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Relationship between IEC 60601-1 3rd Ed and IEC 60601-2-10

D

denidebi

#1
We are intending to retest neuromuscular stimulator devices according to harmonized 60601-1 3rd edition when the particular standard 60601-2-10 1st Edition "Particular requirements for the safety of nerve and muscle stimulators" particular standard is not harmonized in 60601-1 3rd edition.
Question is if complying with 3rd edition is required when a particular standard is not harmonized with general standard new revision?
 
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Marcelo

Inactive Registered Visitor
#2
Re: Relationship between 60601-1 3 edition and 60601-2-10

Why do you want to retest to 3rd edition? Meaning, what do you mean as "required"?

If it's for CE marking purposes (might be the case due to your mention of "harmonized standard"), you need to wait for the aligned version of IEC 60601-2-10 to be harmonized (and this can take a while).

Take a look at this document: CLC/TC 62 QUESTIONS AND ANSWERS ON THE EN 60601-SERIES OF STANDARDS IN RELATION TO THE MDD AND AIMD and this thread : Harmonization date of IEC 60601-1 , 3rd Edition
 
D

denidebi

#3
Re: Relationship between 60601-1 3 edition and 60601-2-10

Thank you for a replay. Retesting was requested by Notify Body auditor due a Technical File review. I'm confused. Can we retest by 3rd edition when particular standard isn't harmonized?
 

Marcelo

Inactive Registered Visitor
#4
Can we retest by 3rd edition when particular standard isn't harmonized?
No. As I said before, you need to wait for the aligned version of the particular standardto be harmonized (and this can take a while).
 
D

denidebi

#5
An additional query.
Theoretically, if new edition of particular standard is released before July 2012 (60601-1 mandatory in EC). What is transition period to be in compliance with general and particular standards? Thanks
 

Marcelo

Inactive Registered Visitor
#6
Theoretically, if new edition of particular standard is released before July 2012 (60601-1 mandatory in EC). What is transition period to be in compliance with general and particular standards?
For the MDD, the important date is the date of harmonization (not release - as in it being published) of the standard - when it is published in the official journal. The transition period will usually be given when it's harmonized, in the same "table".
 
M

maracu

#7
Now that the Ed 2 60601-2-10 is about to be voted on, any idea how long before it may be Harmonized and therefore require a neurostimulator to be retested to 60601-1 and 60601-2-10?
 

Marcelo

Inactive Registered Visitor
#8
Now that the Ed 2 60601-2-10 is about to be voted on, any idea how long before it may be Harmonized and therefore require a neurostimulator to be retested to 60601-1 and 60601-2-10?
Really, no. The process of harmonization is really not open (which I think is rather strange) and it may quick (meaning some months after the publication of the En version) or take a while (case of the years between having the old edition as an EN and it being harmonized).

Anyway, if you use 60601 to gain presumption of conformity, you can always test to the new edition of the particular (along with the general and collateral) after it´s published if you want to.
 
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