EVS-EN ISO 12417-1:2015

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.
1.7This  standard  does  not  address  issues  associated  with  viable  tissues  and non-viable  biological materials.