DANSK DS/EN ISO 12417-1 PDF

1.1 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. NOTE Due to variations in the design of products covered by this standard 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 standard will be necessary. 1.2 Delivery systems or parts of the delivery system are included in the scope of this standard 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). 1.3 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 standard. 1.4 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 standard if they do not affect the drug-related aspects of the device. 1.5 This standard 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 standard. 1.6 Bioabsorbable components of VDDCPs (e.g. coatings) are addressed by this standard in their connection with drug-related aspects of the device. Degradation and other time-dependent aspects of bioabsorbable implants and coatings are not addressed by this part of ISO 12417. 1.7 This standard does not address issues associated with viable tissues and non-viable biological materials.