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Normas DIN – AENOR
DIN EN ISO 12417-1:2014-06

DIN EN ISO 12417-1:2014-06

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products (ISO/DIS 12417-1:2014); German version prEN ISO 12417-1:2014 / Note: Date of issue 2014-05-09

Implants cardiovasculaires et systèmes extracorporels - Produits de combinaison médicament-dispositif vasculaire (ISO/DIS 12417-1:2014); Version allemande prEN ISO 12417-1:2014 / Attention: Date de parution 2014-05-09

Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Medizinprodukt-Arzneimittel Kombinationsprodukte (ISO/DIS 12417-1:2014); Deutsche Fassung prEN ISO 12417-1:2014 / Achtung: Erscheinungsdatum 2014-05-09

Fecha Anulación:
2016-02 /Withdrawn
Equivalencias internacionales:

ISO/DIS 12417-1 (2014-04)

prEN ISO 12417-1 (2014-04)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 12417-1:2016-02

Resumen:
This standard 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 product (drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action of the device. With regard to safety, this Standard outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This 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 standard also address VDDCPs that are not necessarily permanent implants.
Keywords:
Cardiology, Cardiovascular systems, Combination, Definitions, Design, Drug control, Drugs, Effects, Extracorporeal, Implants (surgical), Materials, Medical products, Medical technology, Minimum requirements, Packages, Pharmaceuticals, Specification (approval), Sterilization (hygiene)
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