ANSI/AAMI/ ISO 14708-5: 2010 pdf download – Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices.
6 Requirements for particular active implantable medical devices Addition 6.101 Intended clinical use/indications The intended use and indications for the device system shall be described. The intended use describes what the device system does (e.g. provides circulatory support) and where it may be used safely (e.g. hospital, home, ground and/or air transport vehicles). The indications are the disease(s) or condition(s) the device will diagnose, treat, prevent, cure, or mitigate and a description of the target population for which the device is intended without causing unreasonable risk of illness or injury associated with use of the device. 6.102 System description 6.102.1 General A comprehensive description of the system should be documented, including discussions on the principle(s) of operation, design consideration(s), system configuration(s), system component(s), and system performance and operating limits. Design specifications for the complete system include the full range of system operating limits for each parameter (e.g. beat rates, E/F ratio, rotation speeds, power), system operational modes (e.g. manual, automatic), system component configurations (e.g. hospital, home, power sources, optional display, optional subsystems, optional console), alarm thresholds, and all associated tolerances on each of these parameters. 6.102.2 Principle of operation A discussion of the operating principle of the system should include the blood pumping mechanism, connections to the cardiovascular system, power system, and control mechanisms.
6.102.3 Design consideration The rationale for key design choices should be given. This should include, but is not limited to, approaches taken to minimize blood component damage, methods for thermal management, choice of drive mechanisms, a power management scheme, reliability considerations, adequacy of anatomic fit, and patient interaction. 6.102.4 System configuration A detailed physical description of the system shall be given including implantation sites of various implantable components, external wearable units, and external consoles. Size, shape, weight, and volume of the components should be given, as well as the different configurations of system components that can be used to provide support. 6.102.5 System performance and operating limits The entire performance range of the system shall be given, even if some operation conditions are not expected to be used clinically or might cause the system to malfunction.