ISO 11138-2 PDF

ISO 11138-2 PDF

ISO Sterilization of health care products—Biological indicators— Part 2: Biological indicators for ethylene oxide sterilization processes. American. Summary: Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use. ISO Sterilization of health care products —. Biological indicators —. Part 2: Third edition. Reference number. ISO (E).

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General requirements Part 3: Biological indicators for dry heat sterilization processes Part 5: The faster, easier way to work with standards.


The intent is not to promote the use of biological indicators where such use is not advised, but rather to provide common requirements for the production of those biological indicators that are known to be in use today. Learn more about the cookies we use and how to change your settings. Organism-activity determination, Ethylene 111388-2, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.

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BS EN ISO 11138-2:2017

Biological indicators for ethylene oxide sterilization processes. Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Overview Product Details What is this standard about?

You may experience issues viewing this site in Internet Explorer 9, 10 or This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

This standard is a full technical revision of the version. This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators.

Association for the Advancement of Medical Instrumentation

Biological indicators Biological indicators for moist heat sterilization processes. Requirements of population and resistance clause 9 revised, e.

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The following amendments have been made: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? You may find similar items within these categories by selecting from the choices below:.


Biological indicators for moist heat sterilization processes Part 4: Biological indicators for ethylene oxide sterilization processes Status: The following amendments have been made:. The other parts of the standard are: Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Click to learn more. This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes.

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Your basket is empty. Find Similar Items This product falls into the following categories. Search all products by. Part 1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators, including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes.

Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?