Need help?

EN ISO 11137-1:2015/A2:2019 Standard

wave
Save  

  Keywords:

#devices #medical #process #sterilization #control

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 2026

  Description:

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

  Purpose

Amendment for EN ISO 11137-1:2015

  Publication

Monday 19th of July 2021

  Amendment

This standard is an amendment for "EN ISO 11137-1:2015"

  Related Standards

EN ISO 13485:2016

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 11607-2:2020

Medical devices Regulation ((EU) 2017/745)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN ISO 10993-23:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

EN ISO 10993-12:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

EN ISO 10993-9:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

EN 285:2015+A1:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization - Steam sterilizers - Large sterilizers

  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