BS PD ISO/TR 12417-2:2022

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products-Local regulatory information

BSI Group , 07/15/2022

Publisher: BS

File Format: PDF

$155.00$310.00


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.

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