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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This document does not apply to microbiological test systems kso processes that rely on physical removal of microorganisms, e. 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.

Association for the Advancement of Medical Instrumentation

Overview Product Details What is this standard about? Biological indicators for dry heat sterilization processes Part 5: This document, however, can contain elements relevant to such microbiological test systems. Click to learn more. This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators. Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis isp testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygiene isk, Performance testing.

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Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

ANSI/AAMI/ISO (PDF)

This standard is a full technical revision of the version, which makes the following amendments: 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 ethylene oxide sterilization processes Part 3: Search all products by. Your basket is empty. Learn more about the cookies we use and how to change your settings. National or regional regulations can apply. Accept and continue Learn more about the cookies we use and how to change your settings.

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

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 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:.

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If no specific subsequent part is provided, this document applies. Biological indicators for moist heat sterilization processes Part 4: You may find similar items within these categories by selecting from the choices below:. You may experience issues viewing this site in Internet Explorer 9, 10 or Find Similar Items This product falls into the following izo. Worldwide Standards We can source any standard from anywhere in the world.

The faster, easier way to work with standards. The other parts of the standard are: Take the smart route to manage medical device compliance. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?