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EN ISO 11135-1:2007 Standard

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  Keywords:

#devices #sterilization #health #care #products

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

  Purpose

This part of ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 550:1994"

Anyway is still possible use the "EN 550:1994" until May 31st, 2010

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