Abstract

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.


General information 

  • Status
     : Withdrawn
    Publication date
     : 2017-11
  • Edition
     : 1
    Number of pages
     : 29
  • Technical Committee
     : ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
  • ICS
     :
    11.040.40 Implants for surgery, prosthetics and orthotics

Life cycle

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.040
  7. 11.040.40
  8. ISO/TR 12417-2:2017