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CSN EN ISO 11138-1
Sterilization of health care products - Biological indicators - Part 1: General requirements
|Number of Standard:||CSN EN ISO 11138-1|
EN ISO 11138-1
EN ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements - ISO 11138-1:2017 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. ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies. NOTE National or regional regulations can apply. ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.
This product includes:
CSN EN 867-5
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
CSN EN ISO 11140-4
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dicktype test for detection of steam penetration (ISO 11140-4:2007)
CSN EN ISO 11138-4
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
CSN EN ISO 11138-5
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ILNAS EN 285
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Sterilization - Steam sterilizers - Large sterilizers
CSN EN ISO 15883-4 ed. 3
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes