AAMI 60601 2 25 2011 RA 2016
$195.75
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
| Published By | Publication Date | Number of Pages |
| AAMI | 2011 | 107 |
This standard specifies requirements for infant phototherapy equipment and can also be applied to infant phototherapy equipment used for compensation or alleviation of disease, injury or disability.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | Title Page |
| 3 | AAMI Standard Copyright information |
| 4 | Table of contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of IEC 60601-2-25:2011 |
| 11 | Foreword |
| 13 | Introduction |
| 14 | 201.1 Scope, object and related standards 201.1.1 * Scope |
| 15 | 201.1.2 Object 201.1.3 Collateral standards 201.1.4 Particular standards |
| 16 | 201.2 Normative references 201.3 Terms and definitions |
| 18 | 201.4 General requirements 201.4.3 Essential performance 201.4.3.101 Additional essential performance requirements 201.5 General requirements for testing of me equipment |
| 19 | 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 201.6.2 Protection against electric shock 201.6.6 Mode of operation |
| 20 | 201.7 ME equipment identification, marking and documents 201.7.4 Making of controls and instruments 201.7.4.101 * Patient cable and patient cable to me equipment connector |
| 22 | 201.7.9.2 Instructions for use 201.7.9.2.101 Additional instructions for use |
| 23 | 201.8 Protection against electrical hazards from me equipment 201.8.3 Classification of applied parts |
| 24 | 201.8.5 Separation of parts 201.8.5.2.3 Patient leads 201.8.5.5.1 Defibrillation protection |
| 28 | 201.8.5.5.2 Energy reduction test |
| 29 | 201.9 Protection against mechanical hazards of me equipment and me systems 201.10 Protection against unwanted and excessive radiation hazards |
| 30 | 201.11 Protection against excessive temperatures and other hazards 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12.1 Accuracy of controls and instruments 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 |
| 31 | 201.12.1.101.3.2 * Requirements for interval measurements on biological ecgs |
| 32 | 201.12.4.101 * Indication of inoperable electrocardiograph 201.12.4.102 Leads 201.12.4.102.1 lead representation, nomenclature and definition |
| 33 | 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 |
| 34 | 201.12.4.102.4 Recovery time 201.12.4.103 * Input impedance 201.12.4.104 Required gains |
| 35 | 201.12.4.105 Reduction of the effects of unwanted external voltages 201.12.4.105.1 * Common mode rejection |
| 36 | 201.12.4.105.2 * Overload tolerance |
| 37 | 201.12.4.105.3 * Filters (including line frequency interference filters) 201.12.4.106 Baseline 201.12.4.106.1 * Noise level |
| 38 | 201.12.4.106.2 Channel crosstalk |
| 39 | 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 |
| 40 | 201.12.4.107.1.1.2 Low frequency (impulse) response |
| 41 | 201.12.4.107.1.2 Test with calibration ecgs 201.12.4.107.2 Linearity and dynamic range |
| 42 | 201.12.4.107.3 Sampling and amplitude quantization during data acquisition |
| 43 | 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 |
| 44 | 201.12.4.108.3.3 Time and amplitude ruling 201.12.4.109 Use with cardiac pacemakers |
| 45 | 201.13 Hazardous situations and fault conditions 201.14 Programmable electrical medical systems (PEMS ) 201.15 Construction of ME equipment 201.16 ME systems |
| 46 | 201.17 Electromagnetic compatibility of ME equipment and ME systems 202 Electromagnetic compatibility – Requirements and tests 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 |
| 47 | 202.6.2 Immunity 202.6.2.1.10 *Compliance criteria |
| 48 | 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 |
| 49 | 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 |
| 50 | 202.6.2.101 * Electrosurgery interference |
| 52 | Annexes |
| 53 | Annex AA, Particular guidance and rationale AA.1 General considerations AA.2 Guidance and rationale for particular subclauses Subclause 201.1.1 — Scope Subclause 201.5.3 — Ambient temperature, humidity, atmospheric pressure Subclause 201.5.8 — Sequence of tests |
| 54 | 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 |
| 56 | 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 |
| 57 | 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) |
| 58 | Subclause 201.12.4.106.1 — Noise level Subclause 201.12.4.107.1 — Frequency response |
| 59 | Subclause 202.6.2.1.10 — Compliance criteria Subclause 202.6.2.101 — Electrosurgery interference AA.3 Guidelines to input ECG data to electrocardiographs |
| 61 | Annex BB, Electrodes, their positions, identifications and color codes |
| 63 | Annex CC, Leads, their identification and color codes (other than those specified in 201.12.4.102) CC.1 Unipolar chest leads according to Wilson CC.2 Bipolar chest leads CC.3 Unipolar limb leads CC.4 Chest leads Nehb |
| 64 | Annex DD, Polarity of patient leads (other than those specified in 201.12.4.102) |
| 65 | Annex EE, Additional marking of electrodes EE.1 Combined use electrodes EE.2 Combined standard and Frank electrodes |
| 66 | Annex FF, Definitions and rules for the measurement of electrocardiograms FF.1 The electrocardiogram FF.2 Determination of global intervals |
| 67 | FF.3 Waveform durations, isoelectric segments |
| 68 | FF.4 Baseline (amplitude measurement references) |
| 69 | FF.5 Definition of waveforms, measurement of minimum waves FF.6 Acceptance of minimum waves |
| 72 | Annex GG, Calibration and test data sets GG.1 Calibration and analytical ECGs |
| 73 | GG.2 Biological ECGs |
| 74 | Annex HH, CTS test atlas HH.1 Introduction HH.2 The test database HH.2.1 Rationale |
| 75 | HH.2.2 Set-up of the test database |
| 76 | HH.2.3 Calibration ECGs |
| 79 | HH.2.4 Analytical ECGs |
| 80 | HH.3 Signal characteristics |
| 81 | HH.4 List of ECGs HH.4.1 Calibration ECGs HH.4.2 Analytical ECGs |
| 101 | HH.5 Wave duration tables adapted for different amplitude quantization HH.5.1 CALECG Wave On-/Offsets, Sample R ate = 1000 S/s |
| 102 | HH.5.2 CALECG Interval Durations, Sample Rate = 1,000 S/s |
| 103 | HH.5.3 CALECG Wave On-/Offsets, Sample Rate = 500 S/s |
| 104 | HH.5.4 CALECG Interval Durations, Sample Rate = 500 S/s |
| 105 | Bibliography |
| 106 | Index of defined terms used in this particular standard |
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