Outline of the International Organization for Standardization Standard for Circulatory Support Devices (ISO 14708-5).
The rapid progress of artificial heart and circulatory support devices enables us to apply them to severe heart failure patients. Many types of circulatory support devices have been developed in the United States, Europe, and Japan. This situation urged the establishment of an International Organization for Standardization (ISO) Standard for the circulatory support devices. A new work, "Cardiac Ventricular Assist Devices," was proposed to the ISO/TC150/SC6 (TC150: Technical Committee of Implants for Surgery, SC6: Sub-committee of Active Implants) in 2000, and the work was finalized for publication at a 2009 meeting of the ISO/TC150 in Kyoto. In this article, the authors would like to introduce the ISO system and the outline of the ISO Standard for Circulatory Support Devices.
Imachi
Kou
K
Department of Biomedical Engineering, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. imachi@bme.gr.jp
Mussivand
Tofy
T
D003299:Cooperative Behavior; D017408:Guidelines as Topic; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D007390:International Agencies / Q000458:organization & administration / Q000592:standards*; D007391:International Cooperation; D011474:Prosthesis Design