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 10993-18:2020/A1:2023

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

EN ISO 10993-4:2017/A1:2025

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

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 IEC 60601-2-83:2020/A11:2021

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 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