Differences in the requirements between IEC 60601-1 3rd ed. and EN 60601-1:2006

L

Laura Halper

#1
Hi fellow Covers, so glad Elsmar Cove is back!

I am trying to find out if there are any differences in the requirements between IEC 60601-1 3rd ed. and EN 60601-1:2006. Likewise for the collateral standards such as IEC 60601-1-1 and EN 60601-1-1, etc.

Does anyone have a comparison chart or know where I can get one? Or are the requirements the same?

The cost to purchase all of the applicable standards in both the IEC and EN versions is pretty high, especially for small start-up companies with plans to sell in both US and Europe.

Thank you,
Laura
 
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Marcelo

Inactive Registered Visitor
#2
I think the EN version of the Third Edition does not have any differences, at least that's what the initial pages say. However, I do not understand why it does not have the IEC name then.

The EN version of the se ond edition did have 2 differences, in that case it could not use the IEC name.
 

Pads38

Trusted Information Resource
#3
From page 3 of the EN standard:
"The text of the international standard IEC 60601-1:2005 was approved by CENELEC as a European Standard without modification".

Note that 60601-1-1, and -1-4 are, effectively, part of the main standard now.

The EN version does include the (useless) Z annexes.
The Z annexes can, sometimes, be found to be included in the standard "Preview" that several standards publishers provide.
 

Pads38

Trusted Information Resource
#5
Hi Ronen,

When I added the 'useless' comment I was, perhaps, mixing opinion to what was intended as a factual post.

For me it is a significant disappointment that political manoeuvring within various European bodies has resulted in the Z annexes. In my (humble) opinion these serve only to add confusion and take us further away from the day when, hopefully, there will be a single set of requirements for all world trade.
 
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