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SSH EN ISO 14971:2019/A11:2021

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Aug 29, 2022

General information

60.60     Aug 29, 2022

DPS

DPS/KT 316

Pure national standard

11.040.01  

English  

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Scope

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 14971:2019

NOW

PUBLISHED
SSH EN ISO 14971:2019/A11:2021
60.60 Standard published
Aug 29, 2022

Related project

Adopted from EN ISO 14971:2019/A11:2021 IDENTICAL

Adopted from EN ISO 14971:2019/A11:2021 IDENTICAL