ISO/TR 24971:2020

Medical devices — Guidance on the application of ISO 14971

Datum objavljivanja: 16. 6. 2020.

Опште информације

Trenutna faza: 60.60 Effective date: 16. 6. 2020.

Inicijator: ISO

Pripada: ISO/TC 210

Vrsta: Tehnički izveštaj

ICS: 11.040.01

Jezik: engleski francuski

Kupovina

Status: Objavljen

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Apstrakt

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].

Životni ciklus

PRETHODNO

POVUČEN
ISO/TR 24971:2013

TRENUTNO

OBJAVLJEN
ISO/TR 24971:2020
60.60 Standard objavljen
16. 6. 2020.

Nacionalna preuzimanja

prSRPS CEN ISO/TR 24971:2025

ISS

Medicinska sredstva - Smernice za primenu ISO 14971

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