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
Edition 2
2022-07
© ISO 2024
International Standard
Read sample
Published (Edition 2, 2022)

ISO/TR 12417-2:2022

Format
Language
CHF 151
Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2022-07
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 29
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
  • RSS updates

Life cycle

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. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.040
  7. 11.040.40
  8. ISO/TR 12417-2:2022