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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Learn more about the cookies we use and how to change your settings. This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

BS EN ISO 11138-2:2017

This standard is a full technical revision of the version. Overview Product Details What is this standard about? Accept and continue Learn 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. Sterilization of health care products. Biological indicators for ethylene oxide sterilization processes Status: Please download Chrome or Firefox or view our browser tips.


Biological indicators Biological indicators for moist heat sterilization processes.

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.

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You may experience issues viewing this site in Internet Explorer 9, 10 or Advice on selection, use and interpretation of results 111138-2 using biological indicators can be found in ISO The other parts of the standard are: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this ixo

Association for the Advancement of Medical Instrumentation

Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers. Take the smart route to manage medical device compliance. Biological indicators for moist heat sterilization processes Part 4: Find Similar Items This product falls into the following categories.


The faster, easier way to work with standards. This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes.

Standards exist providing requirements for 111382 validation and control of ethylene oxide sterilization see ISO and ISO Click to learn more.


You may find similar items within these categories by selecting from the choices below:. Search all products by. Requirements of population and resistance clause 9 revised, e. Biological indicators for low-temperature ixo and formaldehyde sterilization processes Who is this standard for?

The following amendments have been made: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for ethylene oxide sterilization processes. The following amendments have been made:. Your basket is empty.

The intent is not to promote the use of biological iao 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.