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Norm
ÖNORM EN ISO 11138-7
Issue date: 2019 10 15
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation an...
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Publisher:
Austrian Standards International
Format:
Digital | 77 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 11138-7
2019 10 15
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, ...
Norm
↖
ÖNORM EN ISO 14161
2010 02 15
Sterilization of health care products - Biological indicators - Guidance for the selection, use and ...
Norm
ÖNORM EN ISO 14161
2001 05 01
Sterilization of health care products - Biological indicators - Guidance for the selection, use and ...
Norm
Norm
ISO 11138-7:2019
Issue date :
2019 03 12
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results