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Normas DIN – AENOR
DIN EN ISO 14971/A1:2003-10

DIN EN ISO 14971/A1:2003-10

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AMD 1:2003); German version EN ISO 14971:2001/A1:2003

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux; Amendement 1: Justification des exigences (ISO 14971:2000/AMD 1:2003); Version allemande EN ISO 14971:2001/A1:2003

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte - Änderung 1: Begründung der Anforderungen (ISO 14971:2000/AMD 1:2003); Deutsche Fassung EN ISO 14971:2001/A1:2003

Fecha Anulación:
2017-07 /Withdrawn
Equivalencias internacionales:

EN ISO 14971/A1 (2003-03)

ISO 14971 AMD 1 (2003-03)

Relación con otras normas DIN:
Resumen:
This corrigenda contains the informative Annex H of DIN EN ISO 14971 with the rationale for the requirements. It does not contain additional requirements.
Diese Berichtigung enthält den informativen Anhang H zu DIN EN ISO 14971 mit der Begründung der Anforderungen. Sie enthält keine zusätzlichen Anforderungen.
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, Personnel, Properties, Public health, Qualifications, Qualitative, Quantitative, Risk, Risk analysis, Risk estimation, Safety, Safety measures, Safety tests, Specification (approval), Toxicological hazards, Use
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