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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Sterilization of health care products. This document gives specific requirements for those biological indicators intended for use in 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. Learn more about the cookies we use and how to change your settings.

Requirements 111338-2 population and resistance clause 9 revised, e. We use cookies to make our website easier to use and to better understand your needs.

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You may experience issues viewing this site in Internet Explorer 9, 10 or The other parts of the standard are: Biological indicators for dry heat sterilization processes Part 5: General requirements Part 3: Biological indicators for ethylene oxide sterilization processes Status: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

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

Your basket is empty. Biological indicators Biological indicators for moist heat sterilization processes. You may find similar items within these categories by selecting from the choices below:.

BS EN ISO 11138-2:2017

Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Biological indicators for moist heat sterilization processes Part 4: Accept and continue Learn more about the cookies we use and how to change your settings. 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.

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ANSI/AAMI/ISO (PDF)

Biological indicators for ethylene oxide sterilization processes. This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance. Click to learn more.

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Take the smart route to manage medical device compliance. Overview Product Details What is this standard about?

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 version. 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.

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