ISO/TR 12417-2:2017
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
Referenced standards
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
ISO/TR 12417-2:2017 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 the 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.
ISO/TR 12417-2:2017 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. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.
| Edition | 2017 |
|---|---|
| Standard Part No | 2 |
| Published Date | 2017 |
| Published By | International Standardization Organisation/Technical Reference |
| Page Count | 29 |