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.
Basic Data
Standard ID
YY/T 0316-2016 (YY/T0316-2016)
Description (Translated English)
Medical devices - Application of risk management to medical devices
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
11.040.01
Word Count Estimation
76,721
Date of Issue
2016-01-26
Date of Implementation
2017-01-01
Older Standard (superseded by this standard)
YY/T 0316-2008
Regulation (derived from)
China Food and Drug Administration Bulletin 2016 No.25
