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).

Author: Vudorg Zulkigor
Country: Armenia
Language: English (Spanish)
Genre: Automotive
Published (Last): 21 September 2014
Pages: 451
PDF File Size: 20.60 Mb
ePub File Size: 16.15 Mb
ISBN: 261-9-85253-788-5
Downloads: 39488
Price: Free* [*Free Regsitration Required]
Uploader: Kesida

This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators.

Association for the Advancement of Medical Instrumentation

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 iiso use today.

This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

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.


This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes. Standards exist providing requirements for the validation and control of ethylene oxide sterilization see ISO and ISO Advice on selection, use and interpretation of results when using biological indicators can be found in ISO This standard is a full technical revision of the version. The following amendments 11138- been made:.


Learn more about the cookies we use and how to change your settings. Search all products by. Find Similar Items This product falls into the following categories. You may find similar items within these categories by selecting from the choices below:. Biological indicators for ethylene oxide sterilization processes Status: Click to learn more. Overview Product Details What is this standard about?

The other parts of the standard lso General requirements Part 3: Biological indicators for moist heat sterilization processes Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard 11138-2 Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?


The following amendments have been made: Requirements of population and resistance clause 9 revised, e. Your basket is empty. Take the smart route to manage medical device compliance.

The faster, easier way to work with standards. Biological indicators Biological indicators for moist heat sterilization processes. You may experience issues viewing this site in Internet Explorer 9, 10 or isi Please download Chrome or Firefox or view our browser tips. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

We use cookies to make our website easier to use and to better understand your needs. Accept and continue Learn more about the cookies we use and how to change your settings. Sterilization of health care products. Biological indicators for ethylene oxide sterilization processes.

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