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Normas DIN – AENOR
DIN EN ISO 14971:2001-03

DIN EN ISO 14971:2001-03

Medical devices - Application of risk management to medical devices (ISO 14971:2000); German version EN ISO 14971:2000

Dispositif médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2000); Version allemande EN ISO 14971:2000

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2000); Deutsche Fassung EN ISO 14971:2000

Fecha Anulación:
2017-07 /Withdrawn
Equivalencias internacionales:

EN ISO 14971 (2000-12)

ISO 14971 (2000-12)

SN EN ISO 14971 (2001-02)

Relación con otras normas DIN:

Modificada por: DIN EN ISO 14971/A1:2003-10

Reemplaza a: DIN EN 1441:1998-01

Reemplazada por: DIN EN ISO 14971:2007-07

Resumen:
The document specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories including in vito diagnostic medical devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control.
Das Dokument legt für den Hersteller ein Verfahren fest, mit dem er Gefährdungen, die mit Medizinprodukten und ihrem Zubehör verbunden sind, einschließlich In-Vitro-Diagnostik, erkennt, die Risiken abschätzt, bewertet und kontrolliert, und die Wirksamkeit dieser Kontrolle überwacht.
Keywords:
Acceptance, Accessories, Analysis, Applications, Assessment, Biological hazards, Checks, Components, Contact, Context, Creation, Definitions, Diagnosis, Dotted lines, Electrical hazards, Energy, Environmental hazards, Establishment, Evaluations, Examination (quality assurance), Handling, Hazards, Health hazards, In vitro, In-vitro diagnostic, Loss, Management, Materials, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Methods, Personal health, Properties, Public health, Qualitative, Quantitative, Risk, Risk analysis, Risk estimation, Safety, Safety measures, Safety tests, Specification (approval), Toxicological hazards, Use
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