Page 417 - Safety Risk Management for Medical Devices

396 Index

Ground rules (Continued) Human Factors and Usability Engineering (HFE),
in FEMA, 84 85 31 32
judicious in modeling secondary faults, 75 Human psychology, 229
mark low-likelihood faults as basic events, 75 Hypoglycemia, 199
no gate-to-gate connections, 75
write faults as faults, 75 I
Ideal function, 119
H IDEs. See Investigational Device Exemptions
HAL. See Harms Assessment List (HAL) (IDEs)
HAR. See Hazard Analysis Report (HAR) IEC 60601 1 standard, 23 24, 186, 211
Hardware risk-analysis, 130 interaction with, 213 214
Harm severity, 125, 125f IEC 60601 1-8 standard, 186
Harm(s), 2, 11, 20, 159 IEC 62304 standard, 127, 129, 201
column, 173 IEC 62366 standard, 31, 61
of electrocution, 63 interaction with, 216 217
of interest, 64 IEC 62366 1 standard, 186
severity, 139t, 160, 206 IEC 62366 1:2015 standard, 31
severity, type, likelihood, and duration, 189 IEC 62366 2 standard, 216 217
Harmonized product safety standard, 56 IEC TR 62366 2:2016 standard, 31
Harmonized standards, 24 IFU, 184 185
Harms Assessment List (HAL), 53, 62 66, 62t, Immediate event, 70 71
78, 138, 173, 236 Incomplete sealing, 107
creation, 63 66 Incorrect action, 111
using expert opinion, 65 66, 65f Incorrect cognition, 111
using published data, 64 Incorrect perception, 111
of Vivio, 281 285 Incredulity, 233
Hazard analysis process, 11 12, 90 Indenture level, 81
Hazard Analysis Report (HAR), 51, 78 Indirect Causes, 133
of Vivio, 360 368 Indirect Hazard, 61
Hazard(s), 41, 60, 123, 128, 195, 201 202, 214 Inductive analysis, 80
hazard-related use scenario, 32 34, 39 Information for safety, 144, 173
identification, 26, 60 61, 215 as risk control measure, 166 168
taxonomy, 26t criteria for, 166 168
probability, 126 Information sources, 194
software chain of events to system, 130f Infusion pump, 92
software contribution to, 128 Inherent safety by design, 144
theory, 13, 13f Initiating event, 84
Hazardous Situation, 19 20, 40, 79 81, Injury, 230
138 139, 172, 199, 227 Input signals, 118
Health Hazard Assessment (HHA), 196 Integral systems, 13, 91, 91f
HFE. See Human Factors and Usability Integration, 46 47
Engineering (HFE) Intended use, 112 113
HHA. See Health Hazard Assessment (HHA) RPN table, 117t
Hierarchical multilevel FMEA, 82 83, 82f, 133, UMFMEA workflow, 113 117
151 154 analyzing, 113 117
High granularity scale, 119 identify primary and secondary functions,
“Higher” event, 69 113
Historical projects, comparison with, 219 scope setting, 113