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Normas DIN – AENOR
DIN EN ISO 20857:2013-08

DIN EN ISO 20857:2013-08

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013

Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la validation et le contrôle de routine d'un processus de stérilisation pour dispositifs médicaux (ISO 20857:2010); Version allemande EN ISO 20857:2013

Sterilisation von Produkten für die Gesundheitsfürsorge - Trockene Hitze - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 20857:2010); Deutsche Fassung EN ISO 20857:2013

Fecha:
2013-08 /Active
Equivalencias internacionales:

EN ISO 20857 (2013-04)

ISO 20857 (2010-08)

Relación con otras normas DIN:
Resumen:
This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. This International Standard specifies requirements and provides guidance in relation to depyrogenation processes using dry heat. 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. This International Standard does not apply to processes that use infrared or microwaves as the heating technique. This International Standard does not detail a specified requirement for designating a medical device as "sterile". This International Standard does not specify a quality management system for the control of all stages of production of medical devices. This International Standard does not specify requirements for occupational safety associated with the design and operation of dry heat sterilization and/or depyrogenation facilities.
Keywords:
Checks, Control method, Control test, Definitions, Developments, Dry heat, Dry-heat tests, Industrial, Medical devices, Medical products, Medical sciences, Processes, Public health, Quality management, Quality requirements, Routine tests, Safety requirements, Specification (approval), Sterile technology, Sterilization (hygiene), Validation
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