Need help?

EN ISO 13485:2016/AC:2018 Standard

wave
Save  

  Keywords:

#quality #purposes #regulatory #requirements #systems

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

Corrigendum for EN ISO 13485:2016

  Publication

Wednesday 25th of March 2020

  Correction

This standard is a correction for "EN ISO 13485:2016"

  Related Standards

EN IEC 60601-2-66:2020

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids a...

EN 1041:2008

Medical devices Directive (93/42/EEC)

Information supplied by the manufacturer of medical devices

EN ISO 15747:2019

Medical devices Directive (93/42/EEC)

Plastic containers for intravenous injections (ISO 15747:2018)

EN ISO 15883-4:2018

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endo...

EN ISO 17664:2017

Medical devices Directive (93/42/EEC)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical d...

EN ISO 21987:2017

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017)

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 13485:2016/AC:2018 STANDARD

  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