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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, 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 (Redline Version)
- 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 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
- 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
- 201.12.3 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
- 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
- 201.15.4.3 Batteries
- 201.15.4.3.101 * Non-rechargeable 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 [Go to Page]
- Figure 201.103 – Examples of cord anchorages that require testing
- Figure 201.104 – Test apparatus for flexible cords and their anchorages
- 201.16 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 chargingand 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
- 201.108.1.3 * Combined offset instability and internal noise [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 (U.S.) [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
- Subclause 201.4.2.101 – Additional risk management requirements
- Subclause 201.4.3.101 – Additional essential performance requirements
- 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]