Are IEC 60601-1:2012 and BS EN 60601-1:2006+A11:2011 still identical?

ISO 13485 - Medical

Involved In Discussions
can anybody help?

our device is compliant with en60601-1: 2006 (3rd Edition)

when reviewing the standard it says identitical to IEC 60601-1;2005 and BS EN 60601-1:2006

there have has been several new amendments been issued what is the differnce between them are the standards still identical?

IEC 60601-1:2012
BS EN 60601-1:2006+A11:2011
The Amendment 1 to IEC 60601-1, Edition 3
 

Ronen E

Problem Solver
Moderator
can anybody help?

our device is compliant with en60601-1: 2006 (3rd Edition)

when reviewing the standard it says identitical to IEC 60601-1;2005 and BS EN 60601-1:2006

there have has been several new amendments been issued what is the differnce between them are the standards still identical?

IEC 60601-1:2012
BS EN 60601-1:2006+A11:2011
The Amendment 1 to IEC 60601-1, Edition 3

Hi,

Here's my take (not a 60601 expert):

BS EN [something] has to be identical in its normative part to EN [same something]. The ":[year]" bit may differ because typically there's a time lag between issue of the EN version and the member state implementations (BS etc.).

You say that EN 60601-1:2006 claims that it's identical to IEC 60601-1:2005 (3rd edition). I won't argue with that.

As far as I understand, IEC 60601-1:2012 is simply a consolidated version of IEC 60601-1:2005 and its amendment 1 (A1:2012). It's obviously not identical to either IEC 60601-1:2005 (alone), EN 60601-1:2006 or BS EN 60601-1:2006. I think it's also not identical to BS EN 60601-1:2006+A11:2011 -- I don't know this "A11" in particular, but just based on the year of issue.

Bottom line, if you've already addressed amendment 1 (2012) to the 3rd edition, IEC 60601-1:2012 shouldn't matter too much to you. Otherwise, probably best contact your test house to discuss maintaining your compliance.

Cheers,
Ronen.
 

Pads38

Moderator
IEC 60601-1:2005 and BS EN 60601-1:2006 are identical.

Since their publication there has been a couple of corrigenda (corrections to details of the standard) and an Interpretation Sheet.

Then earlier this year IEC published Amendment 1 (a significant document of over 100 pages). There is a consolidated version available from IEC which you may see refered to as IEC 60601-1:2012 or as 60601-1 Ed. 3.1

IEC 60601-1:2005+A1:2012(E) contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. ..... The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008 and the interpretation sheet 2 of January 2009 have been included in this copy.

The latest version of the EU Official Journal (30th August 2012) that is the formal recognition of technical standards does not list the 2012 version or amendment 1. So there is not, yet, an EN version of 60601-1:2012.
 
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