Page 173 - Safety Risk Management for Medical Devices

152 Safety Risk Management for Medical Devices

This concept is elucidated below in an example of an automobile System. An
automobile is comprised of several subsystems (see Fig. 16.2). For this example, let’s
consider the propulsion system—the Engine.
In the illustration in Fig. 16.2 the Engine is a black box. But the Engine itself is
comprised of many other subsystems. In Fig. 16.3 a number of Engine subsystems are
illustrated. Let’s consider the cooling system—the Water Pump.
In the illustration in Fig. 16.3 the Water Pump is a black box. But the Water
Pump itself is comprised of many other parts. In Fig. 16.4 the Water Pump is decom-
posed to its constituent parts. We will not further decompose the Water Pump parts.

Figure 16.2 Automobile subsystems.

Figure 16.3 Engine subsystems.