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EVS-EN ISO 14971:2019/A11:2021

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

General information

Valid from 15.12.2021
Base Documents
EN ISO 14971:2019/A11:2021
ICS Groups
11.040.01 Medical equipment in general
Directives or regulations
2017/745 Medical devices (MDR) 2017/746 In vitro diagnostic medical devices (IVDMDR)

Standard history

Status
Date
Type
Name
15.12.2021
Amendment
EVS-EN ISO 14971:2019/A11:2021
15.12.2021
Main + amendment
EVS-EN ISO 14971:2019+A11:2021
02.01.2020
Main
EVS-EN ISO 14971:2019

ISO 14971 specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The main text and the consolidated version which consists of main text and the amendment can be found in the standard’s history. EN ISO 14971:2019/A11:2021 modifies the European standard EN ISO 14971:2019. EN ISO 14971:2019/A11:2021 supports the requirements of EU Regulations.

The relationship with EU Regulations can be found in informative annexes:

— Annex ZA covers the relationship between EVS-EN ISO 14971 and the General Safety and Performance Requirements of Regulation (EU) 2017/745.

— Annex ZB covers the relationship between EVS-EN ISO 14971 and the General Safety and Performance Requirements of Regulation (EU) 2017/746.

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EVS-EN 62366-1:2015+A1:2020

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English