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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It also specifies basic and common requirements that are applicable to all parts of ISO Biological indicators for dry 11318-1 sterilization processes Part 5: Worldwide Standards We can source any standard from anywhere in the world. The faster, easier way to work with standards.
The other parts of the standard are: Biological indicators for ethylene oxide sterilization processes Part 3: National or regional regulations can apply. Overview Product Details What is this standard about? Take the smart route to manage medical device compliance.
This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e. Please download Chrome or Firefox or view our browser tips.
Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO You may find similar items within these categories by selecting from the choices below:. Search all products by.
This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Click to learn more. Learn more about the cookies we use and how to change your settings. Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for? Biological indicators for moist heat sterilization processes Part 4: If no specific subsequent part is provided, this document applies.
This standard is a full technical is of the version, which makes the following amendments:.
ISO 11138-1, Part 2
This document, however, can contain elements relevant to such microbiological test systems. Your basket is empty. Labelling processPackaging, Culture containers, Culture techniques, Microbiological analysis, Biological analysis and testing, Medical equipment, Sterilizers, Microorganisms, Bioassay, Sterilization hygienePerformance testing. You may experience issues viewing this site in Internet Explorer 9, 10 or This is the first part of a five part standard the ISO series on the sterilization of health care products and biological indicators.
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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