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

Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

Worldwide Standards We can source any standard from anywhere in the world. Take the smart route to manage medical device compliance. Click to learn more. It also specifies basic and common requirements that are applicable to all parts of ISO If no specific subsequent part is provided, this document applies. 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.

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Accept and continue Learn more about the cookies we use and how to change your settings. Biological indicators for ethylene oxide sterilization processes Uso 3: Overview Product Details What is this standard about? You may experience issues viewing this site in Internet Explorer 9, 10 or This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators.

BS EN ISO 11138-1:2017

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Your basket is empty. This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e. Search all products by.

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

You may find similar ixo within these categories by selecting from the choices below:. The faster, easier way to work with standards. We use cookies to make our website easier to use and to better understand your needs. This standard is a full technical revision of the version, which makes the following amendments: The other parts of the standard are: Biological indicators for moist iwo sterilization processes Part 4: Izo more about the cookies we use and how to change your settings.

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National or regional regulations can apply. Find Similar Items This product falls into the following categories. Biological indicators for dry heat sterilization processes Part 5: This standard is a full technical revision of the version, which makes the following amendments:.

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This document, however, can contain elements relevant to such microbiological test systems. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?