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Normas DIN – AENOR
DIN EN ISO 17665-1:2006-11

DIN EN ISO 17665-1:2006-11

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006

Stérilisation des produits de santé - Chaleur humide - Partie 1: Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation des dispostifs médicaux (ISO 17665-1:2006); Version allemande EN ISO 17665-1:2006

Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 17665-1:2006); Deutsche Fassung EN ISO 17665-1:2006

2016-11 /Active
Equivalencias internacionales:

EN ISO 17665-1 (2006-08)

ISO 17665-1 (2006-08)

TS EN ISO 17665-1 (2014-11-11)

Relación con otras normas DIN:

Reemplaza a: DIN EN ISO 17665:2004-10

Reemplaza a: DIN 58946-6:2002-04

Reemplaza a: DIN EN 554:1994-11

This Standard specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by this Standard include but are not limited to: a) saturated steam venting systems; b) saturated steam active air removal systems; c) air steam mixtures; d) water spray; e) water immersion.
Acceptance (approval), Bearings, Biological hazards, CE marking, Checks, Clearing, Commissioning, Compatibility, Control, Definitions, Equipment, Evaluations, Examination (quality assurance), Germicides, Guide books, Heat, Heat sterilization, Humid, Hygiene, Information, Inspection, Instructions, Instrumentation, Large scale equipment, Maintenance, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Methods, Moisture, Operation, Packages, Performance, Personnel, Products, Public health, Public health protection, Qualifications, Quality management, Repair, Routine tests, Sanitary engineering, Specification (approval), Steam, Steam sterilization, Steam sterilizers, Sterilization by irradiation, Sterilization (hygiene), Sterilized goods, Sterilizers, Surveillance (approval), Testing, Validation, Verification
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