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Standard

ISO/TR 12417-2:2017

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: ISO/TR 12417-2:2022

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Omfang

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.

Dokumentinformasjon

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

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