BS EN ISO 80601-2-61:2011
$215.11
Medical electrical equipment – Particular requirements for basic safety and essential performance of pulse oximeter equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2011 | 98 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 13 | 201.1 Scope, object and related standards 201.1. 1 * Scope 201.1. 2 Object |
| 14 | 201.1. 3 Collateral standards 201.1. 4 Particular standards |
| 15 | 201.2 Normative references |
| 16 | Terms and definitions |
| 20 | 201.4 General requirements 201.4. 3 Essential performance 201.4. 101 * Additional requirements for essential performance |
| 21 | 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 equipment |
| 22 | 201.6 Classification of me equipment and me systems 201.7 Me equipment 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 equipment or me equipment parts |
| 23 | 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 |
| 24 | 201.7. 4.3 Unit of measure 201.7. 9.1 Additional general requirements 201.7. 9.2.1.101 Additional general requirements |
| 25 | 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 |
| 26 | 201.7. 9.2.14.101 Additional requirements for accessories, supplementary equipment, used material 201.7. 9.3.1.101 * Additional general requirements |
| 27 | 201.8 Protection against electrical hazards from me equipment 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 |
| 28 | 201.11. 6.5.101 * Additional requirements for ingress of water or particulate matter into me equipment or me system 201.11. 8.101 Additional requirements for interruption of the power supply/supply mains to me equipment 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 |
| 29 | 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 * SpO2 accuracy of pulse oximeter equipment 201.12. 1.101.1 * Specification |
| 30 | 201.12. 1.101.2 Determination of SpO2 accuracy 201.12. 1.101.2.1 * Data collection 201.12. 1.101.2.2 * Data analysis |
| 31 | 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 * Data update period |
| 32 | 201.12. 4.102 * Signal 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) |
| 33 | 201.15 Construction of me equipment 201.15. 3.5.101 * Additional requirements for rough handling 201.15. 3.5.101.1 * Shock and vibration |
| 34 | 201.15. 3.5.101.2 * Shock and vibration for professional transport |
| 35 | 201.15. 101 Mode of operation 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 201.101 * Pulse oximeter probes and probe cable extenders 201.101. 1 General |
| 36 | 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 |
| 37 | 201.103. 3 Connection to a distributed alarm system 201.103. 4 Connection for remote control 202 Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests 202.6.2.1.1 Immunity test levels 202.6.2.1.7 Patient simulation |
| 38 | 202.6.2.1.10 * Requirements 202.6.2.3 * Radiated RF electromagnetic fields 208 Medical electrical equipment — Part 1-8: General requirements for safety — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.6.1.2.101 * Additional requirements for alarm condition priority |
| 39 | 208.6.5.4.101 * Additional requirements for default alarm preset 208.6.8.5.101 Additional requirements for alarm signal inactivation states, indication and access |
