AAMI 60601 2 4 2010 RL
$162.84
ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version) – Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
| Published By | Publication Date | Number of Pages |
| AAMI | 2010 | 84 |
This consolidated version includes the amendment which updates references and clarifies the scope as well as provides additional information for AEDs, defibrillator electrodes, audible warnings and cables. (Red-line)
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 60601-2-4:2010/A1:2018; Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 (Redline Version) |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Committee representation |
| 8 | Background of ANSI/AAMI adoption of IEC 60601-2-4:2010/A1:2018 |
| 9 | Foreword |
| 13 | 201.1 Scope, object and related standards 201.1. 1 * Scope |
| 14 | 201.1. 2 Object 201.1. 3 Collateral standards 201.1. 4 Particular standards |
| 15 | 201.2 Normative references 201.3 Terms and definitions |
| 18 | 201.4 General requirements 201.4. 2 Risk management process for me equipment or me systems 201.4. 2.101 * Additional risk management requirements 201.4. 3 Essential performance 201.4. 3.101 * Additional essential performance requirements Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements 201.5 General requirements for testing of me equipment 201.5.3 * Ambient temperature, humidity, atmospheric pressure |
| 19 | 201.5.4 Other conditions 201.5.8 Sequence of tests 201.6 Classification of me equipment and me systems 201.6.2 * Protection against electric shock 201.7 Me equipment identification, marking and documents 201.7.2 Marking on the outside of me equipment or me equipment parts 201.7.2.7 * Electrical input power from the supply mains 201.7.2.101 * Concise operating instructions |
| 20 | 201.7.2.102 * Internally powered me equipment 201.7.2.103 Disposable defibrillator electrodes 201.7.4 Marking of controls and instruments 201.7.4.101 * Selected energy control 201.7.9.2.4 * Electrical power source |
| 21 | 201.7.9.2.101 * Supplementary instructions for use |
| 22 | 201.7.9.3 Technical description 201.7.9.3.101 * Essential performance data for defibrillation 201.7.9.3.102 * Essential performance data of any synchronizer |
| 23 | 201.7.9.3.103 * Essential performance data of the rhythm recognition detector 201.8 Protection against electrical hazards from me equipment 201.8.3 * Classification of applied parts 201.8.5.5.1 * Defibrillation protection |
| 24 | 201.8.5.5.101 * Isolation of defibrillator electrodes |
| 25 | Figure 201.101 – Dynamic test for limitation of energyfrom different parts of the ME EQUIPMENT 201.8.5.5.102 * Applied parts not being defibrillator electrodes 201.8.5.5.103 Charging of the energy storage device 201.8.7 * Leakage currents and patient auxiliary currents 201.8.7.1 * General requirements |
| 26 | 201.8.7.3 * Allowable values 201.8.7.4.7 Measurement of the patient leakage current 201.8.8.3 * Dielectric strength |
| 29 | Figure 201.102 – Allowed current versus applied test voltage 201.8.9.1 Values 201.8.9.1.5 * me equipment rated for high altitudes 201.8.9.1.101 * defibrillator electrodes, high-voltage circuits and cables |
| 30 | 201.9 Protection against mecahnical 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 201.11.1.3 Measurements |
| 31 | 201.11.6.3 * Spillage on me equipment and me systems 201.11.6.5 Ingress of water or particulate matter into me equipment and me systems |
| 32 | 201.11.6.7 * Sterilization of me equipment and me systems 201.12 * Accuracy of controls and instruments and protection against hazardous outputs 201.12.1 * Accuracy of controls and instruments 201.12.2 Usability 201.12.2.101 * ELECTRODE energizing controls |
| 33 | 201.12.2.102 Display of signals 201.12.3 Alarm systems 201.12.3.101 * Audible warnings prior to energy delivery 201.12.4 Protection against hazardous output 201.12.4.1 * Intentional exceeding of safety limits 201.12.4.101 * Output voltage 201.12.4.102 * Unintentional energy |
| 34 | 201.12.4.103 * Internal discharge circuit 201.13 Hazardous situations and fault conditions 201.13.1.3 * Exceeding leakage current or voltage limits 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.15.4 * Me equipment components and general assembly 201.15.4.3 Batteries 201.15.4.3.101 * Non-rechargeable Battery replacement |
| 35 | 201.15.4.3.102 Battery charging indicator 201.15.4.3.103 * Rechargeable battery |
| 36 | 201.15.4.101 * Defibrillator electrodes and their cables |
| 38 | Figure 201.103 – Examples of cord anchorages that require testing |
| 39 | Figure 201.104 – Test apparatus for flexible cords and their anchorages 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 201.101 * Charging time 201.101.1 Requirements for frequent use, manual defibrillators |
| 40 | 201.101.2 Requirements for infrequent use, manual defibrillators |
| 41 | 201.101.3 * Requirements for frequent use, automated external defibrillators 201.101.4 * Requirements for infrequent use, automated external defibrillators |
| 42 | 201.102 Internal electrical power source 201.102.1 General 201.102.2 * Requirements for manual defibrillators 201.102.3 * Requirements for automated external defibrillators (AED) 201.102.3.1 Frequent use AED |
| 43 | 201.102.3.2 Infrequent use AED |
| 44 | 201.103 * Endurance 201.104 * Synchronizer |
| 45 | 201.105 * Recovery of the monitor and/or ECG input after defibrillation 201.105.1 ECG signal derived via defibrillator electrodes |
| 46 | Figure 201.105 – Arrangement for test of recovery after defibrillation 201.105.2 ECG signal derived via any separate monitoring electrodes |
| 47 | Figure 201.106 – Arrangement of monitoring electrodes on sponge Figure 201.107 – Arrangement for recovery test after defibrillation 201.105.3 ECG signal derived via non-reusable defibrillator electrodes |
| 48 | 201.106 * Disturbance to the monitor from charging or internal discharging |
| 49 | Figure 201.108 – Arrangement for test of disturbance from chargingand internal discharging 201.107 * Requirements for rhythm recognition detector Table 201.102 – RHYTHM RECOGNITION DETECTOR categories |
| 50 | 201.108 Defibrillator electrodes 201.108.1 * Defibrillator electrodes for monitoring and defibrillation, and (optionally) pacing 201.108.1.1 * AC small signal impedance 201.108.1.2 * AC large signal impedance |
| 51 | 201.108.1.3 * Combined offset instability and internal noise 201.108.1.4 * Defibrillation recovery 201.108.1.5 * Biological response 201.108.1.6 * DC offset voltage 201.108.1.7 * Electrode active area 201.108.1.8 * Electrode adhesion and contact to patient |
| 52 | 201.108.1.9 * Packaging and shelf life 201.108.1.10 * Universal-function electrodes 201.108.1.11 * Cable length 201.109 * External pacing (U.S.) 201.109.1 Pacing mode activation 201.109.2 Pacing delivery |
| 53 | 201.109.2.1 Separate pacing pathway 201.109.2.2 Combined pathway 201.109.3.1 Pace pulse duration accuracy 201.109.3.2 Pace pulse duration stability |
| 54 | 201.109.4 Pacing pulse current 201.109.4.1 Pacing pulse current accuracy 201.109.4.2 Pacing pulse current stability 201.109.5 Pacing rate 201.109.5.1 Pacing rate accuracy |
| 55 | 201.109.5.2 Pacing rate stability 201.109.6 Pacing protocol 201.109.7 Demand pacing |
| 56 | 201.109.8 Pacer lead-off indication |
| 57 | Figure 201.110 – Test circuit for DEFIBRILLATOR overload test of pacing output circuitry 202 * Electromagnetic compatibility – Requirements and tests 202.6.1 Emissions 202.6.1.1 Protection of radio services 202.6.1.1.1 Requirements 202.6.2.2 Electrostatic discharge (ESD) 202.6.2.2.1 Requirements |
| 58 | 202.6.2.2.2 Tests 202.6.2.3 Radiated RF electromagnetic fields 202.6.2.3.1 Requirements 202.6.2.3.2 * Tests 202.6.2.4 Electrical fast transients and bursts 202.6.2.4.1 Requirements 202.6.2.4.2 Tests |
| 59 | 202.6.2.5 Surges 202.6.2.5.1 Requirements 202.6.2.6 Conducted disturbances, induced by RF fields 202.6.2.6.1 Requirements 202.6.2.6.2 Tests 202.6.2.8.1 Power frequency magnetic fields 202.6.2.8.1.1 Requirements 202.6.2.8.1.2 Test Annexes |
| 60 | Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems 201.C.1 Marking on the outside of me equipment, me systems or their parts Table 201.C.101 – Marking on the outside of a CARDIAC DEFIBRILLATOR or its parts 201.C.3 Marking of controls and instruments Table 201.C.102 – Marking of controls and instruments of a CARDIAC DEFIBRILLATOR 201.C.4 Accompanying documents, general |
| 61 | Table 201.C.103 – ACCOMPANYING DOCUMENTS, general 201.C.5 Accompanying documents, Instructions for use Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use 201.C.6 Accompanying documents, technical description Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description |
| 62 | Annex AA (informative) Particular guidance and rationale AA.1 General guidance AA.2 Rationale for particular clauses and subclauses |
| 63 | Subclause 201.4.2.101 – Additional risk management requirements Subclause 201.4.3.101 – Additional essential performance requirements |
| 75 | Figure AA.1 – Simulated PATIENT load |
| 77 | Annex BB (informative) Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010 Table BB.1 – Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010 |
| 82 | Bibliography |
| 83 | Index of defined terms used in this particular standard |
