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IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601-1 (Edition 3.2)

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IEC 60601-1 (Edition3.2)

IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV

Medical electrical equipment - Part 1:General requirements for basic safety and essential performance

IEC 60601-1:2005+A1:2012+A2:2020contains requirements concerning basic safety and essential performance thatare generally applicable to medical electrical equipment. For certain types ofmedical electrical equipment, these requirements are either supplemented ormodified

A copy of thestandard can be purchased here: https://webstore.iec.ch/en/publication/67497

With the publication of IEC 60601-1:2005 + A1:2012 + A2:2020, otherwiseknown as IEC 60601-1 (Edition 3.2), medical device manufacturers must be awareof the varying regulatory transition periods worldwide. Based on experiencewith previous transition periods of international standards around the world,it can be concluded that, as for Amendment 2: 2020 of IEC 60601-1, a transitionperiod will be given of at least 3-4 years in most countries and regions.However, it is also possible that very few countries will require standardcompliance with the predecessor standard (edition 3.1) for longer times. In thegeneral standard of IEC 60601-1 are 78 issues addressed by the amendment2:2020. Further, 32 issues are addressed by several collateral standards such asIEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-10, etc. Beyond that,referenced standards are either completely new or significantly updated, e.g.,IEC 62133-2, IEC 62366-1:2015+A1:2020, IEC 62368-1:2018, ISO 14971:2019. Theparticular standards IEC 60601-2-XY are planned to be published within 2 yearsuntil August 2022, or if the responsible part 2 standard committee will notkeep the date, it will be published by the IEC Central Office in a formal wayonly (update of referenced standards only).

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