PRICES include / exclude VAT
Not available online - contact us!
download between 0-24 hoursReleased: 2017
ISO/TR 12417-2:2017
Cardiovascular implants and extracorporeal systems
CURRENCY
Standard´s number: | ISO/TR 12417-2:2017 |
Pages: | 29 |
Edition: | 1 |
Released: | 2017 |
Language: | English |
DESCRIPTION
ISO/TR 12417-2:2017
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.