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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Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Learn more about the isp we use and how to change your settings. The other parts of the standard are: Part 1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators, including inoculated carriers and isl intended for use in validation and monitoring of sterilization processes.


Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers. This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators.

BS EN ISO 11138-2:2017

This standard is a full technical revision of the version. Take the smart route to manage medical device compliance. The following amendments have been made:. Search all products by. Biological indicators for ethylene oxide sterilization processes Status: This standard covers general requirements, test organism, suspension, carrier and io packaging, inoculated carriers and biological indicators, and population and resistance.

Association for the Advancement of Medical Instrumentation

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General requirements Part 3: Sterilization of health care products. Biological indicators Biological indicators for moist heat sterilization processes. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

The following amendments have been made: 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 sterilization see ISO and ISO Biological indicators for moist heat sterilization processes Part 4: Your basket is empty. Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?


Overview Product Details What is this standard about? The intent is not to promote the use of biological isso where such use is not advised, but rather to is common requirements for the production of those biological indicators that are known to be in use today.

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

Requirements of population and resistance clause 9 revised, e. You may experience issues viewing this site in Internet Explorer 9, 10 or