SSH EN ISO 14971:2019/A11:2021

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

Publication date: Aug 29, 2022

General information

Current stage: 60.60 Effective date: Aug 29, 2022

Originator: DPS

Owner: DPS/KT 316

Type: Pure national standard

ICS: 11.040.01

Languages: English

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Status: Published

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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.

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