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Normas DIN – AENOR
DIN ISO/TS 17665-2:2009-07

DIN ISO/TS 17665-2:2009-07

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009); German version CEN ISO/TS 17665-2:2009

Stérilisation des produits de santé - Chaleur humide - Partie 2: Directives relatives à l'application de l'ISO 17665-1 (ISO/TS 17665-2:2009); Version allemande CEN ISO/TS 17665-2:2009

Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 2: Leitfaden für die Anwendung von ISO 17665-1 (ISO/TS 17665-2:2009); Deutsche Fassung CEN ISO/TS 17665-2:2009

Fecha:
2019-07 /Active
Equivalencias internacionales:

CEN ISO/TS 17665-2 (2009-01)

ISO/TS 17665-2 (2009-01)

TSE CEN ISO/TS 17665-2 (2013-02-21)

Resumen:
This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1:2006. The guidance given in this Technical Specification is provided to promote good practices practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1.
Keywords:
Acceptance (approval), Checks, Commissioning, Definitions, Examination (quality assurance), Germicides, Heat, Heat sterilization, Hygiene, Inspection, Instructions, Large scale equipment, Maintenance, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Methods, Moisture, Operation, Packages, Performance, Personnel, 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, Thermal processes, Validation, Verification
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