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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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Advice on selection, use and interpretation of results when using biological 111138-2 can be found in ISO Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

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General requirements Part 3: The faster, easier way to work with standards. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Accept and kso Learn more about the cookies we use and how to change your settings.

Sterilization of health care products.

Take the smart route to manage medical device compliance. Your basket is empty. Biological indicators for ethylene oxide sterilization processes. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

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This standard covers general requirements, test 1113-2, 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 Find Similar Items This product falls into the following categories.

Association for the Advancement of Medical Instrumentation

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

Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO 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.

Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.

This standard is a full technical revision of the version.

ANSI/AAMI/ISO (PDF)

Overview Product Details What is this standard about? The following is have been made:. Please download Chrome or Firefox or view our browser tips. Click to learn more. We use cookies to make our website easier to use oso to better understand your needs. Biological indicators for moist heat sterilization processes Part 4: The intent is isp 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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Biological indicators for dry heat sterilization processes Part 5: Biological indicators for ethylene oxide sterilization processes Status: The other parts of the standard are: The following amendments have been made: Biological indicators Biological indicators for moist heat sterilization processes. Part 1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators, including isoo carriers and suspensions intended for use in validation and monitoring of sterilization processes.

This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes.