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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This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators. The intent is not to uso 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. This standard covers 111338-2 requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

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.


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 Advice on selection, use and interpretation of results when using biological indicators can be found in ISO This standard is a full technical revision of the 1113-2.

The following amendments have been made:.

BS EN ISO 11138-2:2017

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Overview Product Details What is this standard about? The other parts of the standard are: General requirements Part 3: Biological indicators for moist heat sterilization processes Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?


The following amendments have been made: Requirements of population and resistance clause 9 revised, e.

Association for the Advancement of Medical Instrumentation

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Sterilization of health care products. Biological indicators for ethylene oxide sterilization processes. Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.