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ANSI/AAMI/IEC 60601-2-25:2011/(R)2016 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs, 2011
- ANSI/AAMI/IEC 60601-2-25:2011/(R)2016, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- Objectives and uses of AAMI standards and recommended practices
- Title Page
- AAMI Standard
- Copyright information
- Table of contents
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of IEC 60601-2-25:2011
- Foreword
- Introduction
- 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]
- 201.4.3 Essential performance [Go to Page]
- 201.4.3.101 Additional 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
- 201.6.6 Mode of operation
- 201.7 ME
equipment identification, marking and documents [Go to Page]
- 201.7.4 Making of controls and instruments [Go to Page]
- 201.7.4.101 * Patient cable and patient cable to me equipment connector
- 201.7.9.2 Instructions for use [Go to Page]
- 201.7.9.2.101 Additional instructions for use
- 201.8 Protection against electrical hazards from me equipment [Go to Page]
- 201.8.3 Classification of applied parts
- 201.8.5 Separation of parts
[Go to Page]
- 201.8.5.2.3 Patient leads
- 201.8.5.5.1 Defibrillation protection
- 201.8.5.5.2 Energy reduction test
- 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
- 201.12 Accuracy of controls and instruments and protection against hazardous outputs [Go to Page]
- 201.12.1 Accuracy of controls and instruments
[Go to Page]
- 201.12.1.101 Essential performance and accuracy of ME
equipment
- 201.12.1.101.1 Automated measurements on ECGs
- 201.12.1.101.2 * Requirements for amplitude measurements
- 201.12.1.101.3 Requirements for interval measurements
- 201.12.1.101.3.1 * Requirements for absolute interval and wave duration measurements
- 201.12.1.101.3.2 * Requirements for interval measurements on biological ecgs
- 201.12.4.101 * Indication of inoperable electrocardiograph
- 201.12.4.102 Leads
- 201.12.4.102.1 lead representation, nomenclature and definition
- 201.12.4.102.2 Minimum required configuration
- 201.12.4.102.3 Test of lead networks
- 201.12.4.102.3.1 General
- 201.12.4.102.3.2 Goldberger and Wilson leads
- 201.12.4.102.4 Recovery time
- 201.12.4.103 * Input impedance
- 201.12.4.104 Required gains
- 201.12.4.105 Reduction of the effects of unwanted external voltages
- 201.12.4.105.1 * Common mode rejection
- 201.12.4.105.2 * Overload tolerance
- 201.12.4.105.3 * Filters (including line frequency interference filters)
- 201.12.4.106 Baseline
- 201.12.4.106.1 * Noise level
- 201.12.4.106.2 Channel crosstalk
- 201.12.4.107 Distortion
- 201.12.4.107.1 * Frequency response
- 201.12.4.107.1.1 Tests with sinusoidal and impulse signals
- 201.12.4.107.1.1.1 High frequency response
- 201.12.4.107.1.1.2 Low frequency (impulse) response
- 201.12.4.107.1.2 Test with calibration ecgs
- 201.12.4.107.2 Linearity and dynamic range
- 201.12.4.107.3 Sampling and amplitude quantization during data acquisition
- 201.12.4.108 Printing, electronic storage and transmission
- 201.12.4.108.1 Record identification
- 201.12.4.108.2 Patient identification
- 201.12.4.108.3 Ecg reporting on paper
- 201.12.4.108.3.1 Time and event markers
- 201.12.4.108.3.2 Recording speed
- 201.12.4.108.3.3 Time and amplitude ruling
- 201.12.4.109 Use with cardiac pacemakers
- 201.13 Hazardous situations and fault conditions
- 201.14 Programmable electrical medical systems (PEMS
)
- 201.15 Construction of ME
equipment
- 201.16 ME
systems
- 201.17 Electromagnetic compatibility of ME equipment and ME
systems
- 202 Electromagnetic compatibility – Requirements and tests [Go to Page]
- 202.5.2.2.2 Requirements applicable to ME equipment and ME systems other than those specified for use only in a shielded location
- 202.6.1 Emissions
- 202.6.1.1.2 Tests
- 202.6.2 Immunity
- 202.6.2.1.10 *Compliance criteria
- 202.6.2.2 Electrostatic discharge (ESD
)
- 202.6.2.2.1 Requirements
- 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
- 202.6.2.6 Conducted disturbances, induced by RF fields
- 202.6.2.6.1 Requirements
- 202.6.2.6.2 Tests
- 202.6.2.101 * Electrosurgery interference
- Annexes
- Annex AA, Particular guidance and rationale
[Go to Page]
- AA.1 General considerations
- AA.2 Guidance and rationale for particular subclauses
[Go to Page]
- Subclause 201.1.1 -- Scope
- Subclause 201.5.3 -- Ambient temperature, humidity, atmospheric pressure
- Subclause 201.5.8 -- Sequence of tests
- Subclause 201.7.4.101 -- Patient cable and patient cable to ME equipment connector
- Subclause 201.7.9.2.101 a) 14) -- Additional instructions for use
- Subclause 201.8.5.5.1 -- Defibrillation protection
- Subclause 201.12.1.101.1 -- Automated measurements on ECGs
- Subclause 201.12.1.101.2 -- Requirements for amplitude measurements
- Subclause 201.12.1.101.3.1 -- Requirements for absolute interval and wave duration measurements
- Subclause 201.12.1.101.3.2 -- Requirements for interval measurements on biological ECGs
- Subclause 201.12.4.101 -- Indication of inoperable electrocardiographs
- Subclause 201.12.4.103 -- Input impedance
- Subclause 201.12.4.105.1 -- Common mode rejection
- Subclause 201.12.4.105.2 -- Overload tolerance
- Subclause 201.12.4.105.3 -- Filters (including line frequency interference filters)
- Subclause 201.12.4.106.1 -- Noise level
- Subclause 201.12.4.107.1 -- Frequency response
- Subclause 202.6.2.1.10 -- Compliance criteria
- Subclause 202.6.2.101 -- Electrosurgery interference
- AA.3 Guidelines to input ECG data to electrocardiographs
- Annex BB, Electrodes, their positions, identifications and color codes
- Annex CC, Leads, their identification and color codes (other than those specified in 201.12.4.102)
[Go to Page]
- CC.1 Unipolar chest leads according to Wilson
- CC.2 Bipolar chest leads
- CC.3 Unipolar limb leads
- CC.4 Chest leads Nehb
- Annex DD, Polarity of patient leads (other than those specified in 201.12.4.102)
- Annex EE, Additional marking of electrodes
[Go to Page]
- EE.1 Combined use electrodes
- EE.2 Combined standard and Frank electrodes
- Annex FF, Definitions and rules for the measurement of electrocardiograms
[Go to Page]
- FF.1 The electrocardiogram
- FF.2 Determination of global intervals
- FF.3 Waveform durations, isoelectric segments
- FF.4 Baseline (amplitude measurement references)
- FF.5 Definition of waveforms, measurement of minimum waves
- FF.6 Acceptance of minimum waves
- Annex GG, Calibration and test data sets
[Go to Page]
- GG.1 Calibration and analytical ECGs
- GG.2 Biological ECGs
- Annex HH, CTS test atlas
[Go to Page]
- HH.1 Introduction
- HH.2 The test database
[Go to Page]
- HH.2.1 Rationale
- HH.2.2 Set-up of the test database
- HH.2.3 Calibration ECGs
- HH.2.4 Analytical ECGs
- HH.3 Signal characteristics
- HH.4 List of ECGs
[Go to Page]
- HH.4.1 Calibration ECGs
- HH.4.2 Analytical ECGs
- HH.5 Wave duration tables adapted for different amplitude quantization
[Go to Page]
- HH.5.1 CALECG Wave On-/Offsets, Sample R
ate = 1000 S/s
- HH.5.2 CALECG Interval Durations, Sample Rate = 1,000 S/s
- HH.5.3 CALECG Wave On-/Offsets, Sample Rate = 500 S/s
- HH.5.4 CALECG Interval Durations, Sample Rate = 500 S/s
- Bibliography
- Index of defined terms used in this particular standard
[Go to Page]