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
Abstract
This document specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal substance or product (drug substance, drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action (PMOA) of the device. With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this International Standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This International Standard should also be considered as a supplement to 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 permanent implants.
Begin
2020-11-09
WI
00285140
Planned document number
DIN EN ISO 12417-1
Project number
02703280
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
draft standard
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO/DIS 12417-1:2021); German and English version prEN ISO 12417-1:2021
2021-11
Order from DIN Media
