IEC-82304-1
Health software — General requirements for product safety
Safety requirements for health software products not embedded in medical devices. Covers standalone health applications including mobile health apps, clinical decision support, and health IT systems.
- Document
- IEC 82304-1:2016
- URL
- https://webstore.iec.ch/en/publication/25786
- Label
- Standard
- Keywords
- health software standalone software mobile health clinical decision support health IT product safety SaMD
Domain: Medical · Standard