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EN ISO 14971:2019/A11:2021 Standard

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  Keywords:

#eu #relationship #a11 #found #can

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Wednesday 5th of July 2023

  Description:

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

  Purpose

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 EN ISO 14971 and the General Safety and Performance Requirements of Regulation (EU) 2017/745.— Annex ZB covers the relationship between EN ISO 14971 and the General Safety and Performance Requirements of Regulation (EU) 2017/746.

  Publication

Thursday 12th of May 2022

  Amendment

This standard is an amendment for "EN ISO 14971:2019"

  Related Standards

EN ISO 13485:2016

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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 11135:2014

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EN ISO 11135:2014/A1:2019

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EN ISO 11737-1:2018

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Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

EN ISO 11737-1:2018/A1:2021

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Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

EN ISO 11737-2:2020

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Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

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