Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015); German version EN ISO 12417-1:2015
German title
Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Medizinprodukt-Arzneimittel-Kombinationsprodukte - Teil 1: Allgmeine Anforderungen (ISO 12417-1:2015); Deutsche Fassung EN ISO 12417-1:2015
Publication date
2016-02
Original language
German
Pages
71
Publication date
2016-02
Original language
German
Pages
71
DOI
https://dx.doi.org/10.31030/2308514
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Overview
This standard 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 International Standard 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.