AAMI 60601 2 27 2011 RA 2016
$140.32
ANSI/AAMI/IEC 60601-2-27:2011/(R)2016 – Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
| Published By | Publication Date | Number of Pages |
| AAMI | 2011 | 86 |
This standard specifies basic safety requirements and essential performance for electrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment used in a hospital environment. If it is used outside the hospital environment, such as in ambulances and air transport, the ECG monitoring equipment shall comply with this standard. This standard is not applicable to electrocardiographic monitors for home use and ECG telemetry systems. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use/intended purpose. Ambulatory (“Holter”) monitors, fetal heart rate monitors, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | Title page |
| 3 | AAMI Standard Copyright page |
| 4 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of IEC 60601-2-27:2011 |
| 10 | Foreword |
| 12 | Introduction |
| 14 | 201.1 Scope, object and related standards 201.1.1 Scope 201.1.2 Object 201.1.3 Collateral standards |
| 15 | 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 |
| 19 | 201.5 General requirements for testing of me equipment 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 |
| 20 | 201.6. 6 Mode of operation 201.7 Me equipment identification, marking and documents 201.7. 2.4 Accessories 201.7. 2.4.101 Marking of lead wires |
| 21 | 201.7. 9.2.9 Operating instructions 201.7. 9.2.9.101 Additional instructions for use |
| 25 | 201.8 Protection against electrical hazards from me equipment 201.8. 3 Classification of applied parts 201.8. 5.2.3 * Patient leads 201.8. 5.5 Defibrillation-proof applied parts 201.8. 5.5.1 * Defibrillation protection |
| 29 | 201.8.5.5.2 Energy reduction test |
| 30 | 201.9 Protection against mechanical hazards of me equipment and me systems 201.10 Protection against unwanted and excessive radiation hazards |
| 31 | 201.11 Protection against excessive temperatures and other hazards 201.11. 6.5 * Ingress of water or particulate matter into me equipment and me systems 201.11. 8 * Interruption of the power supply / supply mains to me equipment |
| 32 | 201.11. 8.101 * Protection against depletion of battery |
| 33 | 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 of me equipment 201.12.1.101.1 Accuracy of signal reproduction |
| 35 | 201.12. 1.101.2 * Input dynamic range and differential offset voltage 201.12. 1.101.3 * Input impedance 201.12. 1.101.4 Input noise |
| 36 | 201.12. 1.101.5 Multichannel crosstalk |
| 37 | 201.12. 1.101.6 Gain control and stability 201.12. 1.101.7 Sweep speed |
| 38 | 201.12. 1.101.8 * Frequency and impulse response |
| 39 | 201.12. 1.101.9 Gain indicator |
| 40 | 201.12. 1.101.10 * Common mode rejection |
| 41 | 201.12. 1.101.11 Baseline reset |
| 42 | 201.12. 1.101.12 * Pacemaker pulse display capability |
| 43 | 201.12. 1.101.13 Rejection of pacemaker pulses |
| 47 | 201.12. 1.101.14 Synchronizing pulse for cardioversion 201.12. 1.101.15 * Heart rate range, accuracy, and QRS detection range |
| 49 | 201.12. 1.101.16 * Channel height and aspect ratio 201.12. 1.101.17 Tall T-wave rejection capability 201.12. 3 Alarm systems |
| 50 | 201.12.4 Protection against hazardous output 201.12.4.101.1 Indications on permanent displays and non-permanent displays 201.13 Hazardous situations and fault conditions 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.15. 3.4 Drop test 201.15. 3.4.101 * Electrodes and patient cables |
| 51 | 201.15. 4.4 Indicators 201.15. 4.4.101 Indicator of battery operation and battery status 201.16 Me systems 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 Electromagnetic compatibility 202.6.1 Emissions 202.6.1.1.2 Tests |
| 52 | 202.6.2 Immunity 202.6.2.1.10 Compliance criteria |
| 53 | 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 |
| 54 | 202.6.2.4 Electrical fast transients and bursts 202.6.2.4.1 Requirements |
| 55 | 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 |
| 57 | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.6 Alarm systems 208.6.1 Alarm condition 208.6.1.2 Alarm condition priority |
| 58 | 208.6.3.3 Auditory alarm signals 208.6.3.3.1 *Characteristics of auditory alarm signals |
| 60 | 208.6.3.3.2 Volume of auditory alarm signals and information signals 208.6.3.3.2.101 * Volume of auditory alarm signals reducible to zero 208.6.4.2 *Delays to or from a distributed alarm system 208.6.6 Alarm limit 208.6.6.2 Adjustable alarm limit 208.6.6.2.101 Adjustment range of heart rate alarm limits 208.6.6.2.102 Resolution of alarm limit settings 208.6.6.2.103 Time to alarm for heart rate alarm conditions |
| 61 | 208.6.6.2.104 *Technical alarm condition indicating inoperable me equipment 208.6.6.2.105 Assignment of alarm condition priority |
| 62 | 208.6.8 Alarm signal inactivation states 208.6.8.101 *Technical alarm conditions 208.6.9 *Alarm reset |
| 63 | 208.6.10 *Non-latching and latching alarm signals 208.6.10.101 *Non-latching alarm signals for technical alarm conditions 208.6.11 Distributed alarm system 208.6.11.2.2 *Failure of remote communication of alarm conditions 208.6.11.101 *Inactivation/activation of alarm signals at remote components of a distributed alarm system |
| 64 | Annexes |
| 65 | Annex AA Particular guidance and rationale AA.1 Use with defibrillator AA.2 Rationale for defibrillator tes t voltages AA.2.1 General |
| 66 | AA.2.2 Summary AA.2.3 Specific requirement AA.3 Guidance and rationale for particular clauses Subclause 201.1.1 — Scope Subclause 201.5.8 — Sequence of tests Subclause 201.6.2 — Protection against electric shock |
| 67 | Subclause 201.7.9.2.9.101 a) 4) — Additional instructions for use Subclause 201.7.9.2.9.101 a) 7) — Additional instructions for use Subclause 201.8.5.2.3 — Patient leads |
| 69 | Subclause 201.8.5.5.1 — Defibrillation protection Subclause 201.11.6.5 — Ingress of water or particulate matter into me equipment and me systems Subclause 201.11.8 — Interruption of the power supply/supply mains to the me equipment Subclause 201.11.8.101 — Protection against depletion of battery |
| 70 | Subclause 201.12.1.101 — Essential performance of me equipment |
| 71 | Subclause 201.12.1.101.2 — Input dynamic range and differential offset voltage Subclause 201.12.1.101.3 — Input impedance Subclause 201.12.1.101.8 — Frequency and impulse response Subclause 201.12.1.101.10 — Common mode rejection |
| 72 | Subclause 201.12.1.101.12 — Pacemaker pulse display capability Subclause 201.12.1.101.15 — Heart rate range, accuracy, and QRS detection range Subclause 201.12.1.101.16 — Channel height and aspect ratio |
| 73 | Subclause 201.15.3.4.101 — Electrodes and patient cables Subclause 202.6.2.6.1 bb) — Requirements Subclause 202.6.2.101 — Electrosurgery interference Subclause 208.6.1.2 — Alarm condition priority Subclause 208.6.3.3.1 Characteristics of auditory alarm signals |
| 74 | Subclause 208.6.3.3.2.101 — Volume of auditory alarm signals reducible to zero Subclause 208.6.4.2 — Delays to or from a distributed alarm system Subclause 208.6.6.2.104 — Technical alarm condition indicating inoperable me equipment Subclause 208.6.8.101 — Technical alarm conditions |
| 75 | Subclause 208.6.9 — Alarm reset Subclause 208.6.10 — Non-latching and latching alarm signals |
| 76 | Subclause 208.6.10.101 — Non-latching alarm signals for technical alarm conditions Subclause 208.6.11.2.2 — Failure of remote communication of alarm conditions Subclauses 208.6.11.101 — Inactivation/activation of alarm signals at remote components of a distributed alarm system |
| 78 | Annex BB Alarm diagrams of Clause 208/IEC 60601-1-8:2006 |
| 81 | Bibliography |
| 82 | Index of defined terms used in this particular standard |
| 85 | Erratum – ANSI/AAMI/IEC 60601-2-27:2011 – Erratum issued: 31 May 2012 |
