60601-1 3rd Edition Compliance with Particular Standards & Equivalency IEC/EN stds

M

meddevsd

#1
It is my first time in the forum, and need urgent help with two questions:
We are doing a gap analysis for 60601-1 Compliance from 2nd to 3rd Edition, and need clarification in two issues:
1. It is my understanding, that for CE marking to the MDD all products need to comply to the Third Edition by June 1, 2012. Additionally, the transition date for equipment that falls under the scope of a Particular Standard is three years after the publication of the applicable standard as a CENELEC EN standard, is this official?
2. Are the IEC 60601-1 collateral and particular standards equivalent to the EN 60601 standards? and, if we are in compliance with IEC Standards can we claim complaince with the EN standards? Thanks
 
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#2
Re: 60601-1 3rd Edition Compliance with Particular Standards, & Equivalency IEC/EN st

1- For CE marking you have to comply with the MDD.
No standards are required.

2 - No
 
M

meddevsd

#3
Re: 60601-1 3rd Edition Compliance with Particular Standards, & Equivalency IEC/EN st

Thank you for your reply Joanne. I understand we need to comply with MDD, but for 60601-1 there are requirements for a transition period for Particular Standards.
 

Marcelo

Inactive Registered Visitor
#4
Re: 60601-1 3rd Edition Compliance with Particular Standards & Equivalency IEC/EN std

Hello meddevsd and welcome to the Cove.

There´s a thread for 3ed harmonization here: Harmonization date of IEC 60601-1 , 3rd Edition, you should take a look.

1. It is my understanding, that for CE marking to the MDD all products need to comply to the Third Edition by June 1, 2012. Additionally, the transition date for equipment that falls under the scope of a Particular Standard is three years after the publication of the applicable standard as a CENELEC EN standard, is this official?

There was a document on the CENELEC website which addressed these things
(QUESTIONS AND ANSWERS ON THE EN 60601-SERIES OF STANDARDS IN RELATION TO THE MDD AND AIMD (http ://www. cenelec .eu /Cenelec/CENELEC+in+action/Horizontal+areas/ICT/Collateral_standards_under_MDD_AIMD.htm - DEAD 404 LINK UNLINKED)

Which is not online anymore.

Anyway, June 2012 is the date for DOCOPOCOSS (date of cessation of presumtion of conformityu of the superseded standard) of equipment which does not have a particular standard (meaning, equipment to which only 60601-1 applies).

Equipment which have a particular will have a transition date depending on the harmonization of the particular. Three years is not a defined date, but is used sometimes.

2. Are the IEC 60601-1 collateral and particular standards equivalent to the EN 60601 standards? and, if we are in compliance with IEC Standards can we claim complaince with the EN standards? Thanks
Usually, but not always.

You can see that on the body (foreword)of the EN standards.

The compliance claim also depends on that. Please note that only EN standards (equivalente or not to IEC) gives presumptions of conformity. For other standards, you do have to justify the equivalent level of safety.
 
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M

meddevsd

#5
Re: 60601-1 3rd Edition Compliance with Particular Standards & Equivalency IEC/EN std

Thank you mmantunes. I was hoping that you will reply to my thread !
I have been reading the forum for a while, but I was not registered. You are awosome! Great to have you knowledge availabe at the forum!
1. Any updated on possible harmonization of 60601-2-24, I believe it will be released in October 2011.
2. Any updates on expected harmonization of 60601-2-49, released on February as IEC 60601-2-49

Look forward to your reply. Thanks so much mmantunes !
 

Marcelo

Inactive Registered Visitor
#6
Re: 60601-1 3rd Edition Compliance with Particular Standards & Equivalency IEC/EN std

Hello meddevsd, and thanks for the kind words.

1. Any updated on possible harmonization of 60601-2-24, I believe it will be released in October 2011.
2. Any updates on expected harmonization of 60601-2-49, released on February as IEC 60601-2-49
I usually have information regarding the international versions of the standards, and general information regarding their use on regulatory systems. I do not know, for example, how and when particular standards will be HARMONIZED, for example, in the EU.

Anyway, please note that, for a standard to be harmonized with the medical devices directives, it has first to be published as an european standard (right now a lot of them are going thru parallel voting so when IEC publishes CENELEC also publishes an european version) and then it has to be accepted as an harmonized standard and then published in the official journal.

Regarding this last action, there´s been some scrutinizing by the EU Commission on IEC standards lately (they have some contracted consulting experts which usually revises the standards looking to determine how they can be used to fulfill essential priniciples) and some problems because some standards where "found" not to fully give presumption of conformity...this has been in priciple delaying their harmonization.
 
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M

meddevsd

#7
Re: 60601-1 3rd Edition Compliance with Particular Standards & Equivalency IEC/EN std

Thank you Marcelo! Great to have your elaborated responses!
 
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