EN 60601-1-2, “Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests,” has just been updated. The new 2015 Edition is equivalent to the IEC 60601-1-2 Edition 4.0, upon which it is based. The EN 60601-1-2 is part of the harmonized standards list for Directive 93/42/EEC. While the 2015 Edition has not been officially adopted yet (published in the official journal), this should happen soon.
Speaking of dates, one question we often get asked here at Document Center is “When must my transition from the old edition to the new one be completed?” For the EN 60601-1-2, the DOW (Date of Withdrawl of the previous edition) has been extended to 12/31/2018. This is the date when all other national standards within the European Union (including the 2007 Edition of the EN 60601-1-2 and it’s corrigendum) must be withdrawn from usage. You’ll also note that all publications of the European national adoptions (SS EN, DIN EN, and so on) for the new 2015 Edition should be completed by 3/18/2016.
Now, what is included in this new 2015 Edition of EN 60601-1-2? Basically, the text from IEC 60601-1-2 Edition 4.0 has been adopted for use as an EN standard. Some unique features include the addition of a ZA Annex. This Annex states, “When the IEC or ISO standard is referred to in the IEC text standard, this must be understood as a normative reference to the parallel EN standard, as outlined below, including the foreword and the Annexes ZZ.” Yep, you’ll need to be using the EN editions of the referenced documents… And the Annex ZZ from EN 60601-1:2006+A1:2013 applies.
The EN 60601-1-2 also has it’s own Annex ZZ. This describes how conformance to this standard meets the essential requirements of Directive 93/42/EEC. There is a series of 7 notes that preceed the table Z.1. These notes range from the basic disclaimer of the limits of the standard’s scope to the detailed risk management disclaimers of notes 3 and 4. For those of you concerned about the impact of national legislation and other potential variants, note 5 requires that you confirm that such clauses are in compliance with 93/42/EEC yourself.
The Table Z.1 is the actual clause-by-clause review of the standard against the Directive. This is a listing of the Essential Requirements of the Directive 93/42/EEC on the left and the corresponding clauses from EN 60601-1-2 that provide coverage for each. Do note that not all essential requirements are addressed by this standard.
If you need a copy of the EN 60601-1-2 right away, the BS EN 60601-1-2 is currently available. You can search for and order an authorized copy at our webstore, www.document-center.com. Here’s a link directly to the order page for BS EN 60601-1-2. Or contact our staff for more information by phone (650-591-7600) or email (info@document-center.com). We expect other national editions to be available soon.
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