Name:
ISO/TR 12417-2:2017 PDF
Published Date:
11/01/2017
Status:
Active
Publisher:
International Organization for Standardization (Technical Report)
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.
| File Size : | 1 file , 500 KB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 36 |
| Published : | 11/01/2017 |
