IEC TR 60601-4-3:2015

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

IEC TR 60601-4-3:2015(E) is intended to convey the results of WG 14's work to interested parties such as manufacturers and test laboratories while retaining the informative nature of the material. This first edition contains 93 recommendations, numbered 101 to 193. All these recommendations are based upon IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

General Information

• Status: Published
• Publication Date: 12-Apr-2015
• ICS: 11.040.01 - Medical equipment in general
• ICS: 27.160 - Solar energy engineering
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: WG 14 - TC 62/SC 62A/WG 14
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 13-Dec-2018

Relations

• Revised: IEC TR 60601-4-3:2018 - 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC TR 60601-4-3 ®
Edition 1.0 2015-04
TECHNICAL
REPORT
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 1.0 2015-04
TECHNICAL
REPORT
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 ISBN 978-2-8322-2613-1

– 2 – IEC TR 60601-4-3:2015  IEC 2015

CONTENTS
FOREWORD . 5

INTRODUCTION . 7

1 Scope and object . 8

1.1 Scope . 8

1.2 Object . 8

2 Normative references . 8

3 Recommendations . 9

3.1 Template used for recommendations prepared by SC 62A/WG 14 . 9
3.2 Recommendation sheets . 10
3.2.101 Total PATIENT LEAKAGE CURRENT of a ME SYSTEM . 10
3.2.102 Pollution degree for MOPP . 10
3.2.103 Transients on d.c. mains . 11
3.2.104 Altitude factor for DEFIBRILLATION-PROOF APPLIED PARTS . 12
3.2.105 Defibrillation energy protection for MOOP / MOPP . 13
3.2.106 Overvoltage categories III and IV . 13
3.2.107 Pollution degree related to different micro/macro environments . 13
3.2.108 Warnings versus ALARM SIGNALS . 14
3.2.109 Single Y1 capacitor for MOPP . 14
3.2.110 WORKING VOLTAGE > 14 140 V peak . 15
3.2.111 CREEPAGE DISTANCE and AIR CLEARANCE for dental equipment . 15
3.2.112 Short circuiting of one constituent part of DOUBLE INSULATION . 16
3.2.113 Instability in transport position . 16
3.2.114 When to conduct leakage current tests after humidity preconditioning
treatment . 17
3.2.115 DEFIBRILLATION-PROOF TYPE B APPLIED PARTS . 17
3.2.116 Instability excluding transport position . 18
3.2.117 DIELECTRIC STRENGTH of two serial MOPP barrier parts . 18
3.2.118 Overheating transformer . 19
3.2.119 Test equipment for recurrent tests according to IEC 62353 testing used
within IEC 60601-1 type approval testing . 20
3.2.120 Tolerances of apparatus . 22
3.2.121 FUNCTIONAL EARTH CONDUCTOR and ESSENTIAL PERFORMANCE . 23

3.2.122 A.c. motors . 24
3.2.123 Operational insulation . 25
3.2.124 WORKING VOLTAGE measurement . 25
3.2.125 Defibrillation test. 26
3.2.126 Oil containers for moving parts . 27
3.2.127 PERMANENTLY INSTALLED ME EQUIPMENT in the HOME HEALTHCARE
ENVIRONMENT . 27
3.2.128 Polystyrene plate for LEAKAGE CURRENT tests . 30
3.2.129 Push buttons . 31
3.2.130 Temperature limit at the ENCLOSURE in SINGLE FAULT CONDITION . 31
3.2.131 Optic coupler requirements . 33
3.2.132 Eye-verification of tester before legibility test . 35
3.2.133 End stops to prevent overtravel . 36
3.2.134 MOPP barrier with low WORKING VOLTAGE r.m.s. and high
WORKING VOLTAGE peak . 37

3.2.135 Labeling: spare parts vs. detachable parts vs. ACCESSORIES . 38

3.2.136 Protective earth impedance of ME SYSTEM >200 mΩ . 41

3.2.137 Ball pressure test . 42

3.2.138 Magnesium alloy ENCLOSURE. 43

3.2.139 Instability with initial movement . 44

3.2.140 Ball pressure test . 45

3.2.141 DIELECTRIC STRENGTH test values . 47

3.2.142 SECONDARY CIRCUITS . 48

3.2.143 LEAKAGE CURRENTS in SINGLE FAULT CONDITION and during component

faults . 48

3.2.144 Impedance of a PROTECTIVE EARTH CONDUCTOR within a DETACHABLE
POWER SUPPLY CORD . 49
3.2.145 Time delay of the 100 VA limit . 50
3.2.146 Test voltage multiplied by factor 1,6 . 51
3.2.147 Overflow, spillage, … . 51
3.2.148 DIELECTRIC STRENGTH test of transformers without accessible frame . 52
3.2.149 Expected voltage on SIP/SOPs . 52
3.2.150 Flammability rating for transformer bobbin . 53
3.2.151 COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS . 54
3.2.152 Peak and r.m.s. WORKING VOLTAGES . 55
3.2.153 Critical components . 56
3.2.154 LEAKAGE CURRENT test for ME EQUIPMENT with multiple APPLIED PARTS . 56
3.2.155 DIELECTRIC STRENGTH test value for extruded and spirally wrapped multi-
layer wires . 57
3.2.156 DIELECTRIC STRENGTH test after thermal cycling test . 57
3.2.157 Required MOOP values higher than MOPP values . 58
3.2.158 Optocouplers . 58
3.2.159 Impact test . 59
3.2.160 Spillage test in NORMAL CONDITION and in SINGLE FAULT CONDITION . 60
3.2.161 TYPE B APPLIED PART connected to ACCESSIBLE PARTS . 61
3.2.162 Current/power labeling . 62
3.2.163 Separate power supply part of ME EQUIPMENT or ME SYSTEM . 62
3.2.164 Specification of the allowed power supply . 63
3.2.165 Mains transients for opposite polarity on the secondary side or battery
pole to pole barrier . 64
3.2.166 Keep dry and umbrella symbol . 65

3.2.167 MOBILE and STATIONARY ME EQUIPMENT with wheels . 66
3.2.168 Varistors installed in the MAINS PART . 67
3.2.169 Using Y2 capacitors for MOPP . 67
3.2.170 Overtravel end stops – specification of the speed . 68
3.2.171 CREEPAGE DISTANCE and AIR CLEARANCE between input and output of
fuse contacts . 69
3.2.172 Examples of SINGLE FAULT CONDITION . 69
3.2.173 Examples of ME SYSTEMS . 70
3.2.174 Cross sectional area of POWER SUPPLY CORD for rated input current
> 63 A . 70
3.2.175 Biocompatibility for quasi APPLIED PARTS . 71
3.2.176 Floating reference earth. 71
3.2.177 SINGLE FAULT CONDITION in OXYGEN RICH ENVIRONMENT . 72
3.2.178 Laser requirements . 74

– 4 – IEC TR 60601-4-3:2015  IEC 2015

3.2.179 Flammability rating of insulated wires . 74

3.2.180 Infrared lamps . 75

3.2.181 Identification of internal fuse
...