DIN EN ISO 14937:2010-03

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009

Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux (ISO 14937:2009); Version allemande EN ISO 14937:2009

Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an die Charakterisierung eines sterilisierenden Agens und an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 14937:2009); Deutsche Fassung EN ISO 14937:2009

Información:

Fecha:

2010-03 /Active

ICS:

11.080.01 - Sterilization and disinfection in general

Equivalencias internacionales:

EN ISO 14937 (2009-10)

ISO 14937 (2009-10)

TS EN ISO 14937 (2011-11-22)

Relación con otras normas DIN:

Reemplaza a: DIN EN ISO 14937:2008-01

Reemplaza a: DIN EN ISO 14937:2001-05

Resumen:

This Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation, and routine monitoring and control of a sterilization process for medical devices.Note Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.This Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.

Keywords:

Agents, CE marking, Characterisations, Definitions, Developments, Gamma-radiation, Health protection, Hygiene, Inspection, Ionizing radiation, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Methods, Processes, Qualifications, Quality assurance systems, Radiation, Specification, Specification (approval), Sterilization (birth control), Sterilization by irradiation, Sterilization (hygiene), Sterilizers, Sterilizing apparatus, Surveillance (approval), Use, Validation

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