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Normas DIN – AENOR
DIN EN ISO 15882:2008-12

DIN EN ISO 15882:2008-12

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008); German version EN ISO 15882:2008

Stérilisation des produits de santé - Indicateurs chimiques - Directives pour la sélection, l'utilisation et l'interprétation des résultats (ISO 15882:2008); Version allemande EN ISO 15882:2008

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO 15882:2008); Deutsche Fassung EN ISO 15882:2008

Fecha:
2018-12 /Active
Equivalencias internacionales:

EN ISO 15882 (2008-09)

ISO 15882 (2008-09)

TS EN ISO 15882 (2017-03-16)

Relación con otras normas DIN:
Resumen:
This document provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation, and routine monitoring and control of sterilization processes. This document applies to chemical indicators that show exposure to sterilization processes by means of physical and/or chemical changes of substnaces, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. These chemical indicators are not dependet for their action on the presence or absence of a living organism. This document does not consider indicators for use in those processes that rely on physical removal of microorganisms, e. g., filtration. This document is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).
Keywords:
Chemical indicators, Classification, Definitions, Developments, Guide books, Indicators, Interpretations, Marking, Medical devices, Medical equipment, Medical products, Medical sciences, Public health, Quality assurance, Results, Selection, Specification (approval), Sterilization (birth control), Sterilization (hygiene), Sterilizing apparatus, Surveillance (approval), Tracer methods, Use, Validation
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