Norm

NPR-ISO/TR 12417-2:2017 en

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information

124,99 151,24 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 29
Commissie Chirurgische implantaten
Gepubliceerd op 01-12-2017
Taal Engels
NPR-ISO/TR 12417-2 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. 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. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.

Details

ICS-code 11.040.40
Engelse titel Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information

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