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EN 60601-1:2006 Edition 2 Update

Mike Schmidt, a medical device consultant that serves as secretary of IEC Subcommittee 62D, Cochair of the AAMI Electrical Safety Committee, sent MD&DI an announcement regarding harmonization of the EN 60601-1: 2006 standard along with the many collateral and particular standards in the 601 series. Schmidt says, "There has been significant concern and discussion about when the 1988 Edition of 60601-1 will be withdrawn, due to  erroneous text in the foreword of the 2006 edition, which indicated this would happen in September of 2009.

CENELEC has finally made an official recommendation for the date to end  the presumption of compliance with the device directives (harmonization) for the second edition." According to Schmidt, the withdrawal date is now officially set for June, 2012. This date aligns the regulatory use of the 60601-1 series in Europe and with the current policy of Health Canada. In the U.S., he says, FDA is expected to recognize the new standard within the next several months. The following link goes to a Q&A document on the CENELEC Web site:

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