ABSTRACT
The development of blood pumps goes through design steps, prototype construction, in vitro evaluation, in vivo evaluation, clinical evaluation, and release for use. These items are included in the international standard ISO 14708—Implants for Surgery—Active implantable medical devices—Part 5: Circulatory support devices, 2010. This standard deals with a regulatory item of definitions, specifications, tests, and documentation for the development of all procedures and is already applied in Brazil as ABNT NBR ISO 14708-5: 2017. Regarding the development (geometry and dimensions), the standard is not specific. It shows a methodology of step-by-step development, based on the progression of experiments and improvement of the project through preliminary results, the same proposed by Dr. Nosé in 1998. In other words, the development is at the discretion of the ideology of the researcher, and from the results of the tests proposed by ISO 14708-5, changes are made in the project, which may result in a product different from the original and even for other applications.
In this chapter, the theoretical framework for better understanding the process of ventricular assist device (VAD) design will be presented.
