YY/T 0316-2016: Translated English of Chinese Standard. (YYT 0316-2016, YY/T0316-2016, YYT0316-2016): Medical devices - Application of risk management to medical devices2018 M01 26 - 110 pages This Standard specifies a process for a manufacturer to identify the hazards (sources) 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. |