IEC-60601-1 › Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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IEC 60601-1:2005+A1:2012+A2:2020 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. This document includes the contents of the corrigenda 1 (2006) and 2 (2007), the contents of the corrigendum to Amendment 1 (2014), as well as the interpretation sheets 1 (2008), 2 (2009) and 3 (2013). This consolidated version consists of the third edition (2005), its amendment 1 (2012) and its amendment 2 (2020). Therefore, no need to order amendments in addition to this publication.
By the way, Committee SC62A (the author of IEC 60601-1 ED. 3.1:2012) recognizes that equipment manufacturers and testing organizations may need a transitional period following publication this type of new, amended or revised IEC publication — both to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. For this reason, the Committee recommends that the content of this publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.
One more thing: If you have the 3.0 Edition, you can order the Amendment 1 and all three Corrigendums. This will be the same as the 3.1 Consolidated Edition with the Corrigendum 1 from November 2012.
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