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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Biological indicators for ethylene oxide sterilization processes Status: Biological indicators for moist heat sterilization processes Part 4: Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

Accept and continue Learn more about the cookies we use and how to change your settings. Click to learn more. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard 11138-22 You may find similar items within these categories by selecting from the choices below:. Take the smart route 11183-2 manage medical device compliance.

Biological indicators for dry heat sterilization processes Part 5: The other parts of the standard are: Advice on selection, use and interpretation of results when using biological indicators can be found in ISO This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. 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.

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The following amendments have been made:.

ANSI/AAMI/ISO (PDF)

Please download Chrome or Firefox or view our browser tips. General requirements Part 3: Search all products by. 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. This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

Overview Product Details What is this standard about? Biological indicators for ethylene oxide sterilization processes.

This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes. The faster, easier way to work with standards.

Association for the Advancement of Medical Instrumentation

This standard is a full technical revision of the version. Learn more about the cookies we use and how to change your settings. Find Similar Items This product falls into the following categories. Sterilization of health care products.

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Requirements of population and resistance clause 111138-2 revised, e.

BS EN ISO 11138-2:2017

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 care products and biological indicators. Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Your basket is empty.

The following amendments have been made: Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers. We use cookies to make our website easier to use and to better understand your needs. You ios experience issues viewing this site in Internet Explorer 9, 10 or