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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Find Similar Items This isk falls into the following categories. This standard is a full technical revision of the version. You may find similar items within these categories by selecting from the choices below:. This document gives specific requirements for those io 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.

Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Iwo basket is empty. Requirements of population and resistance clause 9 revised, e. Please download Chrome or Firefox or view our browser tips. We use cookies to make our website easier to use and to better understand your needs. Accept and continue Learn more about the cookies we use and how to change your settings.


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General requirements Part 3: Click to learn more. Biological indicators Biological indicators for moist heat sterilization processes. This is the second part of a five part standard the ISO series on the sterilization of health izo products and biological indicators.

BS EN ISO 11138-2:2017

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. The following amendments have been made:. Biological indicators for ethylene oxide sterilization processes Status: Biological indicators for moist heat sterilization processes Part 4: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

Overview Product Details What is this standard about? The following amendments have been made: Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO 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.


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. 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 Jso control professionals Other professionals responsible for sterilization Why should you use this standard? You may experience issues viewing this site in Internet Oso 9, 10 or Learn more about the cookies we use and how to change your settings. The other parts of the standard are: