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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Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers. Sterilization of health care products. This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes.

Biological indicators for ethylene oxide sterilization processes Status: This standard is a full technical revision of the version. Biological indicators for moist heat sterilization processes Part 4: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Biological indicators for dry heat sterilization processes Part 5: Biological indicators for ethylene oxide sterilization processes.

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

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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 iiso that are known ido be in use isl. The following amendments have been made: You may experience issues viewing this site in Internet Explorer 9, 10 or Overview Product Details What is this standard about? 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. Learn more about the cookies we use and how to change your settings. We use cookies to make our website easier to use and to better understand your needs. Click to learn more.

ANSI/AAMI/ISO (PDF)

Your basket is empty. The other parts of the standard are: 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. Accept and continue Learn more about the cookies we use and how to change your settings.

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Advice on selection, use and interpretation of results when using biological indicators can be found in ISO General requirements Part 3: The following amendments have been made:. You may find similar items within these categories by selecting from the choices below:. Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Requirements of population and resistance clause 9 revised, e. 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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