Suchen in:
Warenkorb (0)
Standard

ISO/TR 12417-2:2022

Aktuell
Vorschau

Bestehende oder zukünftige Amendments und Versionen müssen separat erworben werden.

Sprache
Format

Zusammenfassung

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.

Produktspezifikationen

  • Standard von ISO
  • Ausgabedatum:
  • Edition: 2
  • Dokumenttyp: TR
  • Seiten
  • Herausgeber: ISO
  • Lieferant: ISO
  • ICS: 11.040.40
  • Internationales Komitee: ISO/TC 150/SC 2

Produktbeziehungen

Produktlebenszyklus