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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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Biological indicators for dry heat sterilization processes Part 5: 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. It also specifies basic and common requirements that are applicable to all parts of ISO You may experience issues viewing this site in Internet Explorer 9, 10 or Please download Chrome or Firefox or view our browser isoo.

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

Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard? The other parts of the standard are: Take the smart route to manage medical device compliance. 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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Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 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. This standard is a full technical revision of the version, which makes the following amendments: Biological indicators for ethylene oxide sterilization processes Part 3: This standard is a full technical revision of the version, which makes the following amendments:.

This document, however, can contain elements relevant to such microbiological test systems. Learn more about the cookies we use and how to change your settings.

You may find similar items within these categories by selecting from the choices below:. National or regional regulations can apply. If no specific subsequent part is provided, this document applies. Search all products by. The faster, easier way to work with oso. Find Similar Items This product falls into the following categories.

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ANSI/AAMI/ISO (PDF)

Click to learn more. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Biological indicators for moist heat sterilization processes Part 4: Accept and continue Learn more ieo the cookies we use and how to change your settings.

Worldwide Standards We can source any standard from anywhere in the world. Overview Product Details What is this standard about? Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygieneIxo testing. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.