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Normas DIN – AENOR
DIN EN ISO 11135:2004-08

DIN EN ISO 11135:2004-08

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2004); German version prEN ISO 11135:2004

Stérilisation de produits de santé - Oxyde d'éthylène - Exigences de developpement, validation et contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux (ISO/DIS 11135:2004); Version allemande prEN ISO 11135:2004

Sterilisation von Produkten für die Gesundheitsfürsorge - Sterilisation mit Ethylenoxid - Anforderungen an die Entwicklung, Validierung und Routineüberwachung eines Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11135:2004); Deutsche Fassung prEN ISO 11135:2004

Fecha Anulación:
2016-01 /Withdrawn
Equivalencias internacionales:

ISO/DIS 11135 (2004-05)

prEN ISO 11135 (2004-05)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11135-1:2006-01

Resumen:
This Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
Keywords:
Acceptance (approval), Acceptance specification, Biological hazards, Calibration, Checks, Clearing, Commissioning, Compatibility, Conditioning, Cycle, Cyclic, Definitions, Developments, Equipment, Ethylene oxide, Evaluations, Examination (quality assurance), Germicides, Hygiene, Inspection, Instructions, Maintenance, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Methods, Microbiological, Microbiological analysis, Operation, Operators (personnel), Performance, Personnel, Physical, Public health, Public health protection, Qualifications, Quality management, Routine tests, Rules of procedure, Safety, Safety engineering, Safety requirements, Specification (approval), Sterilization (birth control), Sterilization (hygiene), Sterilizers, Storage, Surveillance (approval), Testing, Validation, Ventilation
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