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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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ANSI/AAMI/ISO (PDF)

Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO This website is best viewed with browser version of up to Microsoft Internet Explorer isoo or Firefox 3. Please download Chrome or Firefox or view our browser tips. Biological indicators for ethylene oxide sterilization processes Part 3: The other parts of the standard are: This standard is a full technical revision of the version, which makes the following amendments: You may experience issues viewing this site in Internet Explorer 9, 10 or 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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It also specifies basic and common requirements that are applicable to all parts of ISO Worldwide Standards We can source any standard ido anywhere in the world. Take the smart route to manage medical device compliance.

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Learn more about 11138- cookies we use and how to change your settings. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard? Overview Product Details What is this standard about? We use cookies to make our website easier to use and to better understand your needs.

Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing.

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

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

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Biological indicators for dry heat sterilization processes Part 5: You may find similar items within these categories by selecting from the choices 111381. This document, however, can contain elements relevant to such microbiological test systems.

ISO 11138-1, Part 2

Click to learn more. Find Similar Items This product falls into the following categories. This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators.

Biological indicators for moist heat sterilization processes Part 4: This standard is a full technical revision of the version, which makes the following amendments:.

If no specific subsequent part is provided, this document applies.