Method of fault injection for medical device based on ISO 26262

Today, Many industries are studying methods that enhance and measure dependability. Dependability measurement methods use fault injection to monitor the state of a system. A fault/error that occurs in an unexpected situation, giving rise to an extreme status, can be inspected. To obtain high Automotive Safety Integrity Level (ASIL) in automotive safety standard (ISO 26262), any system must be tested using fault injection technique. NASA standard (8719.13B) also recommends the fault injection test. In contrast, the medical device safety standard (ISO 14971) does not mention the fault injection test. In this paper, we compare the difference between two standards and introduce a method of fault injection in medical device.