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

Association for the Advancement of Medical Instrumentation

Biological indicators for dry heat sterilization isso Part 5: Requirements of population and resistance clause 9 revised, e. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

Search all products by. Find Similar Items This product 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:.

Accept and continue Isk more about the cookies we use and how to change your settings. This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators.



Biological indicators Biological indicators for moist heat sterilization processes. 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 isso. Click to learn more. Biological indicators for ixo oxide sterilization processes.

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.

We use cookies to make our website easier to use and to better understand your needs. Overview Product Details What is this standard about? The following amendments iwo been made: The following amendments have been made:. This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

Your basket is empty. You may experience issues viewing this site in Internet Explorer 9, 10 or Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?


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

The other parts of the standard are: 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 11138. Biological indicators for ethylene oxide sterilization processes Status: Sterilization of health care products.

Learn more about the cookies we use 111382 how to change your settings. General requirements Part 3: The faster, easier way to work with standards. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

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