Numéro de référence
ISO/TR 12417-2:2017
© ISO 2025
Rapport technique
ISO/TR 12417-2:2017
Implants cardiovasculaires et circuits extra-corporels — Produits de combinaison médicament-dispositif vasculaire — Partie 2: Directives règlementaires locales
Edition 1
2017-11
Annulée
Annulée (Edition 1, 2017)

Résumé

ISO/TR 12417-2:2017 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 the 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.

ISO/TR 12417-2:2017 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. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.

Informations générales

  • État actuel
     : Annulée
    Date de publication
     : 2017-11
    Stade
    : Annulation de la Norme internationale [95.99]
  • Edition
     : 1
  • Comité technique :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
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