Page 424 - Safety Risk Management for Medical Devices

Index 403

software Testing, 175, 183
maintenance and risk management, 146 147 attribute, 176 177
risk analysis, 130 132 risk-based sample size selection, 176
safety classification, 137 141 types, 175 176
of unknown provenance, 146 variable, 178
Software Safety class, 139t Therapy
SOPs, 29 availability of alternative, 190
SOTA. See State-of-the art (SOTA) therapy-advisory System, 54
SOUP. See Software of Unknown Pedigree Thinking errors, 233
(SOUP); Software of Unknown “Top Management”, 52
Provenance (SOUP) Top-down analyses, 53
“Source” column, 132 Top-down System analyses, 128
SS fault. See State of system fault (SS fault) Toxic metal, 80
Stakeholder concerns, 55, 172 173 Toxicological risks, 43
Standard(s), 23, 38, 214 Traceability, 201 202, 201f, 236
Standard IEC 62304, 132 analysis report, 202
Standardized CHL, 60 Trending of data, 195
State of component fault (SC fault), 71, 73
State of system fault (SS fault), 71, 73
State-of-the art (SOTA), 54 56, 172, 190 191 U
risk reduction end-point logic with, 57f UI. See User Interface (UI)
risk reduction end-point logic without, 58f UMFMEA. See Use-Misuse Failure Modes and
Summative Evaluation, 32 34 Effects Analysis (UMFMEA)
Summative testing, 185 186, 216 Unavailability, 123
Super-focus, 233 Unintentional—use error, 123
Surveillance, 194 United States, legal and regulatory requirements
System DFMEA. See Design Failure Modes and in, 4
Effects Analysis (DFMEA) Usability, 32 34
System(s), 118, 132 engineering and risk analysis, 31
components, 151 design means to control usability
decomposition, 45 46, 46f risks, 38
design failure modes and effects analysis, 172 distinctions, 34
hazards, 26 environmental factors, 37 38
identification, 78 80 key terms, 32 33
requirements, 168 169 task analysis, 38
specifications for Vivio, 266 267 usability and risk, 39 40
systematic investigation, 204 Use Failures, 36 37
types, 13 14 user-device interaction model, 34 36
and risk, 39 40
T data gathering, 40
3T MRI environment, 176 risk reduction and compliance with IEC
Task, 32 34 62366 process, 40
analysis, 38 testing, 185 186
Templates, 239 Usability Engineering, 217
DFMEA, 239 243 standard, 216
PFMEA, 250 254 Use failure, 32 34, 36 37
RACT, 261 263 risks, 40
SFMEA, 245 249 Use specification, 112 113
UMFMEA, 255 259 RPN table, 117t