BS EN ISO 12417-1:2015 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 substance or product (drug substance, drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action (PMOA) of the device. With regard to safety, this part of ISO 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this International Standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This International 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 part of ISO 12417 also address VDDCPs that are not permanent implants.

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. drugcovered 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 drugrelated aspects of the device.

This part of ISO 12417 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.

This part of ISO 12417 does not address issues associated with viable or non-viable biological materials such as tissues, cells, or proteins.

This part of ISO 12417 does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).


Cross References:
ISO 10993-1
ISO 10993-2
ISO 10993-7
ISO 11070
ISO 11607-1
ISO 14155
ISO 14630:2012
ISO 14937
ISO 14971:2007
ISO 15223-1
ISO 25539-2
ISO 10993
ISO 13485
ISO 15223
ISO 17665-1
ISO/IEC 17025
ISO 5832
ISO 5840
ISO 5841-2
ISO 7198
ISO 7199
ISO 10555-1
ISO 10555-2
ISO 10555-3
ISO 10555-4
ISO 13781
ISO 13960
ISO 14160
ISO/TR 14283
ISO/TS 15539
ISO 15814
ISO 16054
ISO 16428
ISO 16429
ISO 17475
ISO 25539-1
ISO 25539-3
ISO/TS 17137
GHTF/SG1/N071
ICH Q1A(R2)
ICH Q1B(R2)
ICH Q1D
ICH Q1E
ICH Q3A(R)
ICH Q3B(R2)
ICH Q3C (R5)
ICH Q3D
ICH Q6A
ICH Q7
ICH S1A
ICH S1B
ICH S1C(R2)
ICH S2(R1)
ICH S3A
ICH S3B PK
ICH S4
ICH S5(R2)
ICH S6(R1)
ICH S7A
ICH S7B
ICH S8
ICH M3(R2)
ICH M4(R3)
ANSI/AAMI ST67
ASTM B117
ASTM D638
ASTM F746
ASTM F2052
ASTM F2079
ASTM F2081
ASTM F2119
ASTM F2129
ASTM F2182
ASTM F2213
ASTM F2394
ASTM F2503
ASTM G5
ASTM G15
ASTM G61
ASTM G102
EN 556


All current amendments available at time of purchase are included with the purchase of this document.