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eLibrary > ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text) - Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 >

ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text) - Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1, 2010

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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text) - Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1, 2010

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 (Consolidated Text)
AAMI Standard
Title page
AAMI Standard
Copyright information
Contents
Committee representation
Background of ANSI/AAMI adoption of IEC 60601-2-4:2010/A1:2018
Foreword
201.1 Scope, object and related standards [Go to Page]
201.1. 1 * Scope
201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 Particular standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements [Go to Page]
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 [Go to Page]
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
201.5 General requirements for testing of me equipment [Go to Page]
201.5.3 * Ambient temperature, humidity, atmospheric pressure
201.5.4 Other conditions
201.5.8 Sequence of tests
201.6 Classification of me equipment and me systems [Go to Page]
201.6.2 * Protection against electric shock
201.7 Me equipment identification, marking and documents [Go to Page]
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
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
201.7.9.2.101 * Supplementary instructions for use
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
201.7.9.3.103 * Essential performance data of the rhythm recognition detector
201.8 Protection against electrical hazards from me equipment [Go to Page]
201.8.3 * Classification of applied parts
201.8.5.5.1 * Defibrillation protection
201.8.5.5.101 * Isolation of defibrillator electrodes [Go to Page]
Figure 201.101 – Dynamic test for limitation of energy from 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
201.8.7.3 * Allowable values
201.8.7.4.7 Measurement of the patient leakage current
201.8.8.3 * Dielectric strength [Go to Page]
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
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 [Go to Page]
201.11.1.3 Measurements
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
201.11.6.7 * Sterilization of me equipment and me systems
201.12 * Accuracy of controls and instruments and protection against hazardous outputs [Go to Page]
201.12.1 * Accuracy of controls and instruments
201.12.2 Usability
201.12.2.101 * ELECTRODE energizing controls
201.12.2.102 Display of signals
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
201.12.4.103 * Internal discharge circuit
201.13 Hazardous situations and fault conditions [Go to Page]
201.13.1.3 * Exceeding leakage current or voltage limits
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment [Go to Page]
201.15.4 * Me equipment components and general assembly [Go to Page]
Figure 201.103 – Examples of cord anchorages that require testing
Figure 201.104 – Test apparatus for flexible cords and their anchorages
201.15.4.3 Batteries
201.15.4.3.101 * Battery replacement
201.15.4.3.102 Battery charging indicator
201.15.4.3.103 * Rechargeable battery
201.15.4.101 * Defibrillator electrodes and their cables
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 * Charging time [Go to Page]
201.101.1 Requirements for frequent use, manual defibrillators
201.101.2 Requirements for infrequent use, manual defibrillators
201.101.3 * Requirements for frequent use, automated external defibrillators
201.101.4 * Requirements for infrequent use, automated external defibrillators
201.102 Internal electrical power source [Go to Page]
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
201.102.3.2 Infrequent use AED
201.103 * Endurance
201.104 * Synchronizer
201.105 * Recovery of the monitor and/or ECG input after defibrillation [Go to Page]
201.105.1 ECG signal derived via defibrillator electrodes [Go to Page]
Figure 201.105 – Arrangement for test of recovery after defibrillation
201.105.2 ECG signal derived via any separate monitoring electrodes [Go to Page]
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
201.106 * Disturbance to the monitor from charging or internal discharging [Go to Page]
Figure 201.108 – Arrangement for test of disturbance from charging and internal discharging
201.107 * Requirements for rhythm recognition detector [Go to Page]
Table 201.102 – RHYTHM RECOGNITION DETECTOR categories
201.108 Defibrillator electrodes [Go to Page]
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 [Go to Page]
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
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 [Go to Page]
201.109.1 Pacing mode activation
201.109.2 Pacing delivery
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
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
201.109.5.2 Pacing rate stability
201.109.6 Pacing protocol
201.109.7 Demand pacing
201.109.8 Pacer lead-off indication [Go to Page]
Figure 201.110 – Test circuit for DEFIBRILLATOR overload test of pacing output circuitry
202 * Electromagnetic compatibility – Requirements and tests [Go to Page]
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
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
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
Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems [Go to Page]
201.C.1 Marking on the outside of me equipment, me systems or their parts [Go to Page]
Table 201.C.101 – Marking on the outside of a CARDIAC DEFIBRILLATOR or its parts
201.C.3 Marking of controls and instruments [Go to Page]
Table 201.C.102 – Marking of controls and instruments of a CARDIAC DEFIBRILLATOR
201.C.4 Accompanying documents, general [Go to Page]
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general
201.C.5 Accompanying documents, Instructions for use [Go to Page]
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use
201.C.6 Accompanying documents, technical description [Go to Page]
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description
Annex AA (informative) Particular guidance and rationale [Go to Page]
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses [Go to Page]
Figure AA.1 – Simulated PATIENT load
Annex BB (informative) Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010 [Go to Page]
Table BB.1 – Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010
Bibliography
Index of defined terms used in this particular standard [Go to Page]

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