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

This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance. This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes. Search all products by. Standards 111338-2 providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Find Similar Items This product falls into the following categories.

You may find similar items within these categories by selecting from the choices below:. 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. You may experience issues viewing this site in Internet Explorer 9, 10 or Sterilization of health care products.

This standard is a full technical revision of the version. Biological indicators for moist heat sterilization processes Part 4: Please download Chrome or Firefox or view our browser tips. The other parts of the standard are: 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 isk to be in use today.

Learn more about the cookies we use and how to change your settings. Requirements of population and resistance clause 9 revised, e.


The faster, easier way to work with standards. The following amendments have been made:. 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 have been made: Biological indicators for ethylene oxide sterilization processes.

Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

General requirements Part 3: 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.


Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Biological indicators for dry heat sterilization processes Part 5: Biological indicators for ethylene oxide sterilization processes Status: Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

Take the smart route to manage medical device compliance.

Association for the Advancement of Medical Instrumentation

Accept 1118-2 continue Learn more about the cookies we use and how to change your settings. 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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