IEC 60601-1-2:2014/AMD1:2020 — Medical electrical equipment — Part 1-2: Electromagnetic disturbances — Requirements and tests
Summary
Specifies requirements and tests for electromagnetic compatibility (EMC) of medical electrical equipment and systems. Covers both electromagnetic emissions limits and immunity to electromagnetic disturbances, ensuring devices operate safely in their intended electromagnetic environment.
Standard Details
- Standard Number: IEC 60601-1-2:2014+AMD1:2020
- Type: IEC 60601 Series
- Published by: IEC
- Official Link: https://webstore.iec.ch/en/publication/2590
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 60601-1-2:2014+AMD1:2020
TypeIEC 60601 Series
AuthorityIEC
Publication Date2020-12-01