AAMI MP80601 249 2020
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ANSI/AAMI MP80601-249:2020 (IEC 80601-2-49:2020, MOD), Medical electrical equipment-Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 | 47 |
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of MULTIFUNCTION PATIENT MONITORS. It amends and supplements IEC 60601-1:2005 and IEC 606011:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI MP80601-2-49:2020 (IEC 80601-2-49:2020, MOD) Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| 2 | Blank Page |
| 3 | Title Page |
| 4 | AAMI Standard |
| 5 | Contents Page |
| 7 | Committee representation |
| 8 | Background of ANSI/AAMI adoption of IEC 80601-2-49:2018 with deviations |
| 9 | U.S. Deviations to IEC 80601-2-49:2018 |
| 10 | Foreword |
| 13 | Introduction |
| 15 | 201.1 Scope, object and related standards 201.1.1 * Scope |
| 16 | 201.1.2 Object 201.1.3 Collateral standards 201.1.4 Particular standards |
| 17 | 201.2 Normative references |
| 18 | 201.3 Terms and definitions 201.4 General requirements 201.4.3 Essential performance 201.4.3.101 Additional essential performance requirements |
| 19 | Table 201.101 – ESSENTIAL PERFORMANCE requirements 201.4.5 * Alternative risk control measures or test methods for me equipment or me systems 201.5 General requirements for testing me equipment 201.5.4 Other conditions 201.6 Classification of me equipment and me systems |
| 20 | 201.6.2 * Protection against electric shock 201.6. 6 Mode of operation 201.7 Me equipment identification, marking and documents 201.7.2 Marking on the outside of me equipment or me equipment parts 201.7.2.101 Connectors for applied parts 201.7.9.2.2 Warning and safety notices 201.7.9.2.9 Operating instructions 201.7.9.2.9.101 Additional instructions for use |
| 21 | 201.8 Protection against electrical hazards from me equipment 201.8.3 Classification of applied parts 201.8.5.2.3 * Patient leads or patient cables |
| 22 | Figure 201.101 – MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a single PHYSIOLOGICAL MONITORING UNIT |
| 23 | 201.8.5.5.1 * Defibrillation protection 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 201.11.6.5 * Ingress of water or particulate matter into me equipment and me systems |
| 24 | 201.11. 8 * Interruption of the power supply / supply mains to me equipment 201.11.8.101 Protection against depletion of the internal electrical power source |
| 25 | 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12. 3 Alarm systems 201.13 Hazardous situations and fault conditions for me equipment 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.15.1 Arrangements of controls and indicators of ME EQUIPMENT 201.15.101 Display of patient data 201.15.102 Units of measurement 201.15.4.4 Indicators |
| 26 | 201.15.4.4.101 Indicator of operation from the internal electrical power source and the status of the internal electrical power source 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic disturbances – Requirements and tests 202.7 Electromagnetic emissions requirements for me equipment and me systems 202.7.1 Protection of radio services and other equipment 202.7.1.101 * Emissions test setup |
| 27 | Figure 202.101 – Test layout for conducted and radiated EMISSIONS and IMMUNITY test(see 202.7.1.101 and 202.8.101) 202.8.1 General |
| 28 | 202.8.101 * Immunity test setup 202.8.102 * Disturbances from hf surgical equipment |
| 29 | Figure 202.102 – Test circuit for HF SURGICAL EQUIPMENT protection measurement according to 202.8.102 with PATIENT CONNECTIONS |
| 30 | Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT protection measurement according to 202.8.102 |
| 31 | Figure 202.104 – Test circuit for HF SURGICAL EQUIPMENT protection measurement according to 202.8.102 with non-conductive APPLIED PART 206 Usability 206.101 Primary operating functions |
| 32 | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.6.1.2 * Determination of alarm conditions and assignment of priority 208.6.3.2 Visual alarm signals 208.6.3.2.101 * Indication of validity of measured values 208.6.5 Alarm presets |
| 33 | 208.6.8 Alarm signal inactivation states 208.6.8.1 * General 208.6.10 * Non-latching and latching alarm signals 208.6.10.101 * Non-latching alarm signals for technical alarm conditions |
| 34 | 208.6.11.1 Existence of distributed alarm system 208.6.12 alarm system logging |
| 35 | Annexes |
| 36 | Annex AA (informative) Particular guidance and rationale AA.1 Rationale and background AA.2 Rationale for particular clauses and subclauses |
| 37 | Figure AA.1 – Example of a pre-configured MULTIFUNCTION PATIENT MONITOR Figure AA.2 – Example of a modular MULTIFUNCTION PATIENT MONITOR |
| 38 | Figure AA.3 – Example of a MULTIFUNCTION PATIENT MONITOR connected to a central station Figure AA.4 – Example of a MULTIFUNCTION PATIENT MONITOR integrated into a ventilator |
| 40 | Figure AA.5 – Single PATIENT circuit with multiple PHYSIOLOGICAL MONITORING UNITS and PATIENT cables |
| 44 | Bibliography |
| 45 | Index of defined terms used in this particular standard |
