Acceptance of IEC EN 60601-1 3rd edition in China

[jmalm]

Hopefully this is a quick answer: our regulatory manager thought China wasn't yet accepting IEC EN 60601 3rd edition as evidence of compliance. Can anyone clarify or provide more information on this front?

 

[Stijloor]

Can someone help?

Thank you!

Stijloor.

 

[Marc]

One more 'Bump' on this one. If any of you can help, my Thanks in advance!

 

[Jamiechina]

Hi, friends. I can give you the answer.
We haven't apply IEC EN 60601.1 3rd edition in China. Now we are using GB9706.1 which was transferred from IEC EN 60601.1 2rd edition.

If you have any other confusion, please don't hesitate to ask me.

 

[jmalm]

Thanks! Is there any expected date when 3rd edition will be adopted?

 

[Jamiechina]

jmalm, I don't think we can adopt 3rd edition in recent 2 years. Becase 2rd edition has just been adopted since 2008.

 

[raqua]

As far as I know, IEC 60601-1 3rd edition is still not accepted by CFDA. Is there any way to avoid that compliance to 2nd Edition has to be shown, if evidence can be provided for compliance to 3rd Edition?

 

[crumble]

hi, do you have any update on this topic? do you know whether China finally recognizes IEC60601-1 3rd edition?

 

[Aubrey Scott]

I would also be interested in knowing just when 60601-1 3rd Edition will be adopted by China. The costs involved in maintaining 60601-1 2nd Edition, on top of 60601-1 3rd Edition are proving too much.

There is much discussion towards dropping 60601-1 2nd Edition.