Standards Update The ISO/TC 150/SC 2/WG 3 met in Scottsdale, AZ in February to begin developing the working draft of ISO 25539-2 for Arterial Stents. The committee is made up primarily of the same representatives as the ISO 25539-1 (Vascular Prosthesis). The working draft of the amendment to the ISO 25539-1 document from the Vascular Prosthesis committee was sent to ballot after the last International Standards meeting in Delft, The Netherlands. The AAMI Vascular Prosthesis committee is currently reviewing the document to determine the US position on it. A new FDA chairperson has initiated developments in the ASTM Interventional Cardiology Task Group. Vivian Holt has been very active in generating documents to help the industry and FDA set guidelines for testing. As a result, some documents are ready for balloting this summer; if you would like to make comments on the ballots please visit the ASTM website at www.ASTM.org. This group has also begun work to develop guidelines and test methods for testing coated stents. This area is very new and there is little to help either side of the industry in determining acceptable testing criteria. At the last meeting in Rockville, the group began to lay out the tests that might be appropriate for coated devices. Any input in this area is greatly appreciated. If you would like more information on this group, please feel free to contact us.
