ANSI AAMI ISO 14708-5:2010 pdf download – Implants for surgery – Active implantable medical devices
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.
6.104 Risk analysis
Risk analysis, part of the risk management process, should be performed on the system. The risk analysis should include a top-down analysis (such as a hazard analysis or fault tree analysis, FTA), a bottom up analysis (such as failure mode, effects, and criticality analysis, FMECA), as well as an analysis for potential use or user error (human factors analysis). The risk analysis should utilize a method to classify the severity of failure modes, the probability of occurrence, the risk priority number, and the detection method. The analysis should include discussion of methods used to mitigate the criticality of the failure modes (see 1 9.2). NOTE For further information on risk analysis, see ISO 1 4971 .
6.105 Human factors
Human factors evaluation should consist of both integrated system testing and subsystem testing. The user interface, both hardware and software, should be designed to be understandable and compatible with the intended users’ anticipated capabilities (e.g. physical, mental, or sensory) to reduce the likelihood of error and/or confusion. Further, appropriate alarms and warnings are necessary and shall be designed to warn users of system or subsystem failures. Guidance for human factors can be found in IEC 62366.