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BSI BS EN ISO 11138-1:2017

Sterilization of health care products. Biological indicators -- General requirements
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BSI BS EN ISO 11138-1:2017

Sterilization of health care products. Biological indicators -- General requirements

PUBLISH DATE 2017
PAGES 52
BSI BS EN ISO 11138-1:2017

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.

SDO BSI: British Standards Institution
Document Number ISO 11138-1
Publication Date April 30, 2017
Language en - English
Page Count 52
Revision Level
Supercedes
Committee CH/198
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