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ISO/TR 12417-2:2022

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information
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ISO/TR 12417-2:2022

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information

PUBLISH DATE 2022
ISO/TR 12417-2:2022

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.

SDO ISO: International Organization for Standardization
Document Number ISO/TR 12417
Publication Date July 1, 2022
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 150/SC 2
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