Sterilizace výrobků pro zdravotní péči - Biologické indikátory - Část 7: Návod pro výběr, použití a interpretaci výsledků (Norma k přímému použití jako ČSN).
NORMA vydána dne 1.10.2019
Designation standards: ČSN EN ISO 11138-7
Classification mark: 855261
Catalog number: 507939
Publication date standards: 1.10.2019
The number of pages: 80
Approximate weight : 240 g (0.53 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN
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