Page 9 - Safety Risk Management for Medical Devices

viii Contents

8.4 Use Failures 36
8.5 Environmental Factors 37
8.6 Design Means to Control Usability Risks 38
8.7 Task Analysis 38
8.8 Usability and Risk 39

9. Biocompatibility and Risk Management 41

10. The BXM Method 45
10.1 System Decomposition 45
10.2 Integration 46
10.3 Quantitative Risk Estimation 47

11. Risk Management Process 49
11.1 Management Responsibilities 52
11.2 Risk Management File 53
11.3 Risk Management Plan 53
11.4 Hazard Identification 60
11.5 Clinical Hazards List 61
11.6 Harms Assessment List 62

12. Risk Analysis Techniques 67
12.1 Fault Tree Analysis 67
12.2 Mind Map Analysis 75
12.3 Preliminary Hazard Analysis 77
12.4 Failure Modes and Effects Analysis 80
12.5 FMEA in the Context of Risk Management 90
12.6 Design Failure Modes and Effects Analysis 92
12.7 Process Failure Modes and Effects Analysis 103
12.8 Use/Misuse Failure Modes and Effects Analysis 109
12.9 P-Diagram 117
12.10 Comparison of FTA, FMEA 119

13. Safety Versus Reliability 121

14. Influence of Security on Safety 123

15. Software Risk Management 127
15.1 Software Risk Analysis 130
15.2 Software Failure Modes and Effects Analysis (SFMEA) 132
15.3 Software Safety Classification 137