Page 10 - Safety Risk Management for Medical Devices
P. 10
Contents ix
15.4 The BXM Method for Software Risk Analysis 141
15.5 Risk Management File Additions 142
15.6 Risk Controls 142
15.7 Legacy Software 144
15.8 Software of Unknown Provenance 146
15.9 Software Maintenance and Risk Management 146
15.10 Software Reliability Versus Software Safety 147
16. Integration of Risk Analysis 151
16.1 Hierarchical Multilevel Failure Modes and Effects Analysis 151
16.2 Integration of Supplier Input Into Risk Management 154
17. Risk Estimation 157
17.1 Qualitative Method 157
17.2 Semiquantitative Method 157
17.3 Quantitative Method 159
17.4 Pre-/Post-Risk 162
18. Risk Controls 163
18.1 Single-Fault-Safe Design 163
18.2 Risk Control Option Analysis 164
18.3 Distinctions of Risk Control Options 165
18.4 Information for Safety as a Risk Control Measure 166
18.5 Sample Risk Controls 168
18.6 Risk Controls and Safety Requirements 169
18.7 Completeness of Risk Controls 169
19. Risk Evaluation 171
19.1 Application of Risk Acceptance Criteria 171
19.2 Risk Evaluation for Qualitative Method 173
19.3 Risk Evaluation for Semiquantitative Method 173
19.4 Risk Evaluation for Quantitative Method 174
20. Risk Assessment and Control Table 175
20.1 Risk Assessment and Control Table Workflow 176
20.2 Individual and Overall Residual Risks 178
21. On Testing 179
21.1 Types of Testing 179
21.2 Risk-Based Sample Size Selection 180
21.3 Attribute Testing 180
21.4 Variable Testing 182
