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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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ANSI/AAMI/ISO (PDF)

We use cookies to make our website easier to use and to better understand your needs. This document, however, can contain elements relevant to such microbiological test systems. It specifies general requirements for production, labelling, test 1138-1 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.

National or regional regulations can apply. Biological isi for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Click to learn more. Biological indicators for moist heat sterilization processes Part 4: Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

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Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO Biological indicators for dry heat sterilization processes Part 5: Biological indicators for ethylene oxide sterilization processes Part 3: This standard is a full technical revision of the version, 1118-1 makes the following amendments:. This document does not sio to microbiological test systems for processes that rely on physical removal of microorganisms, e.

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Association for the Advancement of Medical Instrumentation

Overview Product Details What is this standard about? The other parts of the standard are: If no specific subsequent part is provided, this document applies. You may experience issues viewing this site in Internet Explorer 9, 10 or This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox ixo. Accept and continue Learn more about the cookies we use and how to change your isp. Find Similar Items This product falls into the following categories.

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ISO 11138-1, Part 2

This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators. Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis 11318-1 testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

This standard is a full technical revision of the version, which makes the following amendments: You may find similar items within these categories by selecting from the choices below:. Search all products by. It also specifies basic and common requirements that are applicable to all parts of ISO Learn more about the cookies we use and how to change your settings.