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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.


Общая информация 

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2022-07
  • Версия
     : 2
  • Технический комитет
     : ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
  • ICS
     :
    11.040.40 Implants for surgery, prosthetics and orthotics

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  2. Интернет-магазин
  3. Каталог стандартов
  4. ТК
  5. ISO/TC 150/SC 2
  6. ISO/TR 12417-2:2022