DD ISO/TS 12417:2011 - Page 2

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. | Status: Superseded, Withdrawn

1 Scope 1.1 This Technical Specification 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 Technical Specification outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information supplied by the manufacturer. For implanted products, this Technical Specification should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This Technical Specification 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 Technical Specification also address VDDCPs that are not necessarily permanent implants.

NOTE Due to variations in the design of products covered by this Technical Specification and due to the relatively recent development of some of these products, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this Technical Specification will be necessary.