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It is my first time in the forum, and need urgent help with two questions:
We are doing a gap analysis for 60601-1 Compliance from 2nd to 3rd Edition, and need clarification in two issues:
1. It is my understanding, that for CE marking to the MDD all products need to comply to the Third Edition by June 1, 2012. Additionally, the transition date for equipment that falls under the scope of a Particular Standard is three years after the publication of the applicable standard as a CENELEC EN standard, is this official?
2. Are the IEC 60601-1 collateral and particular standards equivalent to the EN 60601 standards? and, if we are in compliance with IEC Standards can we claim complaince with the EN standards? Thanks
We are doing a gap analysis for 60601-1 Compliance from 2nd to 3rd Edition, and need clarification in two issues:
1. It is my understanding, that for CE marking to the MDD all products need to comply to the Third Edition by June 1, 2012. Additionally, the transition date for equipment that falls under the scope of a Particular Standard is three years after the publication of the applicable standard as a CENELEC EN standard, is this official?
2. Are the IEC 60601-1 collateral and particular standards equivalent to the EN 60601 standards? and, if we are in compliance with IEC Standards can we claim complaince with the EN standards? Thanks