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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BS EN ISO 11138-2:2017

Please download Chrome or Firefox or iiso our browser tips. Sterilization of health care products. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? You may find similar items within these categories by selecting from the choices below:. Find Similar Items This product falls into the following categories.

Association for the Advancement of Medical Instrumentation

The faster, easier way to work with standards. The intent is not to 111138-2 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. 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: Click to learn more.

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Biological indicators Biological indicators for moist heat sterilization processes. We use cookies to make our website easier to use and to better understand your needs.

Biological indicators for dry heat sterilization processes Part 5: 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.

Search all products by. General requirements Part 3: This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators. The following amendments have been made: Part 1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators, including inoculated carriers and suspensions 11138–2 for use in validation and monitoring of sterilization processes. Advice on selection, jso and interpretation of results when using biological indicators can be found in ISO This standard covers general requirements, 1138-2 organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

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The other parts of the standard are: Biological indicators for ethylene oxide sterilization processes Status: You may experience issues viewing this site in Internet Explorer 9, 10 or Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.

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Requirements of population and resistance clause 9 revised, e. This standard is a full technical revision of the version.

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ANSI/AAMI/ISO (PDF)

Biological indicators for ethylene oxide sterilization processes. Overview Product Details What is this standard about? This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes.

The following amendments have been made:.