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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Find Similar Items This product falls into the following categories. We use cookies to make our website easier to use and to better understand your needs. The faster, easier way to work with standards. This standard is a full technical revision of the version, which makes the following amendments: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

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This document does not apply to microbiological test systems for processes that 11183-1 on physical removal of microorganisms, e. Worldwide Standards We can source any standard from anywhere in the world. This standard is a full technical revision of the version, which makes the following amendments:.

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

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

Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard? Search all products by. National or regional regulations can apply. If no specific subsequent part is provided, this document applies. It also specifies iwo and isi requirements that are applicable to all parts of ISO Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

Overview Product Details What is this standard about? You may find similar items within these categories by selecting from the choices below:.

Click to learn more. 1118-1 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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Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

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

Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO Biological indicators for dry heat sterilization processes Part 5: The other parts of the standard are: Biological indicators for moist heat sterilization processes Part 4: Learn more about the cookies we use and how to change your settings.

Take the smart route to manage medical device compliance. This document, however, can contain elements relevant to such microbiological test systems. You may experience issues viewing this site in Internet Explorer 9, 10 or