EUROLAB laboratory provides testing and compliance services within the scope of ISO 12417 standard. ISO 12417 specifies requirements for vascular device-drug combination products (VDDCPs) based on available technical and medical knowledge.
VDDCPs are medical devices with a variety of clinical indications for use in the human vascular blood system. A VDDCP, as an integral part, contains substances that can be considered a medicinal substance or product (drug substance, drug product) when used separately, but whose action of the medicinal substance aids that of the device and supports the device's primary mode of action (PMOA).
Regarding safety, ISO 12417 outlines requirements for intended performance, design features, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information. For implanted products, this International standard should be considered in addition to ISO 14630, which sets general requirements for the performance of inactive surgical implants.
This International standard should also be considered in addition to relevant device-specific standards, such as the ISO 25539‑series, which sets requirements for endovascular devices. The requirements listed in ISO 12417 also address non-permanent implant VDDCPs.
Devices whose PMOA will provide a channel for the delivery of a drug are outside the scope of ISO 12417 (for example, infusion catheters) unless they contain a drug component intended to have an ancillary effect on the device part (for example, an antimicrobial-coated infusion catheter).
Procedures and devices (e.g. balloon angioplasty devices) used before and after the introduction of VDDCP are outside the scope of ISO 12417 unless they affect the drug-related aspects of the device.
EUROLAB assists manufacturers with ISO 12417 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
