Requirements to Ship Medical Devices to the EU - IEC 60601-1 3rd. Ed.

J

johnq98

To ship product to the EU do we need to comply to IEC 60601-1 3rd ed. and IEC 60601-2-4:2010. I'm aware that IEC 60601-1 3rd. ed a1 has been released and it will go into effect in 1/2013 but will have a 3 yr. adoption.
 
I

isoalchemist

The mandatory date for implementation of the EN European version of the standard is June 1, 2012. The US FDA requires the use of the standard on June 30, 2013, while Health Canada recently extended the required date from June 2012 to April 2013.

Taken from Wikipedia, but it matches up closely with my other information sources. I believe we have had the 3 year transition and these are the final dates.
 
R

Rhino-Bone

That Wikipedia article contains a new date for Health Canada IEC 60601 3rd edition transition that I am not seeing anywhere else on the web.

--> "Health Canada recently extended the required date from June 2012 to April 2013."

The latest guidance I see on the Health Canada website was published last Summer with the title "Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada's List of Recognized Standards." It lists the June 1, 2012 transition date.

Can anyone point to the source of that April 2013 date for Canada?

Thank you for setting me straight!
 
P

Peter Selvey

Leader
Super Moderator
I recently did research for a 3rd edition update presentation and found the same Wikipedia information. But I could not find any back up, including searching the most recent announcements from Health Canada, so I thought it best to ignore.
 
R

Rhino-Bone

Hi Peter! Thank you for sharing your expertise. I feel more solid about the Health Canada date (last summer) rather than the one reported in wikipedia.
:applause:
 
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