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

Thursday 11th of June 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 285:2015+A1:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization - Steam sterilizers - Large sterilizers

EN ISO 14630:2024

Medical devices Regulation ((EU) 2017/745)

Non-active surgical implants - General requirements (ISO 14630:2024)

EN 1865-2:2024

Medical devices Regulation ((EU) 2017/745)

Patient handling equipment used in ambulances - Part 2: Power assisted stretcher

EN 1865-6:2024

Medical devices Regulation ((EU) 2017/745)

Patient handling equipment used in ambulances - Part 6: Powered chairs'

EN 13795-1:2025

Medical devices Regulation ((EU) 2017/745)

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

EN 13795-2:2025

Medical devices Regulation ((EU) 2017/745)

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

  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