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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Accept and continue Learn more about the cookies we use and how to change your settings. Please download Chrome or Firefox or view our browser tips. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

Association for the Advancement of Medical Instrumentation

This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators. The other parts of the standard are: You may experience issues viewing this site in Internet Explorer 9, 10 or Take the smart route to manage medical device compliance.

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Biological indicators for ethylene oxide sterilization processes Part 3: This standard is a full technical revision of the version, which makes the following amendments: Biological indicators for moist heat sterilization processes Part 4: Worldwide Standards We can source any standard from anywhere in the world.

Requirements for biological indicators for particular 111381 processes are provided in the relevant parts of ISO This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. We use cookies to make our website easier to use and to better understand your needs.

ANSI/AAMI/ISO (PDF)

Biological indicators for dry heat sterilization processes Part 5: Learn more about the cookies we use and how to change your settings. 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.

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Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Search all products by. Overview Product Details What is this standard about? This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.

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ISO , Part 2 | Biological Indicators

Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

Find Similar Items This product falls into the following categories. This standard is a full technical revision of the version, which makes the following amendments:. It also specifies basic and common requirements that are applicable to all parts of ISO The faster, easier way to work with standards.

ISO 11138-1, Part 2

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