Page 416 - Safety Risk Management for Medical Devices

Index 395

EN ISO 13485 standard, 52, 55 on merits of RPN for criticality ranking,
EN ISO 14971 standard, 4, 102, 108, 166 85 86
EN ISO 14971:2012 standard, 24 ownership, 87 88
End Effect, 83, 96, 103f weaknesses, 87
column, 133 Failure(s), 68, 81
of sensor FMEA, 102 theory, 83 84, 83f
Energy interface, 94 Fault tree (FTs), 67, 69
Engine, 151 152 Fault Tree Analysis (FTA), 49 51, 67 75, 69f
subsystems, 152f comparison, 119 120
Environmental factors, 37 38, 71 ground rules, 74 75
Error(s), 84 methodology, 73 74
states, 119 symbols, 71 72, 72f
Essential design outputs (EDOs), 222 alternate FTA, 73f
identification, 222 224, 223f theory, 69 71
Essential performance, 211 212, 214 CCF, 71
identifying essential performance, 211 212 immediate, necessary, and sufficient, 70 71
EUDAMED, 26, 194 primary, secondary, and command Faults, 70
EUMDR. See European Medical Device state of component state of system, 71
Regulation (EUMDR) Fault(s), 68, 71, 81
European Medical Device Regulation (EUMDR), condition, 163 164
3 5 low-likelihood, 75
transition to, 5 write faults as, 75
European Union, legal and regulatory FDA. See Finished design output (FDA)
requirements in, 4 5 Field corrective actions, 6
European Union directive 93/42/EEC. Finer method, 86
See Medical Device Directive (MDD) Finished design output (FDA), 31 32, 124 125,
Event, 68 146, 188, 193, 222
event-chain model, 18 Flu virus, 20
populating initial cause and sequence of events FMEA. See Failure Modes and Effects Analysis
columns, 172 (FMEA)
“Existing Mitigations” Font size, 38
columns, 134 Formal usability engineering task analysis, 113
Expert opinion, 65 66, 65f Formative Evaluation, 32 34
Exploitability, 125, 125f Formative Study. See Formative Evaluation
Formative testing, 216
F FTA. See Fault Tree Analysis (FTA)
FTs. See Fault tree (FTs)
Failure mode
Fuel system, 46
column, 132 133
Functional Failure Modes, 95
interaction, 96
Failure Modes and Effects Analysis (FMEA), 39,
46 47, 49 51, 60, 68, 80 90, 132, 151, G
151f, 161, 172, 223 225, 236, 265 Galvanic process, 215
benefits, 86 87 Gamma radiation, 221
facilitation, 82 device, 121
failure theory, 83 84, 83f Geometric properties, 42
ground rules, 84 85 Graphical user interfaces, 167
hierarchical multilevel, 82 83, 82f Ground rules, 74 75
making your way through, 88 90 don’t model passive components, 75