This standard specifies a procedure by which manufacturers can determine the hazards associated with medical devices and their accessories (including in vitro diagnostic medical devices), estimate and evaluate the 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 to be used for clinical judgment related to the use of medical devices. It does not prescribe acceptable levels of risk. This standard does not require manufacturers to have an appropriate formal quality system in place. However risk management can be an integral part of the quality system.
YY/T 0316-2003 history
2016YY/T 0316-2016 Medical devices.Application of risk management to medical devices
2008YY/T 0316-2008 Medical devices.Application of risk management to medical devices
2003YY/T 0316-2003 Medical devices-Application of risk management to medical devices