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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 25th of March 2020

  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 superseed the "EN 550:1994"

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

  Related Standards

EN ISO 11138-2:2009

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EN ISO 10993-17:2009

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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 11607-1:2009

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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 11140-1:2009

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

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

EN ISO 11138-3:2009

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

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process...

EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)

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

Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

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