I was asked the following question, and wasn't sure about the answer:

1) A manufacturer can claim his system complies with the Medical Device
Directive by testing to EN 60601-1-2:1993.

2) EN 60601-1-2:1993 does not have any requirements to test to IEC 1000-3-2.

3) Does that mean that the harmonic standard does not apply to this system when
it becomes mandatory in 2001?


I realize the Second Edition of IEC60601-1-2 is just around the corner, and
that edition _does_ call out the harmonic test.  However, I've been told that
it may not take effect until 2003.
--
Patrick Lawler
[email protected]

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