Reference number
ISO/TR 12417-2:2022
© ISO 2024
Technical Report
ISO/TR 12417-2:2022
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
Edition 2
2022-07
Technical Report
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Published (Edition 2, 2022)

ISO/TR 12417-2:2022

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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 
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