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EN ISO 11138-2:2009 Standard

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  Keywords:

#gas #test #sterilizing #indicators #biological

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

  Purpose

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 11138-2:2006"

Anyway is still possible use the "EN ISO 11138-2:2006" until March 21st, 2010

  Related Standards

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EN ISO 10993-12:2012

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

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

EN ISO 13408-5:2011

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Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

EN ISO 11737-2:2009

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

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

EN ISO 11737-1:2006/AC:2009

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

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

EN ISO 11737-1:2006

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

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

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