IEC 82304-1:2016 — Health software — Part 1: General requirements for product safety
Summary
Applies to the safety and security of health software products designed to operate on general computing platforms (e.g., mobile apps, cloud-based health software). IEC 82304-1 addresses the full product life cycle including design, development, validation, installation, maintenance, and disposal. Particularly relevant for standalone Software as a Medical Device (SaMD) products.
Standard Details
- Standard Number: IEC 82304-1:2016
- Type: IEC Standard
- Published by: IEC
- Official Link: https://webstore.iec.ch/en/publication/24671
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 82304-1:2016
TypeIEC Standard
AuthorityIEC
Publication Date2016-10-01