IEC 60601-1-11:2015/AMD1:2020 — Medical electrical equipment — Part 1-11: Requirements for medical electrical equipment used in the home healthcare environment
Summary
Applies to medical electrical equipment and systems intended for use in the home healthcare environment. Addresses additional safety considerations for non-professional users, including power supply requirements, cleaning and maintenance by lay persons, and environmental conditions typical of home environments.
Standard Details
- Standard Number: IEC 60601-1-11:2015+AMD1:2020
- Type: IEC 60601 Series
- Published by: IEC
- Official Link: https://webstore.iec.ch/en/publication/2596
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 60601-1-11:2015+AMD1:2020
TypeIEC 60601 Series
AuthorityIEC
Publication Date2020-07-01