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CEN ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

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Kehtiv alates 03.08.2020
Alusdokumendid
ISO/TR 24971:2020; CEN ISO/TR 24971:2020
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03.08.2020
Põhitekst
CEN ISO/TR 24971 provides guidance to assist in the development, implementation and maintenance of a risk management process for medical devices. CEN ISO/TR 24971 provides guidance on the application of ISO 14971 for a wide variety of medical devices. These medical devices include active, non-active, implantable, and non-implantable medical devices, software as medical devices and in vitro diagnostic medical devices. CEN ISO/TR 24971 describes approaches that manufacturers can use for a risk management process conforming to ISO 14971. When judging the applicability of the guidance in CEN ISO/TR 24971, you should consider the nature of the medical devices to which it will apply. Consider how and by whom these medical devices are used, and the applicable regulatory requirements. The same structure and numbering of clauses and subclauses as in ISO 14971 is employed to facilitate the use of CEN ISO/TR 24971. The text of ISO/TR 24971:2020 has been approved in Europe as CEN ISO/TR 24971:2020 without any modification.
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