BS-EN-60601-1, “Medical electrical equipment. General requirements for basic safety and essential performance,” has just been re-released in a new edition and is now available from Document Center Inc. This British Standard is the UK implementation of EN 60601-1:2006+A11:2011. It is identical to IEC 60601-1:2005. It supersedes BS EN 60601-1:2006, which is to be withdrawn on October 1st, 2014.
Implementation of CENELEC amendment A11:2011 includes the following: Annex ZZ has been replaced by Annexes ZZA, Coverage of Essential Requirements of EC Directives (93/42/EEC), and ZZB, Coverage of Essential Requirements of EC Directives (90/385/EEC). The two new Annexes are informative, each providing illumination on how the standard helps to meet the requirements of the directive noted.
Also, BS EN 60601-1:2006+A11:2011 changes the latest date by which any national standards conflicting with this EN standard have to be withdrawn, making the new due date October 1, 2014.
As noted in previous blogs, BS EN 60601-1 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. It is one of our top-sellers here at Document Center and can be ordered on our website, www.document-center.com. Or order via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here from 6 am to 5 pm Monday through Friday Pacific Time to assist you with all your questions regarding European Standards and Regulations.