Full Description

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.

Product Details

Published: 07/31/2022 ISBN(s): 9780539184716 Number of Pages: 38 File Size: 1 file , 1.6 MB Same As: ISO/TR 12417-2:2022 Product Code(s): 30440681, 30440681, 30440681 Note: This product is unavailable in Ukraine, Russia, Belarus