Eisner Safety Consultants: Qmed Qualified Supplier

When will IEC 60601-1:05+A1:12 turn into EN Standard?

In the LinkedIn Group – BSI Standards Network – there was this question on 6 Nov ’12: “Does anyone in the group know when the IEC 60601-1-1:2005 +A1:2012 is likely to get turned into a EN by Cenelec?”


As I just read part of a TÜV SÜD E-ssentials e-newsletter – Sept 2012 – I answered the question.  Note, that this question doesn’t ask about Harmonization under the MDD. Note, additional blog posts on Amendment 1 (or A1:12) including A1 of IEC 60601-1:05 (3rd ed.) has been published by IEC (on 13 JUL 2012), IEC 60601-1:12 Consolidated 3.1 ed. Just Published (on 23 AUG 2012), and Update Notice on IEC 60601-1:12 Consolidated 3.1 ed. (on 18 Oct 2012)

“By the TÜV SÜD essentials newsletter Sept 2012 says ‘Experts expect the…A1-EN standard to be published in January 2013.’ Realize this is only an estimate but it does fit within the CENELEC website information which is below:

If you read the cenelec webpage http://www.cenelec.eu/dyn/www/f?p=104:110:2544538240073882::::FSP_ORG_ID,FSP_PROJECT,FSP_LANG_ID:68,23401,25# it sounds like between 17 Nov 2012 (date of announcement = doa) to 17 May 2013 (date of publication = dop) is when the EN version of the standard would be released to the Europan Market place but this may or may not be the same time as when it is Harmonized under the MDD & AIMDD. For the definitions of doa & dop please refer to the lower right hand side of this webpage which gives you these definitions. Also, note that the stage code (or can be said as a progress stage code of the project) is 5091 which means that formal approval will occur but a “decision on voting results (is) deferred (and) advice (is) expected.”