Lately the EN 60601-1, “Medical electrical equipment. General requirements for basic safety and essential performance,” has been getting revised on a regular basis. Part of the reason is that the source standard, IEC 60601-1, has been updated. So the European adoption over time is republished to keep pace with the IEC changes. Let’s talk about some of the recent updates, what they contain, and your purchasing options from Document Center Inc.
The latest edition of EN 60601-1 was released in 2006. Your first update was in May of 2011, the implementation of IEC corrigenda December 2006 and December 2007 and the implementation of CENELEC corrigendum March 2010 (modification of CENELEC Foreword and Annexes ZA and ZZ.)
The second update was released in February of 2012. This was the implementation of CENELEC amendment A11:2011, when Annex ZZ was replaced by Annexes ZZA and ZZB.
Then in December of 2012, IEC amendment 1:2013 was implemented with the released of CENELEC endorsement A1:2013. Annex ZA was also replaced and Annex ZZ was added.
Now, the latest revision from this month (November 2014) implements the IEC corrigendum July 2014 (Figure 12 has been updated.) And the CENELEC amendment A12:2014 has also been implemented. This means Annex ZZ has been updated to Annex ZZA, with the previous Annex ZZA being deleted. And a new Annez ZZB has been inserted. So, in this new edition your Annexes are:
- Annex ZA, “Normative references to international publications with their corresponding European publications.”
- Annex ZZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices.”
- Annex ZZB, “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices.”
FYI: These Annexes comprise 31 pages of material at the beginning of the BS EN 60601-1 edition.
What are your purchasing options? Here at Document Center Inc. we offer you two choices for ordering this new update. In the BS EN 60601-1 edition, you’ll need to buy the entire document as a reprint, with all of your changes interfiled into one new publication. With the SIS EN 60601-1 (the Swedish Edition in English), you can purchase just the amendment. However, this means that you’ll only have the changes noted in your copy, so you’ll have to make pen and ink changes to your original edition by hand. None-the-less, it is far less expensive to purchase just the amendment than the consolidated reprint from BSI.
You’ll be able to order the BS EN 60601-1 edition at our webstore, www.document-center.com. You can also purchase the SIS EN 60601-1, but for the amendment only, you’ll first request a quote. Our staff will confirm the price of the document and that you understand you’re purchasing just the amending material. You might also want to consider contacting us directly by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to assist you with any conformance documentation issue you may have. Make us your Standards Experts!
