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Standard

ISO/TR 12417-2:2022

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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.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • Utgave: 2
  • Versjon: 1
  • Varetype: TR
  • Products.Specs.pages
  • ICS 11.040.40
  • ISO TC ISO/TC 150/SC 2

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