Need help?

EN ISO 13485:2016/A11:2021 Standard

wave
Save  

  Keywords:

#eu #requirements #relationship #can #regulations

  Directive

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

  Last Official Journal reference

Wednesday 5th of July 2023

  Description:

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

  Purpose

EN ISO 13485:2016/A11:2021 modifies the European standard EN ISO 13485:2016.EN ISO 13485 specifies requirements of a quality management system for medical devices. The main text and the consolidated version which consists of main text and the amendment can be found from the standard’s history. 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

Friday 7th of January 2022

  Amendment

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

  Related Standards

EN ISO 11737-1:2018/A1:2021

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

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

EN ISO 13485:2016

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

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

EN ISO 13408-6:2021

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

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

EN ISO 11737-2:2020

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

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

EN ISO 13485:2016/AC:2018

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

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

EN ISO 11737-1:2018

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

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

  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