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 standard is a full technical revision of the version. We use cookies to make our website easier to use and to better understand your needs. Sterilization of health care products. Is and continue Learn more about the cookies we use and how to change your settings. The following amendments have been made: Take the smart route to manage io device compliance. Requirements of population and resistance clause 9 revised, e. Biological indicators for dry heat sterilization processes Part 5: Biological indicators for ethylene oxide sterilization processes.

Biological indicators Biological indicators for moist heat sterilization processes.

Association for the Advancement of Medical Instrumentation

The faster, easier way to work with standards. Overview Product Details What is this standard about? 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 standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

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Your basket is empty. Biological indicators for ethylene oxide sterilization processes Status: This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes. Click to learn more. The following amendments have been made:.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological ios and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.

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ANSI/AAMI/ISO (PDF)

You may experience issues viewing this site in Internet Explorer 9, 10 or General requirements Part 3: Part 1 specifies production, labelling, test methods and io requirements for the manufacture of biological indicators, including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. Search all products by.

Advice on selection, use and interpretation of results when using biological indicators can be found in ISO 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 jso see ISO and ISO The other parts of the standard are: 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? Biological indicators for moist heat sterilization processes Part 4: Please download Chrome or Firefox or view our browser tips.

This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators. Learn more about the cookies we use and how to change your settings.