Transcription of IEC General Standard: National Deviations and ... - …
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IEC General Standard: National Deviations and ... - …
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.
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 the standards]
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