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ISO/TR 12417-2:2017

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Hinweis: Neuste Ausgabe: ISO/TR 12417-2:2022

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Zusammenfassung

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.

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  • Standard von ISO
  • Ausgabedatum:
  • Rückzugsdatum:
  • Edition: 1
  • Dokumenttyp: TR
  • Seiten
  • Herausgeber: ISO
  • Lieferant: ISO
  • ICS: 11.040.40
  • Internationales Komitee: ISO/TC 150/SC 2

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