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ČSN EN ISO 11138-1 (847111)
Sterilization of health care products - Biological indicators - Part 1: General requirements
Translate name
STANDARD published on 1.10.2017
The information about the standard:
Designation standards: ČSN EN ISO 11138-1
Classification mark: 847111
Catalog number: 502943
Publication date standards: 1.10.2017
SKU: NS-796811
The number of pages: 56
Approximate weight : 168 g (0.37 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 11138-1 (847111):
This document 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.
This document 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.
This document 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
