Requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. It will represent an evolutionary development of ISO 14971:2007, rather than a break with the concepts used previously. This new version of ISO 14971 will probably be published as ISO 14971:2019. decisions on the use of a medical device in the context of any particular clinical procedure or The third edition of ISO 14971 is now available as a draft (FDIS). The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. Then, EN ISO 14971:2012 was released for the European market only as a version harmonised with. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. When published, ISO 14971:2007 was internationally endorsed. 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.Īpplicable to all phases of the life cycle of a medical device. Specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.
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