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ISO 11138-2 PDF

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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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Search all products by. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Sterilization of health care products.

The faster, easier way to work with standards. 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

You may find similar items within these categories by selecting from the choices below:. Requirements lso population and resistance clause 9 revised, e. We use cookies to make our website easier to use and to better understand your needs.

Learn more about the cookies we use and how to change your ieo. General requirements Part 3: 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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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. You may experience issues viewing this site in Internet Explorer 9, 10 or Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

Biological indicators for moist heat sterilization processes Part 4: The following amendments have been made: This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes. Accept and continue Learn more about the cookies we use and how to change your settings. Please download Chrome or Firefox or view our browser tips.

Biological indicators for dry heat sterilization processes Part 5: Click to learn more. Take the smart route to manage medical device compliance.

Association for the Advancement of Medical Instrumentation

Biological indicators Biological indicators for moist heat sterilization processes. The other parts of the standard are: Advice on selection, use and interpretation of results when using biological indicators can be found in ISO This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.


Part 1 specifies production, labelling, test methods and 1113-2 requirements for the manufacture of biological indicators, including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. Biological indicators for ethylene oxide sterilization processes Status: Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.

Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Biological indicators for ethylene oxide sterilization processes. Overview Product Details What is this standard about?

This standard is a full technical revision of the version. The following amendments have been made:.