New ISO/TS 12417 covers Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products

ISO/TS 12417, titled “Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products,” has just been issued as the new 1st Edition.  These combination products are medical devices with various clinical indications for use in the human vascular blood system.

A ISO/TS is actually an ISO technical specification.  It offers a technical solution to a particular problem,  without conflicting with existing International Standards.  For implanted products, ISO/TS 12417 should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. ISO/TS 12417 should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539-1 and ISO 25539-2 series specifying requirements for endovascular devices. Requirements listed in ISO/TS 12417 also address VDDCPs that are not necessarily permanent implants.

ISO/TS 12417:2011 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action of the device.

With regard to safety, ISO/TS 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information supplied by the manufacturer.

Delivery systems or parts of the delivery system are included in the scope of ISO/TS 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).

Pumps and infusion catheters which do not contain drug coverings, and whose primary mode of action is to deliver a drug, are not addressed in ISO/TS 12417.

Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of ISO/TS 12417 if they do not affect the drug-related aspects of the device.

ISO/TS 12417 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different related national and regional authorities is given in an annex.

Bioabsorbable components of VDDCPs (e.g. coatings) are addressed by ISO/TS 12417 in their connection with drug-related aspects of the device.

ISO/TS 12417 does not address issues associated with viable tissues and non-viable biological materials.

This standard, and all ISO standards, are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our expert staff can assist you with all your standards requirements and questions.

 

Medical Device Standards – The Top 10 Standards on Vascular Stents

Vascular stents are the tubes that are placed in blood vessels to improve the flow of blood, either by preventing or counteracting a localized flow constriction.  Standards for those stents have been in force since the beginning of the 21st century.  Here are our top ten standards on the subject:

ASTM-F2079, Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

ASTM-F2081, Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM-F2394, Standard Guide for Measuring  Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

ASTM-F2477, Standard Test Method for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM-F2514, Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM-F2606, Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

ANSI/AAMI/ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

BS-EN-ISO-25539-2, Cardiovascular Implants – Endovascular Devices –  Vascular Stents

All of the above standards can be purchased from Document Center Inc.  Buy them at www.document-center.com, or phone 650-591-7600, fax 650-591-7617, or email info@document-center.com.