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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ISO 11138-1, Part 2

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. It also specifies basic and common requirements that are applicable to all parts of ISO Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO If no specific subsequent isi is provided, this document applies.

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This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e. This document, however, can contain elements relevant to such microbiological test systems. This standard is a full technical revision of the version, which makes the following amendments:.

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ISO , Part 2 | Biological Indicators

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Overview Product Details What is this standard about? The other parts of the standard are: Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for moist heat sterilization processes Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological 11138- 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?

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National or regional regulations can 1113-1. This standard is a full technical revision of the version, which makes the following amendments: Your basket is empty. Take the smart route to manage medical device compliance. The faster, easier way to work with standards. You may experience issues viewing this site in Internet Explorer 9, 10 or Please download Chrome or Firefox or view our browser tips.

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

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