ISO/TR 24971:2013
Medical devices - Guidance on the application of ISO 14971
- Standard No.
- ISO/TR 24971:2013
- Release Date
- 2013
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO/TR 24971:2020
- Latest
- ISO/TR 24971:2020
- Scope
- This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. The guidance is intended to assist manufacturers and other users of the standard to: —understand the role of international product safety and process standards in risk management; —develop the policy for determining the criteria for risk acceptability; —incorporate production and post-production feedback loop into risk management; — differentiate between "information for safety" and "disclosure of residual risk"; and —evaluate overall residual risk.
ISO/TR 24971:2013 history
- 2020 ISO/TR 24971:2020 Medical devices -- Guidance on the application of ISO 14971
- 2013 ISO/TR 24971:2013 Medical devices - Guidance on the application of ISO 14971
