International Standard
ISO/TR 12417-2:2022
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
Reference number
ISO/TR 12417-2:2022
Edición 2
2022-07
© ISO 2024
International Standard
Vista previa
No disponible en español
Publicado (Edición 2, 2022)

ISO/TR 12417-2:2022

Formato
Idioma
CHF 151
Convertir Franco suizo (CHF) a tu moneda

Resumen

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.

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2022-07
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 2
    Número de páginas
     : 29
  • Comité Técnico :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
  • RSS actualizaciones

Ciclo de vida

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Tienda
  3. Standards catalogue
  4. TC
  5. ISO/TC 150/SC 2
  6. ISO/TR 12417-2:2022