ISO TS 12417
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products
|Publication Date:||1 June 2011|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
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.
Delivery systems or parts of the delivery system are included in the scope of this Technical Specification if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).
Pumps and infusion catheters which do not contain drug coverings, and whose primary mode of action is to deliver a drug, are not addressed in this Technical Specification.
Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of this Technical Specification if they do not affect the drugrelated aspects of the device.
This Technical Specification is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different related national and regional authorities is given in Annex B of this Technical Specification.
Bioabsorbable components of VDDCPs (e.g. coatings) are addressed by this Technical Specification in their connection with drug-related aspects of the device.
This Technical Specification does not address issues associated with viable tissues and non-viable biological materials.