Confused: IEC 60601-1-2:YYYY and Required Compliance Dates

qu1nn

Involved In Discussions
#1
Hello,


Reference Link
Is it me or is the setup (and notes) of the Office Journal for the harmonized standards falling under medical devices just plain confusing with regards to when conformity to a particular spec is REQUIRED?

Question 1) Is it still acceptable to have a product on the market (that was tested by a main test house in June 2007) which lists that the standard used for EMC was EN 60601-1-2:2001?



On another note:
From my understanding compliance with:
EN 60601-1-2:2007 and 60601-1:2006 will be required june 2012 (assuming all of the 61000 series can be updated)... is this correct?

Thanks for your time
qu1nn
 
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Marcelo

Inactive Registered Visitor
#2
Standards are voluntary, they are not "required".

Please see further discussions in this topic: http://elsmar.com/Forums/showthread.php?t=37925

Anyway, you can have a product which complies with an old version of a harmonised standard IF your risk management shows that all the risks are managed in the same level and thus you still comply with the essential requirements; in practice this is a little more difficult because notified bodies tend to rely on standards and standards revisions for control.
 
N

nikolaos

#3
IEC / EN 60601-1-2:2007 describes the same test levels so there in no update test necessary, unless your risk management changes the essential performance criterions or the compliance levels, in this case retest is required.
 

qu1nn

Involved In Discussions
#4
Thanks for the responses. Sorry for the delay...

so basically i can still make use of the (2001) without physical retesting as it is at the same test levels, AND I can still make use of that date listed as a referenced in my Essential Requirements Report as long as I add a blurb stating the reasoning. The original essential requirements report made use (and references) the Risk Management 14971(2007) and was in full effect at the time of its writing.

Question 1:
With regards to the original question is the harmonized standard listing for the MDD confusing with regards to the presumed compliance dates or is it me?

Question 2:
SO what date did presumption of conformity for 60601-1-2(2001) end?

Question 3:
Am I correct that presumption for conformity for 60601-1-2(2007) and 60601-1:2006 will be required june 2012 (assuming all of the 61000 series can be updated)?

thanks for your time
qu1nn
 
Last edited:

Marcelo

Inactive Registered Visitor
#5
1 - your original question was: "plain confusing with regards to when conformity to a particular spec is REQUIRED?". The point is, conformity is not required. I´m not sure if it was confusing because of that. Anyway, what is confusing is the date of cessation of presumption of conformity of the old standard..i think this is what you were talking about.

Tha date on the column "Date of cessation of presumption of conformity of superseded standard" is the date that any claim of compliance with the old version (this old veersion is the one appearing in the column Reference of superseded standard) was or will loose the effect of "presumption of conformity", which is a mechanism of the medical devices directives (and of the whole new approach directives) regarding the using of standards in regulations.

As mentioned in Note 1, generally this is the date of withdraw of the superseded standard, but not always.

Also, what might be confusing you is that the presumption of conformity date is related to the amendments. So, the 01/03/2009 date on EN 60601-1-2:2001/A1:2006 is the date that presumption of conformity with the standard, WITHOUT THE AMENDMENT, cessed.

2 - EN 60601-1-2:2001 + EN 60601-1-2:2001/A1:2006 have no cessation date yet, because the new edition does not have a date. Maybe the FAQ presented here could help in the understanding.

3 - Again, presumption of conformity is not required. You CAN use harmonized standards to CLAIM presumption of conformity if you wish, but you do not have to (although it surely is the easiest method).

Anyway, for the new general standard and new collaterals, June 2012 will be the date, but only after publication in the official journal, which did not happen yet. Also, this date will be set regardless of the update of the whole series. Again, please take a look at the FAQ.
 
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