Norme internationale
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
Publié 7 juil. 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.
Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.
Retirée · 21 nov. 2017