DIN EN ISO 12417-1
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Medizinprodukt-Arzneimittel-Kombinationsprodukte - Teil 1: Allgemeine Anforderungen (ISO 12417-1:2024); Deutsche Fassung EN ISO 12417-1:2024
Overview
This document has been prepared by Technical Committee ISO/TC 150 "Implants for surgery" in cooperation with Technical Committee CEN/TC 285 "Non-active surgical implants", the secretariat of which is held by DIN. This document has been prepared in order to provide minimum requirements for vascular device-drug combination products (VDDCPs). This standard deals only with aspects of vascular medical devices to be used in combination with medicinal products in which the medicinal product serves an additional function of the VDDCP.
Document: references other documents
Responsible national committee
NA 027-05-06 AA - Cardiovascular implants
Responsible european committee
CEN/TC 285 - Non-active surgical implants
Responsible international committee
ISO/TC 150/SC 2/WG 6 - Vascular device-drug combination products
