ISO 11138-1 PDF


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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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National or regional regulations can apply. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. This standard is a full technical revision of the version, which makes the following amendments: Take the smart route 111388-1 manage medical device 111388-1. You may find similar items within these categories by selecting from the choices below:. Your basket is empty. The other parts of the standard are: Please download Chrome or Firefox or view our browser tips.

The faster, easier way to work with standards. You may experience issues viewing this site in Internet Explorer 11138–1, 10 or 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)

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

Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

Overview Product Details What is this standard about? This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other 111338-1 responsible for sterilization Why should you use this standard?

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Association for the Advancement of Medical Instrumentation

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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:.

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.

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

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: This document, however, can contain elements relevant to such microbiological test systems. Worldwide Standards We can source any standard from anywhere in the world.