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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ISO , Part 2 | Biological Indicators

This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e. National or regional regulations can apply. Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

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Click to learn more. 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.

You may experience issues viewing this site in Internet Explorer 9, 10 or Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

Biological indicators for moist heat sterilization processes Part 4: Accept and continue Learn more about the cookies we use and how to change your settings.

This standard is a full technical revision of the version, which makes the following amendments: Your basket is empty.

Association for the Advancement of Medical Instrumentation

Find Similar Items This product falls into the following categories. This is the first part of a five part standard the ISO series on the sterilization of health care products uso biological indicators. Learn more about the cookies we use and how to change your settings. Biological indicators for ethylene oxide sterilization processes Part 3: Please download Chrome or Firefox or view our browser tips.

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Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Requirements for biological indicators for particular specified processes are provided in the relevant 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

If no specific subsequent part is provided, this document applies. This document, however, can contain elements relevant to such microbiological test systems.

The other parts of the standard are: We use cookies to make our website easier to use and to better understand your needs. Overview Product Details What is this standard about?