Page 421 - Safety Risk Management for Medical Devices

400 Index

Risk (Continued) PFMEA, 103 108
acceptability criteria, 54 60, 80, 172 PHA, 77 80
application, 171 173 UMFMEA, 109 117
benefits, 221 use specification versus intended use,
computation, 19 21, 173 112 113
contributors to, 17 18 and usability engineering, 31
definitions, 16 design means to control usability risks, 38
documentation requirements, 208 distinctions, 34
estimation, 26, 42, 124, 215 environmental factors, 37 38
5-scale risk, 20f task analysis, 38
phase, 49 51 usability and risk, 39 40
pre-/postrisk, 162 use failures, 36 37
qualitative method, 157 user-device interaction model, 34 36
quantitative method, 159 161 Risk Assessment and Control Table (RACT), 39,
semiquantitative method, 157 159 51, 78 79, 169, 171, 177, 201 202, 212,
evaluation, 173 236, 265, 340 359
application of risk acceptance criteria, individual and overall residual risks, 174
171 173 workflow, 172 173
for qualitative method, 173 capture end-effects with safety impact, 172
for quantitative method, 174 compute risks, 173
for semiquantitative method, 173 174 examine clinical hazards list, 172
of harm, 101 populate harm column, 173
perception, 18 19 populate hazardous situations column, 172
profile, 59 populate initial cause and sequence of events
risk-based sample size selection, 176 columns, 172
tolerance, 190 populate P1 column, 173
types of, 17, 206 populate P2 columns, 173
and usability, 39 40 populate risk controls columns, 173
data gathering, 40 revisit PHA, 172
risk reduction and compliance with IEC risk evaluation, 173
62366 process, 40 template, 261 263
Risk analysis, 11 12, 25 26, 49, 172, 201 202, Risk control measure, 39, 43, 165 166, 197
207, 210 information for safety, 166 168
hazard identification, 26 criteria for information for safety, 166 168
integration Risk controls, 26, 51, 124, 142 144, 163,
hierarchical multilevel FMEA, 151 154 167 169, 171, 176, 197, 207, 214 216
supplier input into risk management, columns, 173
154 155 completeness, 169
risk estimation, 26 information for safety as risk control measure,
techniques 166 168
comparison of FTA, FMEA, 119 120 criteria for information for safety, 166 168
DFMEA, 92 102 option
FEMA, 80 90 analysis, 164 165, 173
FMEA in context of risk management, distinctions of, 165
90 92 and safety requirements, 169
FTA, 67 75, 69f sample risk controls, 168 169
mind map analysis, 75 77, 76f single-fault-safe design, 163 164
P-diagram, 117 119, 118f verification, 27