Transcription of IEC General Standard: National Deviations and ... - …
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IEC 60601 -1, Edition 3 and Harmonized Medical Standards (Reference Only, Revision 2017-09-01). [Dates in RED and brackets are deadlines for meeting new Editions of the standards]. International Medical Base Standards IEC General Standard: IEC 60601 -1, Edition (2012-11-14), (2014-07-22), (Project 2019-12), (Project 2024). = IEC 60601 -1, Edition 3 (2005-12) + (2012-07) + IS3 (2013-05). National Deviations and Required Dates: USA: ANSI/AAMI ES 60601 -1:2005(R)2012 (11-2012). = IEC 60601 -1, Edition + US Deviations FDA: Only Edition accepted NRTL Safety Marks: Editions 2, 3, (no cessation dates provided for Edition 2 or 3 yet) Note, some NRTLs are not accepting Edition 2. CANADA: CSA :14 (2014) [2017-03, based on 3 year transition]. = IEC 60601 -1, Edition + Canadian Deviations Health Canada: No. 60601 -1:2014 accepted SCC Safety Marks: Editions 2, 3, (no cessation dates provided for Edition 2 or 3 yet) Note, some SCC labs are not accepting Edition 2. EUROPEAN UNION: EN 60601 -1:2006 + A1:2013 (2013) + Amendment 11 (2011), + Amendment 12 (2014) [2017-12-31].
IEC 60601-1, Edition 3 and 3.1 Harmonized Medical Standards (Reference Only, Revision 2017-09-01) [Dates in RED and brackets are deadlines for meeting new Editions of …
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IEC 60601, Risk Management, Risk Management Guidance, Major IEC 60601-1 3rd Ed changes, 0004-IEC60601 Symbols and Markings, 02 INTERNATIONAL STANDARD NORME INTERNATIONALE, IEC 60601-1: Changes from 2nd, Intertek, New standard for medical beds - EN 60601, 60601, IEC60601, EMD Standard requirements depending from the, IEC 62304