IEC 60601-1:2005/AMD2:2020 — Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
Summary
The core safety standard for all medical electrical equipment (ME equipment). IEC 60601-1 specifies general requirements for basic safety and essential performance, covering electrical hazards, mechanical hazards, radiation hazards, electromagnetic compatibility, temperature limits, accuracy of controls, and programmable electrical medical systems. This is the most widely applied standard in the medical device industry for any device powered by electricity.
Standard Details
- Standard Number: IEC 60601-1:2005+AMD1:2012+AMD2:2020
- Type: IEC 60601 Series
- Published by: IEC
- Official Link: https://webstore.iec.ch/en/publication/2606
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.
Document Details
Document IDIEC 60601-1:2005+AMD1:2012+AMD2:2020
TypeIEC 60601 Series
AuthorityIEC
Publication Date2020-01-01