Historical
DIN EN ISO 14971:2020
Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic (IVD) medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all stages of the life-cycle of a medical device.
Content Provider
Deutsches Institut für Normung [din]
