This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD.
This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile.
What’s The Big News About?
On 16 May 2014 the Official Journal of the European Union (OJEU) published an updated Harmonized Standards List for the MDD 93/42/EEC (2014/C 149/02), therefore making it a Harmonized Standard under the MDD. Of the five changes to the list for “first publication” documents the one of concern for this post is EN 60601-1:2006 + A1:2013 (it is also known as Edition 3.1 which means 3rd edition of EN 60601-1 [published 2006] + Amendment 1 (or A1) [published 2013]). The cessation of presumption of conformity for the EN 60601-1:2006 (3rd edition without A1) has been set to be 31 December 2017 ( a 3 year transition period) but there is more to the picture so please read on otherwise you will run into a problem before that date.
Remember That Harmonized Standards Are Voluntary:
NOTE: A reminder that EU Harmonized Standards are not mandatory to meet the Essential Requirements of the MDD but do help make it easier to meet the Directive than going it without the use of Harmonized Standards typically but it is your choice how to approach this issue. I do recommend, to my clients, that they use Harmonized Standards, when they can, since they are common standards that Notified Bodies and Test Houses understand and are familiar with. So, it is easier to use a Harmonized Standard like EN 60601-1 than to prove, with a higher burden of proof, using a different standard(s) or internal specification(s), etc. that the Notified Bodies may not be as familiar with and then the manufacturer has a higher bar to prove to the Notified Body to prove they meet the Essential Requirements of the MDD.
What’s That Note All About?
In the recently released OJEU Harmonized Standards Listing for EN60601-1:2006+A1:2013 there is an extensive note that discusses the dates of cessation which reads verbatim:
“Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.”
What’s The Bottom Line?
So, what does the above text really mean? You will need to consider the A1 Annex ZZ before the end of the transition period for the standard EN60601-1:2006 (3rd edition). The EN60601-1:2006 transition period ends on 31 December 2017 but on 1 January 2016 you will need to comply, if using this voluntary standard, with the clauses of Annex ZZ of EN60601-1:2006+A1:2013 to be provided with the presumption of conformity that is needed to help meet the essential requirements of the EU Directive in relation to the EN60601-1 standard.
To learn more about the Annex ZZ refer to the 2nd post in the below listing of past posts on the 60601-1 standard.
How Many Changes Are There in A1:2013 of EN 60601-1:2006 + A1:2013?
There are quite a few changes in A1 as there are 496 changes that were brought into the standard. Why so many changes? The original 3rd edition of the standard was released before it may have been totally ready but after about 10 years of development the standard committee decided they needed to get something out before the project would have been sent back to the drawing board (meaning it could have taken another couple years to release it) by IEC rules and also because at that point there was so much anticipation of the release by industry and the Test Houses the standard committee decided it was mature enough to get it out the door. Of the 496 changes only about 70 of the changes are moderate to significant impact and the rest are editorial and minor corrections including typo corrections too.
For easy reference we have listed below some of our past posts on 60601-1 and 3rd edition + A1 which may be of interest to you.
- Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1
- Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ
- FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032
- IEC TR 62348:2012 Added in Assessment of impact of most significant changes of IEC 60601-1:2005 Amendment 1 (This Technical Report talks about the significant and moderate changes to the standard of the 496 changes that were made to the standard.)
- When will IEC 60601-1:05+A1:12 turn into EN Standard?
- IEC 60601-1:2012 Consolidated 3.1 Edition Just Published
- Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC