Wednesday, July 22, 2009

EN 60601-1-2:2007, Version required, or not?

EN 60601-1-2:2007 is the Medical electrical equipment collateral standard for Electromagnetic Compatibility requirements and tests, harmonized under directive 93/42/EEC (medical devices).

While this standard has a date of publication of February 1, 2008, it as no fixed date of withdrawal replacing EN 60601-1-2:2001 +A1:2006. Therefore, A1:2006 remains valid until all related part 2-X standards have been withdrawn.

However, when Part 1-2 is used, not in conjunction with a related part 2-x standard, EN 60601-1-2:2001 +A1:2006 has an effective Date of withdrawal (DoW) of September 12th, 2009.

That is to say, compliance must be demonstrated against the 2007 version after 9/12/2009 for appliances not covered under a particular Part 2 standard.

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