IEC-62304
Medical device software — Software life cycle processes
Defines lifecycle requirements for medical device software. Classifies software into safety classes (A, B, C) based on the severity of hazard contribution. Specifies processes for development, maintenance, risk management, and configuration management.
- Document
- IEC 62304:2006+AMD1:2015
- URL
- https://webstore.iec.ch/en/publication/22794
- Label
- Standard
- Keywords
- medical device software software lifecycle safety classification risk management configuration management SaMD
- Derived from
IEC-61508
Domain: Medical · Standard