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Transition of EN 60601-2-22 ed.2 - Still listed, not expired


Starting to get Involved
It's my understanding that the part 2 standard defines the transition period.

EN 60601-2-22 ed.2 has not expired and remains listed in the OJEU.

IEC 60601-2-22 ed.3 has been out since 2007 but it is still in the approval stage to be harmonized in the EU. I heard that there might be an amendment that will be released by the end of the year, not sure though.

My question is, in this case, if the 2nd edition of EN 60601-2-22 can still be used to claim presumption of conformity to the Essential Requirements (and therefore the 2nd edition of EN 60601-1 can still be used as well)?


The NB-Med guidance on the EN60601-1 implementation indicates in answer 3.5.3: As long as the version of the part 2 which references the 2nd edition is listed in the OJ, then this “old” particular can be used to claim the presumption of conformity.

So in my opinion, the answer is yes. Of course, since the original IEC standard (IEC60601-2-22:1995) is withdrawn by IEC, and IEC 60601-2-22 ed3.1 is out (consolidated with am1:2012) it is wise to anticipate on EN 60601-2-22 ed.2 being removed form the OJ soon. If the standard is important to you, maybe you can try to find out more on the harmonization schedule?


Starting to get Involved
Thanks, that's helpful. I wasn't sure what NB-MED was but I see now that it's a legitimate source. There's also some good info in there about how to handle the transition in the meantime with NB auditors.
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