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 devices

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2018 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.

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