ISO 14971:2007
Medical devices - Application of risk management to medical devices
- Standard No.
- ISO 14971:2007
- Release Date
- 2007
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 14971:2019
- Latest
- ISO 14971:2019
- Replace
- IEC 62A/558/FDIS:2006
- Scope
- This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
ISO 14971:2007 history
- 2019 ISO 14971:2019 Medical devices — Application of risk management to medical devices
- 2007 ISO 14971:2007 Medical devices - Application of risk management to medical devices
- 2003 ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
- 2000 ISO 14971:2000 Medical devices - Application of risk management to medical devices
