Need help?

EN ISO 13485:2016/A11:2021 Standard

wave
Save  

  Keywords:

#requirements #eu #relationship #can #amendment

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 1st of April 2026

  Description:

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

  Purpose

ISO 13485 specifies the requirements of a quality management system for medical devices. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN ISO 13485:2016/A11:2021 modifies the European standard EN ISO 13485:2016. EN ISO 13485:2016/A11:2021 supports the requirements of EU Regulations. The relationship with EU Regulations can be found in informative annexes. In this amendment you can find:— Annex ZA which covers the relationship between EN ISO 13485 and the and the requirements of Regulation (EU) 2017/745.— Annex ZB which covers the relationship between EN ISO 13485 and the requirements of Regulation (EU) 2017/746.

  Publication

Wednesday 5th of January 2022

  Amendment

This standard is an amendment for "EN ISO 13485:2016"

  Related Standards

EN IEC 60118-0:2024

Medical devices Regulation ((EU) 2017/745)

Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids

EN IEC 60601-2-83:2020

Medical devices Regulation ((EU) 2017/745)

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light the...

EN ISO 13485:2016/AC:2018

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 14160:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues...

EN ISO 14971:2019

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 14971:2019/A11:2021

Medical devices Regulation ((EU) 2017/745)

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

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0