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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Standards exist ieo requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Sterilization of health care products.

Take the smart route to manage medical device compliance. Click to learn more. Biological indicators Biological indicators for moist heat sterilization processes.

Association for the Advancement of Medical Instrumentation

This document gives specific requirements for those biological indicators 1138-2 for use in ethylene oxide sterilization processes. You may experience issues viewing this site in Internet Explorer 9, 10 or 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? Overview Product Details What is this standard about?


The following amendments have been made:. Requirements of population and resistance clause 9 revised, e. We use cookies to make our website easier to use and to better understand your needs. Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers. Biological indicators for ethylene oxide sterilization processes Status: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

BS EN ISO 11138-2:2017

Biological indicators for ethylene oxide sterilization processes. Your basket is empty. General requirements Part 3: The following amendments have been made: Find Similar Items This product falls into the following categories. This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance. 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 faster, easier 111338-2 to work with standards. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Learn more about the cookies we use and how to change your settings.


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.

Search all products by. This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators. The other parts of the standard are: Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Please download Chrome or Firefox or view our 111138-2 tips. This standard is a full technical revision of the version. Biological indicators for dry heat sterilization processes Part 5: You may find similar items within these categories by selecting from the choices below:.