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60.60 Standard published Apr 17, 2019
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
Published
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.
Legislation related to this standard
WITHDRAWN
EN ISO 14161:2009
PUBLISHED
EN ISO 11138-7:2019
60.60
Standard published
Apr 17, 2019