SIST EN 62353:2014

SLOVENSKI STANDARD
01-december-2014
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SIST EN 62353:2008
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Medical electrical equipment - Recurrent test and test after repair of medical electrical
equipment
Medizinische elektrische Geräte - Wiederholungsprüfungen und Prüfung nach
Instandsetzung von medizinischen elektrischen Geräten
Appareils électromédicaux – Essai récurrent et essai après réparation d’un appareil
électromédical
Ta slovenski standard je istoveten z: EN 62353:2014
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 62353
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040 Supersedes EN 62353:2008
English Version
Medical electrical equipment - Recurrent test and test after repair
of medical electrical equipment
(IEC 62353:2014)
Appareils électromédicaux - Essai récurrent et essai après Medizinische elektrische Geräte - Wiederholungsprüfungen
réparation d'un appareil électromédical und Prüfung nach Instandsetzung von medizinischen
(CEI 62353:2014) elektrischen Geräten
(IEC 62353:2014)
This European Standard was approved by CENELEC on 2014-10-09. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62353:2014 E
Foreword
The text of document 62A/942/FDIS, future edition 2 of IEC 62353 prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be (dop) 2015-07-09
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2017-10-09
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 62353:2008.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
Endorsement notice
The text of the International Standard IEC 62353:2014 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:

IEC 60335 Series NOTE Harmonized as EN 60335 Series.
IEC 60950 Series NOTE Harmonized as EN 60950 Series.
IEC 60950-1 NOTE Harmonized as EN 60950-1.
IEC 61010 Series NOTE Harmonized as EN 61010 Series.
IEC 61557-2:2007 NOTE Harmonized as EN 61557-2:2007 (not modified).
IEC 61557-4:2007 NOTE Harmonized as EN 61557-4:2007 (not modified).
1) 1)
IEC 61557-16 NOTE Harmonized as EN 61557-16 (not modified).
IEC 62020 NOTE Harmonized as EN 62020.
ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012 (not modified).
ISO 14971:2007 NOTE Harmonized as EN ISO 14971:2012 (not modified).
IEC 60364-7-710 NOTE Harmonized as HD 60364-7-710.
IEC 61010-2-010 NOTE Harmonized as EN 61010-2-010.

1)
To be published.
- 3 - EN 62353:2014
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu
Publication Year Title EN/HD Year

IEC 60417-DB -  Graphical symbols for use on equipment - -
IEC 60601-1 1988 Medical electrical equipment - EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
+ A1 1991 + A1 1993
+ A1/corr. July 1994
+ A2 1995 + A2 1995
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance + corr. May 2014
+A1 2012 + A1 2013
+ A1/corr. July 2014
IEC 61010-1 -  Safety requirements for electrical EN 61010-1 -
equipment for measurement, control and
laboratory use -
Part 1: General requirements
IEC 61010-031 -  Safety requirements for electrical EN 61010-031 -
equipment for measurement, control
and laboratory use -
Part 031: Safety requirements for hand-
held probe assemblies for electrical
measurement and test
IEC 61140 -  Protection against electric shock - EN 61140 -
Common aspects for installation and
equipment
IEC 61557-1 -  Electrical safety in low voltage distribution EN 61557-1 -
systems up to 1 000 V a.c. and 1 500 V
d.c. - Equipment for testing, measuring or
monitoring of protective measures -
Part 1: General requirements
IEC 62353 ®
Edition 2.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment – Recurrent test and test after repair of medical

electrical equipment
Appareils électromédicaux – Essai récurrent et essai après réparation d’un

appareil électromédical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040 ISBN 978-2-8322-1847-1

– 2 – IEC 62353:2014 © IEC 2014
CONTENTS
FOREWORD . 5
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 8
4 Requirements . 16
4.1 * General requirements . 16
4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR . 17
4.3 * RECURRENT TEST . 18
5 * Tests . 18
5.1 General . 18
5.2 Visual INSPECTION . 18
5.3 Measurements . 19
5.3.1 General . 19
5.3.2 Measuring of PROTECTIVE EARTH RESISTANCE . 19
5.3.3 * Measurement of insulation resistance (not mandatory) . 21
5.3.4 Leakage currents . 24
5.4 Functional test . 31
6 Results of test and evaluation . 31
6.1 Reporting of results. 31
6.2 Evaluation . 32
Annex A (informative) General guidance and rationale . 33
A.1 Intended audience . 33
A.2 Differences between IEC 60601-1 and IEC 62353 . 34
A.3 Rationale . 35
Annex B (informative) Sequence of testing . 42
Annex C (normative) Requirements for the measurement equipment and for
measurement circuits for PROTECTIVE EARTH RESISTANCE and leakage currents . 44
C.1 Requirements for the measurement equipment . 44
C.2 Measurement equipment for measurement of PROTECTIVE EARTH RESISTANCE . 44
C.3 Measurement equipment for measurements of EQUIPMENT LEAKAGE CURRENT . 45
C.4 Measurement equipment for measurements of APPLIED PART LEAKAGE
CURRENT . 45
Annex D (informative) PATIENT ENVIRONMENT . 47
Annex E (normative) Allowable values for leakage currents from IEC 60601-1 . 48
Annex F (informative) Testing intervals . 51
Annex G (informative) Example of test documentation . 52
Annex H (informative) Notes on testing ME SYSTEMS . 53
H.1 Overview . 53
H.2 Guidelines for re-testing of an ME SYSTEM . 53
H.3 Guidelines on ME SYSTEMS from the rationale annex of IEC 60601-
1:2005 /AMD1:2012 . 54
H.4 Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) . 58
Bibliography . 60
Index of defined terms . 61

IEC 62353:2014 © IEC 2014 – 3 –
Figure 1 – Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in
ME EQUIPMENT that is disconnected from the SUPPLY MAINS . 20
Figure 2 – Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in
ME EQUIPMENT or ME SYSTEMS, which for functional reasons cannot be disconnected
from the SUPPLY MAINS, or in ME EQUIPMENT or ME SYSTEMS permanently connected to
the SUPPLY MAINS . 20
Figure 3 – Measuring circuit for the measurement of the insulation resistance between
MAINS PART and protective earth for CLASS I ME EQUIPMENT and between MAINS PART and
(non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II ME EQUIPMENT . 22
Figure 4 – Measuring circuit for measurement of the insulation resistance between
MAINS PART and APPLIED PARTS which make a patient connection for CLASS I or CLASS II
ME EQUIPMENT . 23
Figure 5 – Measuring circuit for measurement of the insulation resistance between F-
TYPE APPLIED PARTS which make a patient connection and protective earth for CLASS I
ME EQUIPMENT and between F-TYPE APPLIED PARTS which make a patient connection and
(non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II ME EQUIPMENT . 23
Figure 6 – Measuring circuit for the measurement of ME EQUIPMENT leakage current –
alternative method . 26
Figure 7 – Measuring circuit for the measurement of EQUIPMENT LEAKAGE CURRENT–
direct method . 27
Figure 8 – Measuring circuit for the measurement EQUIPMENT LEAKAGE CURRENT–
differential method . 28
Figure 9 – Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT “F-
TYPE APPLIED PART” – alternative method . 29
Figure 10 – Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT –
MAINS VOLTAGE on F-TYPE APPLIED PART – direct method . 30
Figure 11 – Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT
for equipment with an INTERNAL ELECTRICAL POWER SOURCE – direct method . 30
Figure A.1 – CLASS I ME EQUIPMENT with no earthed ACCESSIBLE CONDUCTIVE PARTS of
the enclosure . 37
Figure A.2 – Plugged-in CLASS I ME EQUIPMENT . 37
Figure A.3 – Plugged-in CLASS II ME EQUIPMENT . 38
Figure A.4 – Plugged-in CLASS I ME EQUIPMENT with mains on the APPLIED PART . 38
Figure A.5 – Plugged-in CLASS II ME EQUIPMENT with mains on the APPLIED PART . 39
Figure B.1 – Sequence of testing . 42
Figure B.2 – Measurement of LEAKAGE CURRENTS (non-PERMANENTLY INSTALLED
CLASS I ME EQUIPMENT) . 43
Figure C.1 – Example of a measuring device and its frequency characteristics . 46
Figure D.1 – Example of PATIENT ENVIRONMENT . 47
Figure G.1 – Example of test documentation . 52
Figure H.1 – Example of the construction of a MULTIPLE SOCKET-OUTLET (MSO)
(accessible only with the use of a tool). 58
Figure H 2 – Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) . 59

Table 1 – Legends of symbols . 21
Table 2 – Insulation resistance values . 24
Table 3 – Allowable values for leakage currents . 31
Table A.1 – Addressees and their possible interest in this standard . 33
Table A.2 – Reasons for choosing different measuring methods . 40

– 4 – IEC 62353:2014 © IEC 2014
Table E.1 – Allowable values for continuous leakage currents from IEC 60601-1:1988 . 48
Table E.2 – Allowable values for TOUCH CURRENTS, EARTH LEAKAGE CURRENTS, PATIENT
LEAKAGE CURRENTS and patient auxiliary currents under NORMAL CONDITION and SINGLE
FAULT CONDITION from IEC 60601-1:2005 . 49
Table E.3 – Allowable values for PATIENT LEAKAGE CURRENTS under the special test
conditions identified in 8.7.4.7 of IEC 60601-1:2005 . 50

Table H.1 – Some examples of ME SYSTEMS for illustration . 56

IEC 62353:2014 © IEC 2014 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
RECURRENT TEST AND TEST AFTER REPAIR
OF MEDICAL ELECTRICAL EQUIPMENT

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,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
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
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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.
International Standard IEC 62353 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.
This second edition cancels and replaces the first edition of IEC 62353 published in 2007.
This edition constitutes a technical revision. The principle revisions are:
a) clarification in 5.3.4.1 that measurements of leakage currents based on test configurations
derived from IEC 60601-1 are an allowable alternative method and the inclusion of
informative explanation in Annex A;
b) revision of the PROTECTIVE EARTH RESISTANCE requirements for MEDICAL ELECTRICAL
SYSTEMS using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on
the safe allowed values of protective earth resistance of plugged-in equipment;
c) the inclusion of expected minimum insulation resistance values in Table 2; and
d) a reordering of the sequence of testing in Annex B.

– 6 – IEC 62353:2014 © IEC 2014
The text of this standard is based on the following documents:
FDIS Report on voting
62A/942/FDIS 62A/953/RVD
Full information on the voting for the approval of this standard 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.
In this standard, the following print types are used:
– requirements and definitions: roman type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3: IN SMALL
CAPITALS.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex A.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site 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.
NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
IEC 62353:2014 © IEC 2014 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
RECURRENT TEST AND TEST AFTER REPAIR
OF MEDICAL ELECTRICAL EQUIPMENT

1 Scope
This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such
equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its
amendments and IEC 60601-1: 2005 (third edition) and its amendments, before PUTTING INTO
SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of
RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof.
For equipment not built to IEC 60601-1 these requirements may be used taking into account
the safety standards for the design and information in the instructions for use of that
equipment.
This standard contains tables with allowable values relating to different editions of
IEC 60601-1. For the purpose of this standard, the application of measuring methods is
independent of the edition according to which the ME EQUIPMENT or ME SYSTEM is designed.
This standard contains:
– "general requirements", which contain clauses of general concern, and
– "particular requirements", further clauses handling special types of ME EQUIPMENT or
ME SYSTEMS and applying in connection with the "General requirements".
NOTE At this stage, there are no particular requirements.
This standard is not suitable to assess whether ME EQUIPMENT or ME SYSTEMS or any other
equipment comply with the relevant standards for their design.
This standard is not applicable to the assembly of ME SYSTEMS. For assembling ME SYSTEMS
see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012 .
This standard does not define requirements for REPAIR, exchange of components and
MODIFICATION of ME EQUIPMENT or ME SYSTEMS.
All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with
MANUFACTURER's instructions maintain the conformity to the standard used for the design of
the equipment. Otherwise conformity to applicable requirements should be assessed and
verified, before the tests of this standard are performed.
This standard is also applicable to tests after REPAIR.
IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012 requires that, as part of the RISK
MANAGEMENT PROCESS, the MANUFACTURER considers how the safety of ME EQUIPMENT or an
ME SYSTEM can be ensured during product lifetime. As part of the risk management process
the MANUFACTURER may have identified MAINTENANCE procedures. This includes defining the
respective tests for ME EQUIPMENT or for ME SYSTEM.
_______________
This citation refers to IEC 60601-1:2005 as amended by Amendment 1 published in 2012.

– 8 – IEC 62353:2014 © IEC 2014
The MANUFACTURER may have defined necessary measurement settings and methods
including performance assurance tests in the instructions for use or other ACCOMPANYING
DOCUMENTS. This standard provides consistent test procedures.
This standard is not intended to define time intervals for RECURRENT TESTS. If such intervals
are not defined by the MANUFACTURER, Annex F can be used to help establish such intervals.
Testing of the electrical installation, including the SUPPLY MAINS and associated wiring, in
medical locations is excluded from this standard. Such tests are covered by IEC 60364-7-710
or national equivalents,
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 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
IEC 60601-1:1988/AMD1:1991
IEC 60601-1:1988/AMD 2:1995
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60417, Graphical symbols for use on equipment. Available from: symbols.info/equipment>
IEC 61010-1, Safety requirements for electrical equipment for measurement, control and
laboratory use – Part 1: General requirements
IEC 61010-031, Safety requirements for electrical equipment for measurement, control and
laboratory use – Part 031: Safety requirements for hand-held probe assemblies for electrical
measurement and test
IEC 61140, Protection against electric shock – Common aspects for installation and
equipment
IEC 61557-1, Electrical safety in low voltage distribution systems up to 1 000 V a.c. and
1 500 V d.c. – Equipment for testing, measuring or monitoring of protective measures –
Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE Some of the definitions are necessarily different from those in IEC 60601-1, as different measuring
methods are used.
_______________
There exists a consolidated edition 3.1 including IEC 60601-1:2005 and its Amendment 1 (2012).

IEC 62353:2014 © IEC 2014 – 9 –
3.1
ACCESSIBLE CONDUCTIVE PART
an electrically conductive part of the ME EQUIPMENT other than an APPLIED PART, which is
accessible to the patient or to the operator in contact with the patient or can come in contact
with the patient
3.2
ACCESSORY
additional part for use with equipment in order to:
– achieve the intended use,
– adapt it to some special use,
– facilitate its use,
– enhance its performance, or
– enable its functions to be integrated with those of other equipmentt
[SOURCE: IEC 60601-1:2005, 3.3]
3.3
ACCOMPANYING DOCUMENT
document accompanying ME EQUIPMENT, an ME SYSTEM, equipment or an ACCESSORY and
containing information for the RESPONSIBLE ORGANIZATION or operator, particularly regarding
basic safety and essential performance
[SOURCE: IEC 60601-1:2005, 3.4]
3.4
APPLIED PART
part of ME EQUIPMENT that in normal use necessarily comes into physical contact with the
patient for ME EQUIPMENT or an ME SYSTEM to perform its function
[SOURCE: IEC 60601-1:2005, 3.8, modified – The notes in the original definition have been
deleted because they were only internally relevant to the source document.]
3.5
APPLIED PART LEAKAGE CURRENT
current flowing between an F-TYPE APPLIED PART and all of the following as applicable:
− MAIN PARTS and
− ACCESSIBLE CONDUCTIVE PARTS of the enclosure;
caused by an external voltage on the F-TYPE APPLIED PART.
3.6
CLASS I
term referring to electrical equipment in which protection against electric shock does not rely
on basic insulation only, but which includes an additional safety precaution in that means are
provided for accessible parts of metal or internal parts of metal to be protectively earthed
[SOURCE: IEC 60601-1:2005, 3.13]
3.7
CLASS II
term referring to electrical equipment in which protection against electric shock does not rely
on basic insulation only, but in which additional safety precautions such as double insulation
or reinforced insulation are provided, there being no provision for protective earthing or
reliance upon installation conditions

– 10 – IEC 62353:2014 © IEC 2014
Note 1 to entry: CLASS II ME EQUIPMENT can be provided with a functional earth terminal or a functional earth
conductor.
[SOURCE: IEC 60601-1:2005, 3.14]
3.8
CONFIGURATION
term that refers to software settings or hardware settings of ME EQUIPMENT, or the
arrangement and interconnection of ME EQUIPMENT and any other equipment that form an
ME SYSTEM, that are appropriate for an intended clinical application
3.9
DETACHABLE POWER SUPPLY CORD
flexible cord intended to be connected to electrical equipment by means of a suitable
appliance coupler for mains supply purposes
[SOURCE: IEC 60601-1:2005, 3.21]
3.10
EARTH LEAKAGE CURRENT
current flowing from the MAINS PART through or across the insulation into the PROTECTIVE
EARTH CONDUCTOR
[SOURCE: IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012, 3.25, modified – Reference to
the functional earth connection removed.]
3.11
ELECTRICAL SAFETY
status of protective measures within an equipment/system designed and produced in
accordance with IEC 60601-1 which limit the effects of electrical current on a patient, user or
other individuals in accordance with this standard
Note 1 to entry: Safety is defined as freedom from unacceptable risk (refer to ISO 14971:2007, definition 2.24).
3.12
EQUIPMENT LEAKAGE CURRENT
total current flowing from MAINS PARTS to earth via
a) the PROTECTIVE EARTH CONDUCTOR and ACCESSIBLE CONDUCTIVE PARTS of the enclosure and
APPLIED PARTS (differential and alternative method), or
b) the ACCESSIBLE CONDUCTIVE PARTS of the enclosure and APPLIED PARTS (direct method)
3.13
F-TYPE ISOLATED (FLOATING) APPLIED PART (herein F-TYPE APPLIED PART)
APPLIED PART in which the patient connections are isolated from other parts of the
ME EQUIPMENT to such a degree that no current higher than the allowable PATIENT LEAKAGE
CURRENT flows if an unintended voltage originating from an external source is connected to
the patient, and thereby applied between the patient connection and earth
Note 1 to entry: F-TYPE APPLIED PARTS are either TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS.
[SOURCE: IEC 60601-1:2005, 3.29]
3.14
FUNCTIONAL CONNECTION
connection, electrical or otherwise, including those intended to transfer signals, data, power
or substances
IEC 62353:2014 © IEC 2014 – 11 –
Note 1 to entry: Connection to a fixed SUPPLY MAINS socket-outlet, whether single or multiple, is not considered to
result in a FUNCTIONAL CONNECTION.
[SOURCE: IEC 60601-1:2005, 3.33]
3.15
INSPECTION
combination of all means for verification and assessment of a status quo
3.16
INTERNAL ELECTRICAL POWER SOURCE
electrical power source for operating equipment that is a part of the equipment and which
produces electrical current from some other form of energy
EXAMPLE Chemical, mechanical, solar, or nuclear
Note 1 to entry: An INTERNAL ELECTRICAL POWER SOURCE can be inside the principal part of equipment, attached to
the outside, or contained in a separate enclosure.
[SOURCE: IEC 60601-1:2005, 3.45]
3.17
LINE-TO-EARTH VOLTAGE
voltage between a line conductor and earth/ground.
[SOURCE: IEC 60050-195:1998, 195-05-03, modified – Replaced "reference earth at a given
point of an electrical circuit" with "earth/ground".]
3.18
MAINS PART
part of electrical equipment forming a circuit that is intended to be connected to the SUPPLY
MAINS
Note 1 to entry: The MAINS PART includes all conductive parts that are not separated from the SUPPLY MAINS by at
least one means of protection.
Note 2 to entry: For the purpose of this definition, the PROTECTIVE EARTH CONDUCTOR is not regarded as a part of
the MAINS PART.
[SOURCE: IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012, 3.49]
3.19
MAINS PLUG
part, integral with or intended to be attached to a POWER SUPPLY CORD of electrical equipment,
to be inserted into a mains socket-outlet
[SOURCE: IEC 60601-1:2005, 3.50, modified – A note referring to IEC 60083 and
IEC 60309-1 has been deleted.]
3.20
MAINS VOLTAGE
voltage of a SUPPLY MAINS between two line conductors of a polyphase system or voltage
between the line conductor and the neutral conductor of a single-phase system
[SOURCE: IEC 60601-1:2005, 3.54]

– 12 – IEC 62353:2014 © IEC 2014
3.21
MAINTENANCE
combination of all technical and administrative means, including supervisory ones, to keep
ME EQUIPMENT or an ME SYSTEM in a normal working condition or restored to normal working
condition
3.22
MANUFACTURER
natural or legal person with responsibility for the design, manufacture, packaging, or labelling
of ME EQUIPMENT, assembling an ME SYSTEM, or adapting ME EQUIPMENT or an ME SYSTEM,
regardless of whether these operations are performed by that person or on that person's
behalf by a third party
Note 1 to entry: ISO 13485 [9] defines “labelling” as written, printed or graphic matter
• affixed to a medical device or any of its containers or wrappers, or
• accompanying a medical device,
related to identification, technical description and use of the medical device, but excluding shipping documents. In
this standard, that material is described as markings and ACCOMPANYING DOCUMENTS.
Note 2 to entry: ‟Adapting” includes making substantial MODIFICATIONS to ME EQUIPMENT or an ME SYSTEM already
in use.
Note 3 to entry: In some jurisdictions, the RESPONSIBLE ORGANIZATION can be considered a MANUFACTURER when
involved in the activities described.
Note 4 to entry: Adapted from ISO 14971:2007 [10], definition 2.8.
[SOURCE: IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012, 3.55]
3.23
MEDICAL ELECTRICAL EQUIPMENT
ME EQUIPMENT
electrical equipment having an APPLIED PART or transferring energy to or from the patient or
detecting such energy transfer to or from the patient and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS, and
b) intended by its MANUFACTURER to be used:
– in the diagnosis, treatment, or monitoring of a patient, or
– for compensation or alleviation of disease, injury or disability
Note 1 to entry: ME EQUIPMENT includes those ACCESSORIES as defined by the MANUFACTURER that are necessary
to enable the normal use of the ME EQUIPMENT.
Note 2 to entry: Not all electrical equipment used in medical practice falls within this definition (e.g. some in vitro
diagnostic equipment).
Note 3 to entry: The implantable parts of active implantable medical devices can fall within this definition, but they
are excluded from the scope of IEC 60601-1.
[SOURCE: IEC 60601-1:2005, 3.63, modified – Two notes in the original definition have been
deleted because they were only internally relevant to the source document. ]
3.24
MEDICAL ELECTRICAL SYSTEM (ME SYSTEM)
combination, as specified by its MANUFACTURER, of items of equipment, at least one of which
is ME EQUIPMENT to be inter-connected by FUNCTIONAL CONNECTION or by use of a MULTIPLE
SOCKET-OUTLET
_______________
Numbers in square brackets refer to the Bibliography.

IEC 62353:2014 © IEC 2014 – 13 –
Note 1 to entry: Equipment, when mentioned in this standard, should be taken to include ME EQUIPMENT.
Note 2 to entry: ME SYSTEM includes those ACCESSORIES as defined by the MANUFACTURER that are necessary to
enable the normal use of the ME SYSTEM.
[SOURCE: IEC 60601-1:2005, 3.64, modified – A second note to entry has been added.]
3.25
MODIFICATION
changing constructional or functional features of ME EQUIPMENT or an ME SYSTEM in a way not
described in its ACCOMPANYING DOCUMENTS
Note 1 to entry: This definition should not be confused with “change of ACCESSORIES” because the latter means
changing of ME EQUIPMENT or ME SYSTEMs in a way described in its ACCOMPANYING DOCUMENTS.
3.26
MULTIPLE SOCKET-OUTLET
MSO
one or more socket-outlets intended to be connected to, or integral with, flexible cables, cords
or ME EQUIPMENT providing SUPPLY MAINS or equivalent voltage
Note 1 to entry: A MULTIPLE SOCKET-OUTLET can be a separate item or an integral part of equipment.
[SOURCE: IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012, 3.67]
3.27
NON-DETACHABLE POWER SUPPLY CORD
POWER SUPPLY CORD fixed to equipment
3.28
NORMAL CONDITION
condition in which all means provided for protection against hazards are intact
[SOURCE: IEC 60601-1:2005, 3.70]
3.29
PATIENT ENVIRONMENT
any volume in which intentional or unintentional contact can occur between a patient and
parts of the ME EQUIPMENT or ME SYSTEM or between a patient and other persons touching
parts of the ME EQUIPMENT or ME SYSTEM
Note 1 to entry: It is difficult to define dimensions for the volume in which diagnosis, monitoring or treatment
occurs. The dimensions for the PATIENT ENVIRONMENT given in Figure D.1 have been justified in practice.
[SOURCE: IEC 60601-1:2005, 3.79, modified – A note to entry has been added.]
3.30
PATIENT LEAKAGE CURRENT
current:
– flowing from the PATIENT CONNECTIONS via the PATIENT to earth, or
– originating from the unintended appearance of a voltage from an external source on the
PATIENT and flowing from the PATIENT via the PATIENT CONNECTIONS of an F-TYPE APPLIED
PART to earth
[SOURCE: IEC 60601-1:2005, 3.80]
3.31
PERMANENTLY INSTALLED
term meaning electrically connected to the SUPPLY MAINS by means of a permanent connection
that can only be detached by the use of a tool

– 14 – IEC 62353:2014 © IEC 2014
[SOURCE: IEC 60601-1:2005, 3.84]
3.32
POWER SUPPLY CORD
flexible cord, fixed to or assembled with electrical equipment for connection to SUPPLY MAINS
[SOURCE: IEC 60601-1:2005, 3.87]
3.33
PROTECTIVE EARTH CONDUCTOR
conductor to be connected between the PROTECTIVE EARTH TERMINAL and an external
protective earthing system
[SOURCE: IEC 60601-1:2005, 3.93]
3.34
PROTECTIVE EARTH RESISTANCE
resistance between any ACCESSIBLE CONDUCTIVE PART which has to be connected for safety
purposes to the PROTECTIVE EARTH TERMINAL and the
− protective connector of the MAINS PLUG, or
− protective connector of the appliance inlet, or
− protective conductor permanently connected to the SUPPLY MAINS;
DETACHABLE POWER SUPPLY CORD
resistance between protective connectors at each end of a
3.35
PROTECTIVE EARTH TERMINAL
terminal connected to conductive parts of CLASS I equipment for safety purposes. This terminal
is intended to be connected to an external protective earthing system by a PROTECTIVE EARTH
CONDUCTOR
[SOURCE: IEC 60601-1:2005, 3.95]
3.36
PUTTING INTO SERVICE
first use of the ME EQUIPMENT or ME SYSTEM after setting up at the RESPONSIBLE ORGANIZATION
Note 1 to entry: This may be the first application of RECURRENT TESTS.
3.
...