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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Take the iwo route to manage medical device compliance. This standard is a full technical revision of the version. Overview Product Details What is this standard about?

The following amendments have been made: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard? Biological indicators for ethylene oxide sterilization processes Status: You may experience issues viewing this site in Internet Explorer 9, 10 or 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.


Click to learn more. 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. Accept and continue Learn more about the cookies we use and how to change your settings. Your basket is empty.

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Biological indicators Biological indicators for moist heat sterilization processes. We use cookies to iwo our website easier to use and to better understand your needs.

BS EN ISO 11138-2:2017

This document gives specific requirements for those biological indicators intended for use in 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. Biological indicators for ethylene oxide sterilization processes.

Sterilization of health care products.


The other parts of the standard are: Biological indicators for dry heat sterilization processes Part 5: You may find similar items within these categories by selecting from the choices below:. Learn more about the cookies we use and how 111138-2 change your settings.


Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Search all products by. 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

Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO General requirements Part 3: Biological indicators for moist heat sterilization processes Part 4: The following amendments have been made:. Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological 111382- and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.

Find Similar Items This product falls into the following categories. Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Requirements of population and resistance clause 9 revised, e.

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