| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 13<\/td>\n | 201.1 Scope, object and related standards 201.1. 1 *\u00a0Scope 201.1. 2 Object <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 201.1. 3 Collateral standards 201.1. 4 Particular standards <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 201.2 Normative references <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 201.4 General requirements 201.4. 3 Essential performance 201.4. 101 *\u00a0Additional requirements for essential performance <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 201.4. 102 Additional requirements for acceptance criteria 201.4. 103 Additional requirements for pulse oximeter equipment, parts and accessories 201.5 General requirements for testing of me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 201.6 Classification of me\u00a0equipment and me\u00a0systems 201.7 Me\u00a0equipment identification, marking and documents 201.7. 2.3 Consult accompanying documents 201.7. 2.9 IP classification 201.7. 2.101 Additional requirements for marking on the outside of me\u00a0equipment or me equipment parts <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 201.7. 2.4.101 Additional requirements for accessories 201.7. 2.13.101 Additional requirements for physiological effects 201.7. 2.17.101 Additional requirements for protective packaging <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 201.7. 4.3 Unit of measure 201.7. 9.1 Additional general requirements 201.7. 9.2.1.101 Additional general requirements <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 201.7. 9.2.2.101 Additional requirements for warnings and safety notices 201.7. 9.2.8.101 Additional requirements for start-up procedure 201.7. 9.2.9.101 Additional requirements for operating instructions <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 201.7. 9.2.14.101 Additional requirements for accessories, supplementary equipment, used material 201.7. 9.3.1.101 *\u00a0Additional general requirements <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 201.8 Protection against electrical hazards from me\u00a0equipment 201.8. 3.101 Additional requirements for classification of applied parts 201.9 Protection against mechanical hazards of me equipment and me systems 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 201.11. 6.5.101 *\u00a0Additional requirements for ingress of water or particulate matter into me\u00a0equipment or me\u00a0system 201.11. 8.101 Additional requirements for interruption of the power supply\/supply\u00a0mains to me\u00a0equipment 201.11. 8.101.1 Supply failure technical alarm condition 201.11. 8.101.2 Settings and data storage following short interruptions or automatic switchover <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 201.11. 8.101.3 Operation following long interruptions 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12. 1 Accuracy of controls and instruments 201.12. 1.101 *\u00a0SpO2 accuracy of pulse oximeter equipment 201.12. 1.101.1 *\u00a0Specification <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 201.12. 1.101.2 Determination of SpO2 accuracy 201.12. 1.101.2.1 *\u00a0Data collection 201.12. 1.101.2.2 *\u00a0Data analysis <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 201.12. 1.101.2.3 Characteristics of the clinical study population 201.12. 1.102 Accuracy under conditions of motion 201.12. 1.103 Accuracy under conditions of low perfusion 201.12. 1.104 Pulse rate accuracy 201.12. 4 Protection against hazardous output 201.12. 4.101 *\u00a0Data update period <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 201.12. 4.102 *\u00a0Signal inadequacy 201.13 Hazardous situations and fault conditions 201.13. 101 Detection of pulse oximeter probe faults and probe cable extender faults 201.14 Programmable electrical medical systems (pems) <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 201.15 Construction of me\u00a0equipment 201.15. 3.5.101 *\u00a0Additional requirements for rough handling 201.15. 3.5.101.1 *\u00a0Shock and vibration <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 201.15. 3.5.101.2 *\u00a0Shock and vibration for professional transport <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 201.15. 101 Mode of operation 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 201.101 *\u00a0Pulse oximeter probes and probe cable extenders 201.101. 1 General <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 201.101. 2 Labelling 201.102 Saturation pulse information signal 201.103 Signal input\/output part 201.103. 1 General 201.103. 2 Connection to electronic health record <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 201.103. 3 Connection to a distributed alarm system 201.103. 4 Connection for remote control 202 Medical electrical equipment\u00a0\u2014 Part 1-2: General requirements for safety\u00a0\u2014 Collateral standard: Electromagnetic compatibility\u00a0\u2014 Requirements and tests 202.6.2.1.1 Immunity test levels 202.6.2.1.7 Patient simulation <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 202.6.2.1.10 *\u00a0Requirements 202.6.2.3 *\u00a0Radiated RF electromagnetic fields 208 Medical electrical equipment\u00a0\u2014 Part 1-8: General requirements for safety\u00a0\u2014 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.6.1.2.101 *\u00a0Additional requirements for alarm condition priority <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 208.6.5.4.101 *\u00a0Additional requirements for default alarm preset 208.6.8.5.101 Additional requirements for alarm signal inactivation states, indication and access <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for basic safety and essential performance of pulse oximeter equipment<\/b><\/p>\n |