Summary

Specifies usability requirements for medical electrical equipment within the IEC 60601 framework. References IEC 62366-1 for the detailed usability engineering process and applies it in the context of ME equipment safety.

Standard Details

Standard Number: IEC 60601-1-6:2010+AMD1:2013+AMD2:2020
Type: IEC 60601 Series
Published by: IEC
Official Link: https://webstore.iec.ch/en/publication/2591

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.

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IEC 60601-1-6:2010/AMD2:2020 — Medical electrical equipment — Part 1-6: Collateral standard: Usability

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