DIN EN ISO 12417-1:2024-08
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
| Fecha edición: |
2024-08-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | 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. |
| Keywords: | Blood|Cardiology|Cardiovascular systems|Combination|Definitions|Design|Drug control|Drugs|Effects|Extracorporeal|Functions|Implants (surgical)|Information supplied by the manufacturer|Materials|Medical devices|Medical products|Medical technology|Minimum requirements|Packages|Pharmaceuticals|Production|Specification (approval)|Sterilization (hygiene)|Vascular |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 12417-1:2024 Idéntica ISO 12417-1:2024 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 12417-1:2016-02 Reemplaza a DIN EN ISO 12417-1:2021-11 |
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