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

IEC TR 60601-4-3:2018 contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of IEC 60601-1:2005 and related collateral standards in the IEC 60601 series. IEC TR 60601-4-3:2018 is primarily intended to be used by:
– manufacturers of medical electrical equipment;
– test laboratories and others responsible for assessment of compliance with IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-11:2010, IEC 60601 1 11:2015 and IEC 60601-1-12:2014;
– those developing subsequent editions of IEC 60601-1.
The recommendations in the first edition of IEC TR 62296 were considered in preparing the third edition of IEC 60601-1. Similarly, it is expected that these recommendations within IEC 60601-4-3 will be considered when preparing future revisions of IEC 60601-1 and related collateral standards in the IEC 60601 series. The object of IEC TR 60601-4-3:2018 is to make the recommendations/interpretations available to those interested in the application of the third edition of IEC 60601-1 and applicable collateral standards. IEC TR 60601-4-3:2018 cancels and replaces the first edition of IEC 60601-4-3 published in 2015. This edition constitutes a technical revision. IEC TR 60601-4-3:2018 includes the following significant technical changes with respect to the previous edition: addition of 47 new recommendations.

General Information

• Status: Published
• Publication Date: 12-Dec-2018
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: WG 14 - TC 62/SC 62A/WG 14
• Current Stage: PPUB - Publication issued
• Start Date: 25-Dec-2018
• Completion Date: 13-Dec-2018

Relations

• Revises: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC TR 60601-4-3 ®
Edition 2.0 2018-12
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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 21 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

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The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

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details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: [e-mail].
IEC TR 60601-4-3 ®
Edition 2.0 2018-12
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 978-2-8322-6278-8

– 2 – IEC TR 60601-4-3:2018  IEC 2018
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 11
4 Recommendations . 11
4.1 Template used for recommendations prepared by SC 62A . 11
4.2 Recommendation sheets . 12
4.2.101 Total PATIENT LEAKAGE CURRENT of a ME SYSTEM . 12
4.2.102 Pollution degree for MOPP . 13
4.2.103 Transients on DC mains . 13
4.2.104 Altitude factor for DEFIBRILLATION-PROOF APPLIED PARTS . 14
4.2.105 Defibrillation energy protection for MOOP/MOPP . 15
4.2.106 Overvoltage categories III and IV . 15
4.2.107 Pollution degree related to different micro/macro environments . 15
4.2.108 Warnings versus ALARM SIGNALS . 16
4.2.109 Single Y1 capacitor for MOPP . 16
4.2.110 WORKING VOLTAGE > 14 140 V peak . 17
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 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 . 55
4.2.152 Peak and RMS WORKING VOLTAGES . 56
4.2.153 Critical components . 57
4.2.154 LEAKAGE CURRENT test for ME EQUIPMENT with multiple APPLIED PARTS . 57
4.2.155 DIELECTRIC STRENGTH test value for extruded and spirally wrapped multi-
layer wires . 58
4.2.156 DIELECTRIC STRENGTH test after thermal cycling test . 58
4.2.157 Required MOOP values higher than MOPP values . 59
4.2.158 Optocouplers . 59
4.2.159 Impact test . 60
4.2.160 Spillage test in NORMAL CONDITION and in SINGLE FAULT CONDITION . 61
4.2.161 TYPE B APPLIED PART connected to ACCESSIBLE PARTS . 62
4.2.162 Current/power labeling . 62
4.2.163 Separate power supply part of ME EQUIPMENT or ME SYSTEM . 63
4.2.164 Specification of the allowed power supply . 63
4.2.165 Mains transients for opposite polarity on the secondary side or battery
pole to pole barrier . 64
4.2.166 Keep dry and umbrella symbol . 65
4.2.167 MOBILE and STATIONARY ME EQUIPMENT with wheels . 66
4.2.168 Varistors installed in the MAINS PART . 67
4.2.169 Using Y2 capacitors for MOPP . 67
4.2.170 Overtravel end stops – Specification of the speed. 68
4.2.171 CREEPAGE DISTANCE and AIR CLEARANCE between input and output of
fuse contacts . 69
4.2.172 Examples of SINGLE FAULT CONDITION . 70
4.2.173 Examples of ME SYSTEMS . 70
4.2.174 Cross sectional area of POWER SUPPLY CORD for rated input current
> 63 A . 71
4.2.175 Biocompatibility for quasi APPLIED PARTS . 71
4.2.176 Floating reference earth. 72
4.2.177 SINGLE FAULT CONDITION in OXYGEN RICH ENVIRONMENT . 73
4.2.178 Laser requirements . 75
4.2.179 Flammability rating of insulated wires . 75

– 4 – IEC TR 60601-4-3:2018  IEC 2018
4.2.180 Infrared lamps . 76
4.2.181 Identification of internal fuses . 77
4.2.182 Chargers for ME EQUIPMENT used at home . 78
4.2.183 CLASS II ME EQUIPMENT with FUNCTIONAL EARTH CONDUCTOR . 79
...

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 21 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - webstore.iec.ch/advsearchform IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: [e-mail].
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
...