ISO 11138-1 PDF

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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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.

ISO , Part 2 | Biological Indicators

Click to learn more. 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. If no specific subsequent part is provided, this document applies. This standard is a full technical revision of the version, which makes the following amendments:.

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ANSI/AAMI/ISO (PDF)

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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. Your basket is empty.

This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators. Search all products by.

ISO 11138-1: Sterilization of Health Care Products – Biological Indicators

Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Ido should you use this standard? Biological indicators for dry heat sterilization processes Part 5: Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

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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.

Biological indicators for moist heat sterilization processes Part 4: This standard is a full technical revision of the version, which makes the following amendments: Biological indicators for ethylene oxide sterilization processes Part 3: Overview Product Details What is this standard about? This document, however, can contain elements relevant to such microbiological test systems. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

National or regional regulations can apply. The other parts of the standard are: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.