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ISO 11138-7:2019

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results

Pages: 72
Publication date: 2019-03-01
Price: Contact

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This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.It is not applicable to liquid immersion sterilization processes.
Document identifier
ISO 11138-7:2019
Title
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
ISO Category
TC 198: Sterilization of health care products
Publication date
2019-03-01
Status
Effective
International Relationship
BS EN ISO 11138-7:2019
Cross references
Latest version
ISO 11138-7:2019
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
Document identifier ISO 11138-7:2019
Publication date 2019-03-01
Classification 11.080.01. Sterilization and disinfection in general
Status Effective
*
History of version
ISO 11138-7:2019 * ISO 14161:2009 * ISO 14161:2000
Keywords
Classification
11.080.01. Sterilization and disinfection in general
Pages
72
Price Contact

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