ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer establishes requirements for the general information that manufacturers have to supply with their medical devices and IVD devices. The authors have succeeded in presenting the criteria in a clear and comprehensible manner. ISO 20417:2021 is also on the list of standards to be…
DetailsIEC 60601-1 describes essential performance as performance necessary to achieve freedom from unacceptable risk. This article aims to explain what the standard means by that and how this essential performance differs from basic safety. The article also addresses the IEC 60601-1/AMD1/ISH1:2021 INTERPRETATION SHEET 1. 1. What is essential performance? a) Definition of the term Despite this definition, there are always…
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