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Normas DIN – AENOR
DIN EN ISO 11135-1:2007-08

DIN EN ISO 11135-1:2007-08

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007

Stérilisation des produits de santé - Oxyde d'éthylène - Partie 1: Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux (ISO 11135-1:2007); Version allemande EN ISO 11135-1:2007

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 11135-1:2007); Deutsche Fassung EN ISO 11135-1:2007

Fecha Anulación:
2014-10 /Withdrawn
Equivalencias internacionales:

EN ISO 11135-1 (2007-05)

ISO 11135-1 (2007-05)

TS EN ISO 11135-1 (2010-01-26)

Relación con otras normas DIN:

Reemplaza a: DIN EN ISO 11135-1:2006-01

Reemplazada por: DIN EN ISO 11135:2014-10

Reemplaza a: DIN 58948-6:2003-04

Reemplaza a: DIN EN 550:1994-11

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, CE marking, 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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