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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Search all products by. Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, 111338-1 analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

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

This standard is a full technical revision of the version, which makes the following amendments: National or regional regulations can apply. 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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This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Take the smart route to manage medical device compliance. Worldwide Standards We can source any standard from anywhere in the world. We use cookies to make our website easier to use and to better understand your needs.

This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e. Learn more about the cookies we use and how to change your settings. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO Find Similar Items This product falls into the following categories.

ANSI/AAMI/ISO (PDF)

Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard? 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.

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The faster, easier way to work with standards. If no specific subsequent part is provided, this document applies. It also specifies basic and common requirements that are applicable to 1118-1 parts of ISO Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? You may experience issues viewing this site in Internet Explorer 9, 10 or The other parts of the standard are: Overview Product Details What is this standard about?

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

Click to learn more. Biological indicators for ethylene oxide sterilization processes Part 3: Please download Chrome or Firefox or view our browser tips. Biological indicators for moist heat sterilization processes Part 4: This document, however, can contain elements relevant to such microbiological test systems.