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OVE/ONORM EN ISO 14971:2022
Medical devices - Application of risk management to medical devices (ISO 14971:2019) (consolidated version)
This document determines terminology, principles and a process for risk management of medical devices, enclosed software as a medical device and in-vitro diagnostics. The process described in this document serves to support manufacturers of medical devices, to identify the risk associated with the medical device, to assess and evaluate the associated risks, to master these risks and to monitor the effectiveness of measures to undermine risk. The requirements of this document are to be applied for all phases of the life cycle of a medical device. The process described in this document is to be applied to risks in connection with a medical device, such as risks regarding biocompatibility, data and system security, electricity, moving parts, radiation and usability. The process described in this document can also be applied to products that are not necessarily considered medical devices in some areas of responsibility and it can also be used by others involved in the life cycle of a medical device. This document cannot be applied for: - Decisions on the application of a medical device in connection with a specific clinical procedure; Or - management of business risks. This document requires manufacturers to determine objective criteria for the acceptance of risk, but it does not determine any acceptable risk areas. Risk management can be part of a quality management system. However, this document does not require that the manufacturer has a quality management system.
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Austrian Standards Institute [on]
