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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This document does not apply to microbiological 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.

The other parts of the standard are: The faster, easier way to work with standards. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO Worldwide Standards We can source any standard from anywhere in the world. It also specifies basic and common requirements that are applicable to all parts of ISO This document, however, can contain elements relevant to such microbiological test systems.

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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.

ISO 11138-1, Part 2

Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Accept and continue Learn more about the cookies we use and how to change your settings.

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Your basket is empty. Biological indicators for dry heat sterilization processes Part 5: Learn more about the cookies we use and how to change your settings. If no specific subsequent part is provided, this document applies. 1138-1

Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard? Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

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Please download Chrome or Firefox or view our browser tips. This standard is a full technical revision of the version, which makes the following amendments: Overview Product Details What is this standard about?

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ISO Sterilization of Health Care Products – Biological Indicators | Biological Indicators

Biological indicators for ethylene oxide sterilization processes Part 3: This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators. Take the smart route to manage medical device compliance.

You may experience issues viewing this site in Internet Explorer 9, 10 or Biological indicators for moist heat iwo processes Part 4: Click to learn more. This standard is a full technical revision of the version, which makes the following amendments:. Search all products by.