IEC TR 60601-4-3:2015
(Main)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
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.
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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
IEC TR 60601-4-3:2015-04(en)
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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
Warning! Make sure that you obtained this publication from an authorized distributor.
® Registered trademark of the International Electrotechnical Commission
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– 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
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IEC TR 60601-4-3:2015 IEC 2015 – 3 –
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
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3.2.179 Flammability rating of insulated wires . 74
3.2.180 Infrared lamps . 75
3.2.181 Identification of internal fuses . 76
3.2.182 Chargers for ME EQUIPMENT used at home . 77
3.2.183 CLASS II ME EQUIPMENT with FUNCTIONAL EARTH CONDUCTOR . 78
3.2.184 Symbol D2-2 on MSO . 78
3.2.185 PATIENT leads connectors . 79
3.2.186 Rationale for IP2X . 80
3.2.187 Battery – limited power . 80
3.2.188 TYPE B APPLIED PART separated from ACCESSIBLE PARTS . 81
3.2.189 Protective earth test >25A . 81
3.2.190 Reference to IEC 62304:2006 . 82
3.2.191 The SIP/SOP pin to earth TOUCH CURRENT . 82
3.2.192 Overbalancing . 84
3.2.193 MAINS VOLTAGE on APPLIED PART . 85
Annex A (informative) Overview of the recommendations developed by IEC/SC
62A/WG 14 . 86
Bibliography . 91
Table A.1 – Cross-reference of recommendations by subclause of IEC 60601-1:2005
and IEC 60601-1:2005/AMD1:2012 (1 of 5) . 86
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IEC TR 60601-4-3:2015 IEC 2015 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC TR 60601-4-3, which is a technical report, has been prepared by subcommittee 62A:
Common aspects of electrical equipment used in medical practice, of IEC technical committee
62: Electrical equipment in medical practice.
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The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/951/DTR 62A/973A/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
Terms used throughout this technical report that have been defined in Clause 3 of
IEC 60601-1:2005 and IEC 60601-1:2005/AMD 1:2012 are printed in SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this technical report may be issued at a later date.
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IEC TR 60601-4-3:2015 IEC 2015 – 7 –
INTRODUCTION
At the Sydney meeting in August 1994, IEC subcommittee (SC) 62A established a procedure
under which working group (WG) 14 would develop recommendations regarding problems of
interpretation or application of IEC 60601-1. WG 14 is made up of experts with particular
expertise in testing according to the requirements of IEC 60601-1. Many of the experts on
WG 14 are employed by test laboratories with a long history of applying IEC 60601-1 to
MEDICAL ELECTRICAL EQUIPMENT. While the National Committee members of SC 62A nominate
these experts, their recommendations were not to be formally adopted through any official
voting procedure. To reinforce this process, the Subcommittee specifically directed that the
following note appear on every page of the resulting informational circular:
IMPORTANT NOTE: Per the 62A decision at Sydney (see RM3755/SC62A, August 1994), the
62A Secretary is circulating this recommendation, prepared by 62A/WG 14, regarding
problems of interpretation or application of IEC 60601-1 to all P-Member NCs.
This recommendation/interpretation is the result of considerations by a group of nominated
experts and has not been formally adopted through any National Committee voting procedure.
Distribution is only for information.
At the November 2000 meeting of SC 62A in Tokyo, the subcommittee discussed ways and
means for achieving a wider distribution of the WG 14 recommendations. At the conclusion of
this discussion, the subcommittee instructed the Secretariat to develop a technical report (TR)
based on the published recommendations of WG 14. This technical report 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 of IEC TR 60601-4-3 contains 93 recommendations, numbered 101 to 193.
All these recommendations are based upon IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012.
The numbering starts with 101 instead of just 1 to ensure that these WG 14 recommendations
(101 to 193) will not accidentally be confused with previous issued WG 14 recommendations 1
to 63, which are based on the second edition of IEC 60601-1 and published in IEC TR 62296.
This technical report may be amended from time to time as WG 14 prepares additional
recommendations.
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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
1 Scope and object
1.1 Scope
This technical report contains a series of recommendations developed by an expert working
group of IEC subcommittee 62A in response to questions of interpretation of the third edition
of IEC 60601-1.
This technical report 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 and IEC 60601-1:2005/AMD1:2012, and
– 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 a future revision of IEC 60601-1.
1.2 Object
The object of this technical report is to make the recommendations/interpretations developed
by the experts in IEC/SC 62A/WG 14 available to those interested in the application of the
third edition of IEC 60601-1.
The reader is reminded that, although a majority of the National Committee members of IEC/SC 62A have
approved publication of this technical report, the contents remain the opinion of the expert members of WG 14.
These recommendations/interpretations are the result of considerations by this group of nominated experts and
have not been formally adopted through any National Committee voting procedure. Distribution is only for
information.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-11:2010, Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
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IEC TR 60601-4-3:2015 IEC 2015 – 9 –
3 Recommendations
3.1 Template used for recommendations prepared by SC 62A/WG 14
The recommendations in this Technical Report are presented in tabular form using the
following table structure.
a)
WG 14 recommendation number
NNN
b)
Requirement, clause/ subclause number(s)
c)
Source/problem
d)
Discussion/comment
e)
Submitter proposed recommendation
f)
WG 14 recommendation
a)
The numbering of the recommendations in the Technical Report starts with 101 instead of just 1 to ensure
that these WG 14 recommendations will not accidentally be confused with previously issued WG 14
recommendations 1 to 63, which are based on the second edition of IEC 60601-1.
b)
The clause, subclause or requirement to which the question is related. If no standard is listed, the reference
is to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
c)
A description of the problem as submitted to WG 14.
d)
Additional discussion or commentary provided by the submitter.
e)
The submitter's proposed resolution to the problem, if one exists.
f)
The final recommendation developed by WG 14.
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3.2 Recommendation sheets
3.2.101 Total PATIENT LEAKAGE CURRENT of a ME SYSTEM
WG 14 recommendation number 101
Requirement, clause/ subclause 16.6.3
number(s)
Source/problem There is no measuring circuit or measurement method given in
IEC 60601-1 for measurement of the total PATIENT LEAKAGE CURRENT
of ME SYSTEMS.
Input: PATIENT can be simultaneously monitored for a physiological
parameter by the ME EQUIPMENT “1” and for other physiological
parameter by the ME EQUIPMENT “2”. The ME EQUIPMENT “1” and “2”
belong to the same ME SYSTEM. The total PATIENT LEAKAGE CURRENT
of the ME SYSTEM in question should be measured, but how should
the measurement be performed?
Discussion/comment –
Submitter proposed recommendation –
WG 14 recommendation Q1:
Shall the total PATIENT LEAKAGE CURRENT of the ME SYSTEM be
measured “from” and “to” all PATIENT CONNECTIONS of all APPLIED
PARTS (in the ME SYSTEM) of the same type connected together?
NOTE Those APPLIED PARTS belong to several individual
ME EQUIPMENTS of the ME SYSTEM.
WG 14 answer to Q1:
No, measure only “from” (i.e. to earth) not “to” all PATI
...
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