This standard enables manufacturers to identify hazards associated with medical devices and their accessories, including in vitro diagnostic devices, estimate and assess risks, control these risks, and monitor the effectiveness of those controls. Specify procedures.
JIS T 14971:2003 history
2012JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
2003JIS T 14971:2003 Medical devices -- Application of risk management to medical devices