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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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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-4:2009

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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN 45502-2-3:2010

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Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

EN 45502-2-1:2003

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Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat br...

EN ISO 14937:2009

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

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

EN ISO 13408-5:2011

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

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

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