SIST-TP CEN ISO/TR 24971:2020

Oznaka standarda: SIST-TP CEN ISO/TR 24971:2020
Koda projekta: JT003055
Organizacija: SIST
Naslov (angleški): Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Naslov (slovenski): Medicinski pripomočki - Navodilo za uporabo ISO 14971 (ISO/TR 24971:2020)
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SIST-TP CEN ISO/TR 24971:2020 angleški jezik Active SIST-M: 119.79 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 11.040.01
Status: Objavljen
Objavljen: 01-sep-2020
Refer. št. objave: Sporocila 2020-09
Referenčna oznaka: CEN ISO/TR 24971:2020
Področje projekta (angleško): This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide[25].

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