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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Biological indicators for ethylene oxide sterilization processes Status: Find Similar Items This product falls into the following categories. Biological indicators Biological indicators for moist heat sterilization processes. The other parts of the standard are: This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

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BS EN ISO 11138-2:2017

The faster, easier way to work with standards. Overview Product Details What is this standard about? Organism-activity determination, Ethylene 11138- Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.


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This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes. Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO 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.

Requirements of population and resistance clause 9 revised, e. Learn more about the cookies we use and how to change your settings. Accept and continue Learn more about the cookies we use and how to change your settings. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

General requirements Part 3: Biological indicators for moist heat sterilization processes Part 4: Sterilization of health care products.


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Part 1 specifies production, labelling, test methods and performance requirements for the manufacture of 1138-2 indicators, including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. The following amendments have been made: Biological indicators for dry heat sterilization processes Part 5: You io find similar items within these categories by selecting from the choices below:.

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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?

Association for the Advancement of Medical Instrumentation

Biological indicators for ethylene oxide sterilization processes. This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators. Advice on selection, use and interpretation of results when using biological indicators can be found in ISO