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.
6.102.1 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 .
6.106.1 Objective
In vitro testing shall include design characterization of the integrated system and its individual system subcomponents against all of its system design specifications. Test set-ups should be reasonably representative of the intended patient population in which pressures, compliances and flow should be at appropriate values. A description of the in vitro testing systems, including all pressures, compliances, and the location of all measurement equipment, as well as the rationale for the test set-up, shall be provided. In both a volume displacement pump and a rotary pump VAD system, this testing includes the characterization of all time dependent parameters as they operate with (or as a replacement for) the native heart in a pulsatile environment. In this way the simulated performance effects of the system on the patient and the patient on the system can be understood.ANSI AAMI ISO 14708-5-2010 pdf download
