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NA 027

DIN Standards Committee Optics and Precision Mechanics

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Standards [CURRENT]

DIN EN ISO 12417-1
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

Title (German)

Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Medizinprodukt-Arzneimittel-Kombinationsprodukte - Teil 1: Allgmeine Anforderungen (ISO 12417-1:2015); Deutsche Fassung EN ISO 12417-1:2015

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.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 027-05-06 AA - Cardiovascular implants  

Responsible european committee

CEN/TC 285 - Non-active surgical implants  

Edition 2016-02
Original language German
Translation English
Price from 158.40 €
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