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 moist heat sterilization processes Part 4: Sterilization of health care products. Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Biological indicators Biological indicators for moist heat sterilization processes. The intent is not to promote the use of biological isso 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 is a full technical revision of the version. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?


Requirements of population and resistance clause 9 revised, e. Biological indicators for ethylene oxide sterilization processes Status: We use cookies to make our website easier to use and to better understand your needs. This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators. This document gives specific requirements for those biological indicators intended ios use in ethylene oxide sterilization processes.

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Biological indicators for dry heat sterilization processes Part 5: Accept and continue Learn more about the cookies we use and how to change your settings.

Overview Product Details What is this standard about? Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Biological indicators for ethylene oxide sterilization processes. The other parts of the standard are: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. The following amendments have been made:.

BS EN ISO 11138-2:2017

This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.


Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.

You may experience issues viewing this site in Internet Explorer 9, 10 or General requirements Part 3: Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Take the smart route to manage medical device compliance.

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Association for the Advancement of Medical Instrumentation

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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. Find Similar Items This product falls into the following categories.