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prSRPS CEN ISO/TS 24971-1:2026

Medical devices — Guidance on the application of ISO 14971 — Part 1: Part 1: General

General information

10.99     Jul 8, 2026

ISS

Z076

Technical Specification

English  

Scope

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, 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.

Life cycle

PREVIOUSLY

PUBLISHED
SRPS CEN ISO/TR 24971:2026

NOW

PROJECT
prSRPS CEN ISO/TS 24971-1:2026
10.99 New project approved
Jul 8, 2026

Related project

Adopted from prCEN ISO/TS 24971-1 IDENTICAL

Adopted from ISO/AWI TS 24971-1 IDENTICAL