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IEC 60601-1-2 4th edition transition deadline Dec 31 2018

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#1
Hi all,

60601-1-2 is transitioning to 4th edition and will be implemented from Jan 1 2019. Are the old products which are already approved under 3rd edition can still continue without transitioning to 4th edition?

Or all the products, no matter what, if they don't have certification to 4th edition can't be sold at all.

Also what world areas are expected to follow this time line since there are still some countries that are on 3rd or even 2nd edition of the standard.

Thanks,
 
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M

MedMartin

#2
Hi,

depends on the market, according to my knowledge:
EU / CE - Medical devices may only be brought into the market if tested to the new standard even if already approved to the 3rd edition.
US / FDA - they allow "grandfathering", already approved devices can still be sold.

I do not know the state in other parts of the world, China is still using the older version of the standard.

Best regards
Martin
 
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