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Normas DIN – AENOR
DIN EN ISO 14971:2009-10

DIN EN ISO 14971:2009-10

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009 / Note: DIN EN ISO 14971 (2007-07) and DIN EN ISO 14971 Berichtigung 1 (2007-10) remain valid alongside this standard until 2010-03-21.

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007, Version corrigée de 2007-10-01); Version allemande EN ISO 14971:2009 / Attention: DIN EN ISO 14971 (2007-07) et DIN EN ISO 14971 Berichtigung 1 (2007-10) restent valable avec la présente norme jusqu'à 2010-03-21.

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2007, korrigierte Fassung 2007-10-01); Deutsche Fassung EN ISO 14971:2009 / Achtung: Daneben gelten DIN EN ISO 14971 (2007-07) und DIN EN ISO 14971 Berichtigung 1 (2007-10) noch bis 2010-03-21.

Fecha Anulación:
2013-04 /Withdrawn
Equivalencias internacionales:

EN ISO 14971 (2009-07)

ISO 14971 (2007-03)

Relación con otras normas DIN:
Resumen:
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Keywords:
Acceptance, Accessories, Analysis, Applications, Assessment, Biological hazards, CE marking, Characteristics, Checks, Components, Contact, Context, Creation, Definitions, Diagnosis, Dotted lines, Electrical hazards, Energy, English language, Environmental hazards, Establishment, Evaluations, Examination (quality assurance), Guide books, 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, Personnel, Planning, Production, Properties, Public health, Qualifications, Qualitative, Quality management, Quantitative, Risk, Risk analysis, Risk estimation, Safety, Safety measures, Safety tests, Specification (approval), Surveillance (approval), Toxicological hazards, Use
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