YY/T 0316-2016
Medical devices.Application of risk management to medical devices (English Version)
- Standard No.
- YY/T 0316-2016
- Language
- Chinese, Available in English version
- Release Date
- 2016
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 0316-2016
- Replace
- YY/T 0316-2008
- Scope
- This standard specifies a process for manufacturers to identify hazards (sources) associated with medical devices [including in vitro diagnostic (IVD) medical devices], estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of this standard apply to all stages of the medical device life cycle. This standard is not intended for clinical decision-making. This standard does not specify acceptable risk levels. This standard does not require manufacturers to have an appropriate quality system in place. However, risk management can be an integral part of the quality management system.
YY/T 0316-2016 history
- 2016 YY/T 0316-2016 Medical devices.Application of risk management to medical devices
- 2008 YY/T 0316-2008 Medical devices.Application of risk management to medical devices
- 2003 YY/T 0316-2003 Medical devices-Application of risk management to medical devices
