ISO/TR 12417-2:2022
2022-07
ISO/TR 12417-2:2022
Résumé
This document provides region-specific information for:
— local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;
— changes related to the drug-containing part and how they are evaluated by different local regions.
For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
This document is considered also as a supplement to ISO 12417-1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. This document also addresses VDDCPs that are not necessarily permanent implants.
Informations générales
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État actuel: PubliéeDate de publication: 2022-07Stade: Norme internationale publiée [60.60]
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Edition: 2
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Comité technique :ISO/TC 150/SC 2ICS :11.040.40
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Cycle de vie
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Précédemment
AnnuléeISO/TR 12417-2:2017
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Actuellement
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