Résumé
Pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment. Specifies the requirements for conducting the clinical investigation and documentation. Provides the framework for systematic written procedures for the organization, design, implementation and data collection.
Informations générales
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État actuel: AnnuléeDate de publication: 1996-02Stade: Annulation de la Norme internationale [95.99]
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Edition: 1Nombre de pages: 13
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Comité technique :ISO/TC 194ICS :11.100
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Cycle de vie
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Actuellement
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Révisée par
AnnuléeISO 14155-1:2003
AnnuléeISO 14155-2:2003