Standard

ISO/TR 12417-2:2017

Radié

Note: Version actuelle: ISO/TR 12417-2:2022

Amendements et versions existants ou nouveaux doivent être achetés séparément.

Langue
Format

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.

Spécifications des produits

  • Standard de ISO
  • Publié:
  • Radié:
  • Version: 1
  • Type de document: TR
  • Pages
  • Editeur: ISO
  • Distributeur: ISO
  • ICS: 11.040.40
  • Comité international: ISO/TC 150/SC 2

Relations produit

Cycle de vie du produit