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EN ISO 11138-2:2009 Standard

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  Keywords:

#gas #test #sterilizing #indicators #biological

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  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 superseed 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 1422:1997+A1:2009

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Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

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