NF EN ISO 12417-1, S94-710-1 (02/2024)

This document specifies requirements for vascular drug-device combination products (VDDCP). In terms of safety, this document sets out requirements for intended performance, design characteristics, materials, design evaluation, manufacturing, sterilization, packaging and information provided by the maker. For implanted products, this document is intended to be used as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is intended to be used as a supplement to relevant device-specific standards, including the ISO 25539 series - which specifies requirements for endovascular devices. The requirements listed in this document also apply to VDDCPs that are not permanently established. NOTE 1 Due to design variations among the combination products covered by this document and due to the relatively recent development of some of these products, in vitro test results are not always available acceptable standards or clinical study results available. As new scientific and clinical data become available, it may be necessary to make an appropriate revision of this document. This document applies to delivery systems or parts of the delivery system that are an integral part of the vascular device and that are drug-coated (e.g., drug-coated balloon catheters or drug-coated guidewires). This document does not apply to devices whose PMOA is the provision of a conduit for the administration of a drug (e.g., infusion catheters), unless they contain a drug component whose action is auxiliary to that of the device (for example, antimicrobial coated infusion catheter). This document does not apply to procedures and devices used before and after the introduction of VDDCP (e.g. percutaneous transluminal angioplasty devices) if they do not impact the medicinal aspects of the device. This document does not provide a comprehensive pharmacological evaluation of VDDCPs. NOTE 2 Information relating to the requirements of certain national and regional authorities is given in Annex B. The relationship between the absorbable components of VDDCPs (e.g. coatings) and the medicinal aspects of the device is addressed in this document. This document does not provide an exhaustive list of degradation and other temporal aspects relating to implants and absorbable coatings. NOTE 3 For more information on absorbable coatings, refer to ISO/TS 17137 and ASTM F3036-13. This document does not address issues related to viable or non-viable biological materials, such as tissues, cells or proteins. This document does not address issues related to active surgical implants (i.e., implants requiring energy not produced by the human body or gravity).
(Automatic translation from French)