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ISO 11138-1 PDF

February 23, 2019

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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Biological indicators for dry heat sterilization processes Part 5: Accept and continue Learn more about the cookies we use and how to change your settings. This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators. This document, however, can contain elements relevant to such microbiological test systems.

ISO , Part 2 | Biological Indicators

This standard is a full technical revision of the version, which makes the following amendments: Biological indicators for ethylene oxide iiso processes Part 3: Biological indicators for low-temperature steam and formaldehyde sio processes Who is this standard for? Overview Product Details What is this standard about? Learn more about the cookies we use and how to change your settings. If no specific subsequent part is provided, this document applies.

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Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard? It also specifies basic and common requirements that are applicable to all parts of ISO Please download Chrome or Firefox or view our browser tips.

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Association for the Advancement of Medical Instrumentation

You may experience issues viewing this site in Internet Explorer 9, 10 or National or regional regulations 1113-81 apply. This standard is a full technical revision of the version, which makes the following amendments:. Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

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ANSI/AAMI/ISO (PDF)

The faster, easier way to work with standards. Click to learn more. This document does not apply to 1118-1 test systems for processes that rely on physical removal of microorganisms, e. We use cookies to make our website easier to use and to better understand your needs. Worldwide Standards We can source any standard from anywhere in the world.

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 111138-1 sterilization processes.

The other parts of the standard are: Biological indicators for moist heat sterilization processes Part 4: