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, however, can contain elements relevant to such microbiological test systems. Find Similar Items This product falls into the following categories.

Click to learn more. This standard is a full technical revision of the version, which makes the following amendments:.

BS EN ISO 11138-1:2017

Take the smart route to manage medical device compliance. The faster, easier way to work with standards. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

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It also specifies basic and common requirements that are applicable to all parts of ISO This standard is a full technical revision of the version, 111138-1 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.

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

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

Learn more about the cookies we use and how to change your settings. This document does not apply to microbiological test systems for processes that rely on physical removal isp microorganisms, e.

Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Accept and continue Learn more about the cookies we use and how to change your settings. Biological indicators for dry heat sterilization processes Part 5: Your basket is empty. You may find similar items within these categories by selecting from the choices below:.

ISO , Part 2 | Biological Indicators

Biological indicators for ethylene oxide 111388-1 processes Part 3: Worldwide Standards We ixo source any standard from anywhere in the world.

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The other parts of the standard are: We use cookies to make our website easier to use and to better understand your needs. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO Biological indicators for moist heat sterilization processes Part 4: 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.

Association for the Advancement of Medical Instrumentation

You may experience issues 11138- this site in Internet Explorer 9, 10 or Please download Chrome or Firefox or view our browser tips. National or regional regulations can apply. Overview Product Details What is this standard about?