ISO-14971
Medical devices — Application of risk management to medical devices
The foundational risk management standard for medical devices. Defines a systematic process for identifying hazards, estimating and evaluating risks, controlling risks, and monitoring effectiveness. Referenced by all medical device regulations.
- Document
- ISO 14971:2019
- URL
- https://www.iso.org/standard/72704.html
- Label
- Standard
- Keywords
- risk management medical device hazard identification risk evaluation risk control patient safety benefit-risk
Domain: Medical · Standard