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Normas DIN – AENOR
DIN EN ISO 12417-1:2016-02

DIN EN ISO 12417-1:2016-02

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

Implants cardiovasculaires et circuits extra-corporels - Produits de combinaison médicament-dispositif vasculaire - Partie 1: Exigences générales (ISO 12417-1:2015); Version allemande EN ISO 12417-1:2015

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

Fecha:
2016-02 /Active
Equivalencias internacionales:

EN ISO 12417-1 (2015-10)

ISO 12417-1 (2015-10)

Relación con otras normas DIN:
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 devices, Medical products, Medical technology, Minimum requirements, Packages, Pharmaceuticals, Specification (approval), Sterilization (hygiene)
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