标准编号：ISO 12417-1:2015
中文名称：心血管植入物和体外系统 血管装置 药物组合产品 第1部分：一般要求
英文名称：Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
发布日期：2015-10
标准范围
This part of ISO 12417 specifies requirements for vascular device-drug combination products (VDDCPs)based upon current technical and medical knowledge. VDDCPs are medical devices with various clinicalindications 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 (drugsubstance, drug product) but the action of the medicinal substance is ancillary to that of the device andsupports the primary mode of action (PMOA) of the device. With regard to safety, this part of ISO 12417outlines requirements for intended performance, design attributes, materials, design evaluation,manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implantedproducts, this International Standard should be considered as a supplement to ISO 14630, whichspecifies general requirements for the performance of non-active surgical implants. This InternationalStandard should also be considered as a supplement to relevant device-specific standards, such as theISO 25539?series specifying requirements for endovascular devices. Requirements listed in this part ofISO 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 dueto the relatively recent development of some of these combination products, acceptable standardized in vitrotest results and clinical study results are not always available. As further scientific and clinical data becomeavailable, 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, ifthey comprise an integral component of the vascular device and if they are drug-covered (e.g. drugcoveredballoon catheters and drug-covered guidewires).Devices whose PMOA is to provide a conduit for delivery of a drug, are excluded from the scope of thispart of ISO 12417 (e.g. infusion catheters), unless they contain a drug component that is intended tohave 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. balloonangioplasty devices) are excluded from the scope of this part of ISO 12417 if they do not affect the drugrelatedaspects 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 theirconnection with drug-related aspects of the device. Degradation and other time-dependent aspects ofabsorbable 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 materialssuch as tissues, cells, or proteins.
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