ISO/TR 12417-2:2022
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ISO/TR 12417-2:2022
80895

Abstract

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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.


General information 

  •  :  Published
     : 2022-07
  •  : 2
     : 29
  •  : ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
  •  :
    11.040.40 Implants for surgery, prosthetics and orthotics

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