ISO 11138-1 PDF

Summary: Specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators. BS EN ISO specifies general requirements for production, labelling, test methods and performance characteristics of biological. Published in March , the ISO documents have undergone an update. ISO Sterilization of healthcare products – Biological indicators.

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Find Similar Items This product falls into the following categories. National or regional regulations can apply. You may experience issues viewing this site in Internet Explorer 9, 10 or We use cookies to make our website easier to use and to better understand your needs.

Please download Chrome or Firefox or view our browser tips. This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators.

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ANSI/AAMI/ISO (PDF)

Your basket is empty. Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

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It specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO Learn more about the cookies we use and how to change your settings.

Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

BS EN ISO 11138-1:2017

Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Biological indicators for ethylene oxide sterilization processes Part 3: This document, however, can contain elements relevant to such microbiological test systems.

Accept and continue Learn more about the cookies we use and how to change your settings. It also specifies basic and common requirements that are applicable to all parts of ISO This standard is a full technical revision of the version, which makes the following amendments:.

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ISO 11138-1, Part 2

Click to learn more. This standard is a full technical revision of the version, which makes the following amendments: Biological indicators for isi heat sterilization processes Part 4: This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e. Biological indicators for dry heat sterilization processes Part 5: Overview Product Details What is this standard about? 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.

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