IEC TR 60601-4-3:2018

IEC TR 60601-4-3 ®
Edition 2.0 2018-12
REDLINE VERSION
TECHNICAL
REPORT
colour
inside
Medical electrical equipment –
Part 4-3: Guidance and interpretation – Considerations of unaddressed safety
aspects in the third edition of IEC 60601-1 and proposals for new requirements

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IEC TR 60601-4-3 ®
Edition 2.0 2018-12
REDLINE VERSION
TECHNICAL
REPORT
colour
inside
Medical electrical equipment –

Part 4-3: Guidance and interpretation – Considerations of unaddressed safety

aspects in the third edition of IEC 60601-1 and proposals for new requirements

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-6351-8

– 2 – IEC TR 60601-4-3:2018 RLV  IEC 2018
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope and object . 9
2 Normative references . 9
3 Terms and definitions . 11
4 Recommendations . 12
4.1 Template used for recommendations prepared by SC 62A/WG 14 . 12
4.2 Recommendation sheets . 13
4.2.101 Total PATIENT LEAKAGE CURRENT of a ME SYSTEM . 13
4.2.102 Pollution degree for MOPP . 14
4.2.103 Transients on DC mains . 14
4.2.104 Altitude factor for DEFIBRILLATION-PROOF APPLIED PARTS . 15
4.2.105 Defibrillation energy protection for MOOP/MOPP . 16
4.2.106 Overvoltage categories III and IV . 16
4.2.107 Pollution degree related to different micro/macro environments . 16
4.2.108 Warnings versus ALARM SIGNALS . 17
4.2.109 Single Y1 capacitor for MOPP . 17
4.2.110 WORKING VOLTAGE > 14 140 V peak . 18
4.2.111 CREEPAGE DISTANCE and AIR CLEARANCE for dental equipment . 18
4.2.112 Short-circuiting of one constituent part of DOUBLE INSULATION . 19
4.2.113 Instability in transport position . 19
4.2.114 When to conduct Delay time for conducting leakage current tests after
humidity preconditioning treatment . 20
4.2.115 DEFIBRILLATION-PROOF TYPE B APPLIED PARTS . 20
4.2.116 Instability excluding transport position . 21
4.2.117 DIELECTRIC STRENGTH of two serial MOPP barrier parts . 21
4.2.118 Overheating transformer . 22
4.2.119 Test equipment for recurrent tests according to IEC 62353 testing used
within IEC 60601-1 type approval testing . 23
4.2.120 Tolerances of apparatus . 25
4.2.121 FUNCTIONAL EARTH CONDUCTOR and ESSENTIAL PERFORMANCE. 26
4.2.122 AC motors . 27
4.2.123 Operational insulation . 28
4.2.124 WORKING VOLTAGE measurement . 28
4.2.125 Defibrillation test. 29
4.2.126 Oil containers for moving parts . 30
4.2.127 PERMANENTLY INSTALLED ME EQUIPMENT in the HOME HEALTHCARE
ENVIRONMENT . 30
4.2.128 Polystyrene plate for LEAKAGE CURRENT tests . 32
4.2.129 Push buttons . 33
4.2.130 Temperature limit at the ENCLOSURE in SINGLE FAULT CONDITION . 34
4.2.131 Optic coupler requirements . 35
4.2.132 Eye-verification of tester before legibility test . 37
4.2.133 End stops to prevent overtravel . 38
4.2.134 MOPP barrier with low WORKING VOLTAGE RMS and high
WORKING VOLTAGE peak . 39
4.2.135 Labeling: spare parts vs. detachable parts vs. ACCESSORIES . 40

4.2.136 Protective earth impedance of ME SYSTEM > 200 mΩ . 43
4.2.137 Ball pressure test . 44
4.2.138 Magnesium alloy ENCLOSURE. 45
4.2.139 Instability with initial movement . 46
4.2.140 Ball pressure test . 47
4.2.141 DIELECTRIC STRENGTH test values . 49
4.2.142 SECONDARY CIRCUITS . 50
4.2.143 LEAKAGE CURRENTS in SINGLE FAULT CONDITION and during component
faults . 50
4.2.144 Impedance of a PROTECTIVE EARTH CONDUCTOR within a DETACHABLE
POWER SUPPLY CORD . 51
4.2.145 Time delay of the 100 VA limit . 52
4.2.146 Test voltage multiplied by factor 1,6 . 53
4.2.147 Overflow and spillage . 53
4.2.148 DIELECTRIC STRENGTH test of transformers without accessible frame . 54
4.2.149 Expected voltage on SIP/SOPs . 54
4.2.150 Flammability rating for transformer bobbin . 55
4.2.151 COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS . 56
4.2.152 Peak and RMS WORKING VOLTAGES . 57
4.2.153 Critical components . 58
4.2.154 LEAKAGE CURRENT test for ME EQUIPMENT with multiple APPLIED PARTS . 59
4.2.155 DIELECTRIC STRENGTH test value for extruded and spirally wrapped multi-
layer wires . 60
4.2.156 DIELECTRIC STRENGTH test after thermal cycling test . 60
4.2.157 Required MOOP values higher than MOPP values . 61
4.2.158 Optocouplers . 61
4.2.159 Impact test . 62
4.2.160 Spillage test in NORMAL CONDITION and in SINGLE FAULT CONDITION . 63
4.2.161 TYPE B APPLIED PART connected to ACCESSIBLE PARTS . 64
4.2.162 Current/power labeling . 65
4.2.163 Separate power supply part of ME EQUIPMENT or ME SYSTEM . 65
4.2.164 Specification of the allowed power supply . 66
4.2.165 Mains transients for opposite polarity on the secondary side or battery
pole to pole barrier . 67
4.2.166 Keep dry and umbrella symbol . 68
4.2.167 MOBILE and STATIONARY ME EQUIPMENT with wheels . 69
4.2.168 Varistors installed in the MAINS PART . 70
4.2.169 Using Y2 capacitors for MOPP . 71
4.2.170 Overtravel end stops – Specification of the speed. 71
4.2.171 CREEPAGE DISTANCE and AIR CLEARANCE between input and output of
fuse contacts . 72
4.2.172 Examples of SINGLE FAULT CONDITION . 73
4.2.173 Examples of ME SYSTEMS . 73
4.2.174 Cross sectional area of POWER SUPPLY CORD for rated input current
> 63 A . 74
4.2.175 Biocompatibility for quasi APPLIED PARTS . 74
4.2.176 Floating reference earth. 75
4.2.177 SINGLE FAULT CONDITION in OXYGEN RICH ENVIRONMENT . 76
4.2.178 Laser requirements . 78
4.2.179 Flammability rating of insulated wires . 78

– 4 – IEC TR 60601-4-3:2018 RLV  IEC 2018
4.2.180 Infrared lamps . 79
4.2.181 Identification of internal fuses . 80
4.2.182 Chargers for ME EQUIPMENT used at home . 81
4.2.183 CLASS II ME EQUIPMENT with FUNCTIONAL
...