IEC 62366-1:2015/AMD1:2020 — Medical devices — Application of usability engineering to medical devices

Specifies a process for manufacturers to analyze, specify, design, verify, and validate usability as it relates to the safety of medical devices. IEC 62366-1 covers the usability engineering process, including use specification, user interface design, formative evaluation, and summative evaluation (human factors validation testing). Critical for demonstrating safe and effective use of medical devices.

Standard Details

• Standard Number: IEC 62366-1:2015+AMD1:2020
• Type: IEC Standard
• Published by: IEC
• Official Link: https://webstore.iec.ch/en/publication/67220

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.