Page 418 - Safety Risk Management for Medical Devices

Index 397

UMFMEA Lasers, 221
detectability ratings definitions, 116t Law of identity, 177
occurrence ratings definitions, 115t Legacy devices, risk management for, 209
severity ratings definitions, 115t Legacy software, 131, 141 142, 144 146
Intentional—Malicious, 123 Legal and regulatory requirements, 4 5
Intentional—Misuse, 123 European Union, 4 5
Interfaces, 79, 94f MDD/AIMDD and transition to EU MDR, 5
Intermediate architectural level, 94 United States, 4
International product safety standards, 174 Leverage verification, 185
Intravenous infusion pumps (IV infusion pumps), Lifecycle relevance of risk management, 224 225
111 Lipitor, 16
Investigational Device Exemptions (IDEs), 188 Local Effect, 96, 133
Investigational medical device, 204 Logic gates, 67, 69
Investigator’s brochure, 204 Lognormal distribution, 178
ISO 10993 standard, 42, 214 Lower level components, 151
ISO 10993 1 standard, 41, 214 “Lower” events, 69
interaction with, 214 216
ISO 14155 standard, 203, 205 206 M
interaction with, 217 218
Magnitude of benefit, 188
ISO 14971 standard, 18 20, 19f, 23, 24f, 39,
Maintenance function, 79
41 42, 49, 51 55, 157, 160f, 163 164,
Malice, 32 34, 111, 124
169, 171 172, 187, 193, 201, 206, 209,
Malicious actions, 124
214, 217, 221, 235
Management responsibilities, 52
history and origins, 23 24
Manufacturers, 2
interaction, 213 214
Manufacturing process, 165
with IEC 60601 1
Mapping of risk management terminology,
with IEC 62366, 216 217
205 206
with ISO 10993 1, 214 216
Mass interface, 94
with ISO 14155, 217 218
MAUDE, 26, 194
severity based on, 206t MDD. See Medical Device Directive (MDD)
ISO designation, 23 24 ME equipment. See Medical electrical equipment
ISO/TC 210 WG4, 23 24 (ME equipment)
Issue detection, 220
MEDDEV 2.7/1, 191 192
IV infusion pumps. See Intravenous infusion
Medical device companies, challenges of, 1
pumps (IV infusion pumps)
Medical Device Directive
(MDD), 4 5, 188, 196
J Medical devices, 4, 23, 31, 40 41, 60, 123,
JWG1 IEC/SC 62A, 23 24 163 164, 167, 172, 186, 188, 190, 209,
211, 213 214
K risk analysis, 61
risk management, 230
Keystroke debouncing, 38
security, 123
Knowledge-based failure, 37
software, 131
Medical electrical equipment (ME equipment),
L 213
Labeling, 167 Medical technology
Lagging indicator, 219 (MedTech), 3
Lapse, 32 34 Mental models, 17