NOTE Due to variations in the design of combination products covered by this part of ISO 12417 and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 12417 might be necessary.
Delivery systems or parts of the delivery system are included in the scope of this part of ISO 12417, 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).
Devices whose PMOA is to provide a conduit for delivery of a drug, are excluded from the scope of this part of ISO 12417 (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter).
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 part of ISO 12417 if they do not affect the drug-related aspects of the device.
ISO 12417-1:2015 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different national and regional authorities is given in Annex B.
Absorbable components of VDDCPs (e.g. coatings) are addressed by this part of ISO 12417 in their connection with drug-related aspects of the device. Degradation and other time-dependent aspects of absorbable implants and coatings are not completely addressed by this part of ISO 12417.
NOTE See also ISO/TS 17137 and ASTM F3036-13.
ISO 12417-1:2015 does not address issues associated with viable or non-viable biological materials such as tissues, cells, or proteins.
ISO 12417-1:2015 does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).