2 years ago, I heard at a TC62 standard committee meeting that due to a lack of availability of Standard Committee members to rewrite the 60601-2-40 according to the structure of the 3Ed, this standard will not be rewritten at all. However, if the standard were rewritten and were finished after June 2012, then the next step would be to transfer it from an IEC standard to an EN standard. The EU transition period of three years starts when it is published as an EN standard. As long as there is a part 2 that is listed in the OJ, which is the case for EN 60601-2-40:1998 at the moment, then this standard gives you the presumption of conformity. If the part 2 is withdrawn by IEC without a replacement, it will also be withdrawn from the OJ list without replacement at some point in time (not necessarily on the same date, however).
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What is current EU thinking regarding 60601-1 Ed2 and Ed3 with regard to EMG machines? 60601-1 Ed2 is dead. 60601-1 Ed3 is current. However, the particular standard for EMG machines (60601-2-40) is aligned with Ed2, and is still on the harmonized standards list.
ReplyDeleteSo the question is, does a new machine need to comply with Ed2 with -2-40, Ed 3, either, or both?