future European Standard IEC 60601-1, which will enter into force on July 1st, 2009.
 
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T

Ttraveller

#13
I agree with all that Mike Schmidt mentions in your post (Website) you mention below. I am a convener of 60601-2-58 which is a new std in the 60601 series of standards and so I worked with him as he is the secretary for SC62d (IEC 60601-2-xx stds). Mike does know a lot of the 60601 series and he is correct that once 3rd ed of 60601-1 is applicable in the sepcific areas of the world all those collateral standards immediately apply. So, be careful and do a lot of research on the standards or contact a consultant such as me.
Leo Eisner
 
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W

wrodnigg

#14
IEC 60601-1 3rd Edition harmonized in EC

Btw, the 3rd Ed. is harmonized with the MDD and IVDD from now on.

There is no transition period, it can (must) be applied from now on (if a new part-2 standard is available).l

Also usability engineering (EN/IEC 62366) and lifecycle management for software (EN/IEC 62304) are now mandatory.
 
A

A.Hedges

#15
This message was recieved which confirms the transition.
I would like to re-iterate that manufacturers can claim presumption of conformance using the 3rd ed but this is not mandatory. Please read.


With respect to the 2nd Edition of IEC 60601-1 (EN 60601-1:1990), the listing shows this standard superseded by EN 60601-1:2006, BUT NO DATE OF WITHDRAWAL IS CURRENTLY LISTED. You may recall, the date of withdrawal was originally hypothesized as September 2009. However, it was subsequently proposed by CENELEC Technical Committee 62 that the date of withdrawal for those devices where no particular standard exist be set to two years from the date of publication of the notice in the Official Journal. That would mean the date of withdrawal would be 28 November 2010.
However, as of last Thursday, a claim of compliance with EN 60601-1:2006 now formally give the presumption of conformity with the MDD.
 
T

Ttraveller

#16
Note for the MDD HArmonized Standard List there is a note 1 that applies to all of the standards on the list and it states:
"Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be other wise. "
This means that under the cenelec (the standards organization) website for EN 60601-1 the Date of Withdrawal is Sept 12, 2009 only if the product has no 60601-2-xx std that applies. And so 2nd ed. of IEC 60601-1 will not be withdrawn for many years (approx end of 2010) and it is not mandatory to comply with 3 rd ed (EN 60601-1, 2006) until at least Sept 12, 2009 for the MDD.
Leo Eisner
 
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