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
German title
Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Medizinprodukt-Arzneimittel-Kombinationsprodukte - Teil 1: Allgemeine Anforderungen (ISO 12417-1:2024); Deutsche Fassung EN ISO 12417-1:2024
Publication date
2024-08
Original language
German
Pages
68
Publication date
2024-08
Original language
German
Pages
68
DOI
https://dx.doi.org/10.31030/3530247
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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.
Please get in touch with the relevant contact person at DIN if you have problems understanding the content of the standard or need advice on how to apply it.