BS EN 60601-1 for Medical Electrical Equipment has just been updated. The new Edition includes the 2006 revision plus the 3 Corrigenda (12/2006, 12/2007 and 3/2010) and a new Amendment 1 dated 12/31/2013. This is a consolidated Edition. So you’ll need to purchase this complete reprint of the standard with the corrections integrated into the text of the standard.
BS EN 60601-1 is titled “Medical electrical equipment. General requirements for basic safety and essential performance.” It’s among the top standards used to support compliance with the various European Directives that affect medical devices.
Now I’m sure you’re wondering exactly what changes the new amendment and edition bring. Quite simply, the new edition is the adoption of the IEC 60601-1 Amendment 1 from 2012. And as an additional bonus, Annex ZA has been replaced and Annex ZZ has been added.
These Annexes raise a lot of questions for Document Center’s clents. So, for your information, Annex ZA provides the user with a reference table relating the European adoptions to the International level (ISO, IEC) source documents. So, you’ll see a line item with IEC 60079-0 (modified) equating to EN 60079-0 from 2012, and so on.
Annexes ZZA and ZZB still provide you with the information on where the standard does not cover the essential requirements of the EC Directives 93/42/EEC and 90/385/EEC. The new Annex ZZ is a table with the information on the relationship of the EN 60601-1 to each of the requirements of 93/42/EEC. You’ll see a table that has 3 columns, one for the clause of this standard, one for the particular requirement of the Directive, and the 3rd for the coverage the standard provides for that requirement.
This revision is a technical revision, so if you’re certifying to either of these directives and relying on this standard, you’re going to need to purchase the new Edition. And you’ll need to do a thorough review since the new issue is 418 pages compared to the 386 of the 2006/A11 Edition released in February of 2012. Lucky you! The amending material from each of the modifications are marked in the text by tags.
You’ll find this new BS EN 60601-1 2006/A1 Edition will be published throughout the EU by June of next year. The transition date of 12/24/2018 means that the previous edition will be completely phased out in 5 years. Meantime, this new revision does make the previous edition obsolete.
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