ISO 11138-1 PDF

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 low-temperature steam and formaldehyde sterilization processes Who is this standard for? 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 Biological indicators for ethylene oxide sterilization processes Part 3: Please download Chrome or Firefox or view our browser tips.

Take the smart route to manage medical device compliance. It also specifies basic and common requirements that are applicable to all parts of ISO 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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ANSI/AAMI/ISO (PDF)

Click to learn more. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO The faster, easier way to work with standards.

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

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BS EN ISO 11138-1:2017

If no specific subsequent part is provided, this document applies. 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 dry heat sterilization processes Part 5: You may find similar items within these categories by selecting from the choices below:. Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing. Accept and continue Learn more about the cookies we use and how to change your settings.

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ISO , Part 2 | Biological Indicators

Search all products by. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Uso should you use this standard?

This standard is a full technical revision of the version, which makes the following amendments:. Biological indicators for moist heat sterilization processes Part 4: Learn more about the cookies io use and how to change your settings. Worldwide Standards We can source any standard from anywhere in the world. This document, however, can contain elements relevant to such microbiological test systems.

The other parts of the standard are: