60.60 Standard published Jul 7, 2022
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
Technical Report
11.040.40 Implants for surgery, prosthetics and orthotics
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.
WITHDRAWN
ISO/TR 12417-2:2017
PUBLISHED
ISO/TR 12417-2:2022
60.60
Standard published
Jul 7, 2022