AS/NZS IEC 60601.2.27:2016
Medical electrical equipment - Part 2.27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Establishes particular requirements for basic safety and essential performance of electrocardiographic (ECG) monitoring equipment, which are defined as devices including electrodes, lead wires and interconnecting means for the monitoring and/or recording of heart action potentials from one patient and displaying the resultant data.Identical to and reproduced from IEC 60601-2-27, Ed.3.0 (2011) with its Corrigendum 1:2012.
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CONTENTS
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
01.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
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 hazardousoutputs
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
208 General requirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systems
Annexes
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006
Bibliography
Index of defined terms used in this particular standard
Figure
Figure 201.101 – Alternating QRS complexes and ventricular tachycardia waveformsfor testing pattern recognition capability according to 201.7.9.2.9.101 b) 4) and 6).
Figure 201.102 – Test of protection against the effects of defibrillation (differentialmode)
Figure 201.103 – Test of protection against the effects of defibrillation (common mode)
Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energydelivered by the defibrillator
Figure 201.105 – General test circuit
Figure 201.106 – High frequency response
Figure 201.107 – Test circuit for COMMON MODE REJECTION
Figure 201.108 – Baseline reset
Figure 201.109 – Pacemaker pulse
Figure 201.110 – Test waveforms for T-wave rejection
Figure 201.111 – Normal paced rhythm
Figure 201.112 – Ineffective pacing (heart rate at 30 1/min, pacemaker pulse at80 1/min)
Figure 201.113 – Simulated QRS complex
Figure 201.114 – Pacemaker test circuit
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiatedimmunity test
Figure 202.102 – Set-up for radiated IMMUNITY test
Figure 202.103 – Test circuit for HF surgery protection measurement
Figure 202.104 – Test setup for HF surgery protection measurement
Figure AA.1 – APPLIED PART with multiple PATIENT CONNECTIONS
Figure BB.101 – NON-LATCHING ALARM SIGNALS without ALARM RESET
Figure BB.102 – NON-LATCHING ALARM SIGNALS with ALARM RESET
Figure BB.103 – LATCHING ALARM SIGNALS with ALARM RESET
Figure BB.104 – Two ALARM CONDITIONS with ALARM RESET
Table
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Table 201.102 – ELECTRODES and NEUTRAL ELECTRODE, their position, identification andcolour
Table 201.103 – Protection against the effect of defibrillation (test conditions)
Table 208.101 – ALARM CONDITION priorities
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS
Table AA.1 – Electrode positions and electrical strength requirements
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References
Medical electrical equipment - Part 2.2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Related Information
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CONTENTS
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
01.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
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 hazardousoutputs
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
208 General requirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systems
Annexes
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006
Bibliography
Index of defined terms used in this particular standard
Figure
Figure 201.101 – Alternating QRS complexes and ventricular tachycardia waveformsfor testing pattern recognition capability according to 201.7.9.2.9.101 b) 4) and 6).
Figure 201.102 – Test of protection against the effects of defibrillation (differentialmode)
Figure 201.103 – Test of protection against the effects of defibrillation (common mode)
Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energydelivered by the defibrillator
Figure 201.105 – General test circuit
Figure 201.106 – High frequency response
Figure 201.107 – Test circuit for COMMON MODE REJECTION
Figure 201.108 – Baseline reset
Figure 201.109 – Pacemaker pulse
Figure 201.110 – Test waveforms for T-wave rejection
Figure 201.111 – Normal paced rhythm
Figure 201.112 – Ineffective pacing (heart rate at 30 1/min, pacemaker pulse at80 1/min)
Figure 201.113 – Simulated QRS complex
Figure 201.114 – Pacemaker test circuit
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiatedimmunity test
Figure 202.102 – Set-up for radiated IMMUNITY test
Figure 202.103 – Test circuit for HF surgery protection measurement
Figure 202.104 – Test setup for HF surgery protection measurement
Figure AA.1 – APPLIED PART with multiple PATIENT CONNECTIONS
Figure BB.101 – NON-LATCHING ALARM SIGNALS without ALARM RESET
Figure BB.102 – NON-LATCHING ALARM SIGNALS with ALARM RESET
Figure BB.103 – LATCHING ALARM SIGNALS with ALARM RESET
Figure BB.104 – Two ALARM CONDITIONS with ALARM RESET
Table
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Table 201.102 – ELECTRODES and NEUTRAL ELECTRODE, their position, identification andcolour
Table 201.103 – Protection against the effect of defibrillation (test conditions)
Table 208.101 – ALARM CONDITION priorities
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS
Table AA.1 – Electrode positions and electrical strength requirements
Previous versions
AS/NZS IEC 60601.2.27:2016
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.