Historical
OVE/ONORM EN ISO 14971:2020
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
This document defines terminology, principles, and a process for the risk management of medical devices, including software as a medical device and in vitro diagnostics. The process described in this document is designed to help medical device manufacturers identify the risks associated with the medical device, assess and assess the risks involved, manage those risks, and monitor the effectiveness of risk management measures. The requirements of this document apply to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as biocompatibility risks, data and system security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are used in some areas of responsibility .
Content Provider
Austrian Standards Institute [on]
