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Normas DIN – AENOR
DIN EN ISO 11135:2011-09

DIN EN ISO 11135:2011-09

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2011); German version prEN ISO 11135:2011 / Note: Date of issue 2011-09-26

Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux (ISO 11135:2011); Version allemande prEN ISO 11135:2011 / Attention: Date de parution 2011-09-26

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 11135:2011); Deutsche Fassung prEN ISO 11135:2011 / Achtung: Erscheinungsdatum 2011-09-26

Fecha Anulación:
2012-09 /Withdrawn
Equivalencias internacionales:

ISO/DIS 11135 (2011-09)

prEN ISO 11135 (2011-09)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11135:2012-09

Resumen:
This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications. This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
Keywords:
Acceptance (approval), Acceptance specification, Checks, Commissioning, Definitions, Ethylene oxide, Evaluations, Examination (quality assurance), Germicides, Hygiene, Inspection, Instructions, Maintenance, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Microbiological analysis, Operation, Operators (personnel), Personnel, Public health, Public health protection, Qualifications, Quality management, Routine tests, Safety, Safety engineering, Safety requirements, Specification (approval), Sterilization (birth control), Sterilization (hygiene), Sterilizers, Storage, Surveillance (approval), Testing, Validation
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