IEC TR 62354:2009

IEC/TR 62354
®
Edition 2.0 2009-10
TECHNICAL
REPORT

General testing procedures for medical electrical equipment


IEC/TR 62354:2009(E)

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IEC/TR 62354
®
Edition 2.0 2009-10
TECHNICAL
REPORT

General testing procedures for medical electrical equipment


INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XH
ICS 11.040 ISBN 978-2-88910-682-0
® Registered trademark of the International Electrotechnical Commission

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– 2 – TR 62354 © IEC:2009(E)
CONTENTS
FOREWORD.5
INTRODUCTION.7
1 Scope and object.8
2 Normative references .8
3 Terms, definitions, abbreviations and acronyms .9
4 Types of tests.10
5 State of the ME EQUIPMENT .11
6 Number of samples .11
7 Applicable test items to the clauses of IEC 60601-1 .11
8 Sequence of tests.11
9 General testing condition.11
10 Power sources for tests .13
11 Measurement and test equipment.14
12 Treatments of unit symbols and measured values.16
13 PROCEDURES for testing, including particular conditions .17

Annex A (informative) Sequence of testing .157
Annex B (informative) Information typically required for product safety testing (Guide) . 160
Annex C (informative) Testing and measuring equipment. 162
Annex D (informative) Suitable measuring supply circuits . 163
Annex E (informative) Preventive maintenance . 166
Annex F (informative) Test probes .167
Annex G (informative) Index of tests (IEC 60601-1:2005 clauses order). 170
Annex H (informative) Index of tests for an INTERNALLY POWERED EQUIPMENT – battery
only – (IEC 60601-1:2005 clauses order) .172
Annex I (informative) Index of tests (IEC 60601-1:2005 alphabetic order) . 174
Annex J (informative) Index of tests for an INTERNALLY POWERED EQUIPMENT – battery
only – (IEC 60601-1:2005 alphabetic order) .176
Annex K (informative) Production line tests.178
Annex L (informative) Evaluation of the laboratory power source characteristics. 182
Annex M (informative) Traceability of calibrations and calibration intervals .187
Annex N (informative) Guidance for preparation, attachment, extension, use of

thermocouples and acceptance of thermocouple wire .189
Annex O (informative) Guideline for safe laboratory work. 194
Bibliography.201
Index of defined terms .203

Figure 1 – Area of the bottom of an ENCLOSURE as specified in 11.3 b) 1) .35
Figure 2 – Baffle .35
Figure 3 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 1 .50
Figure 4 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 2 .50
Figure 5 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 3 .50
Figure 6 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 4 .51

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TR 62354 © IEC:2009(E) – 3 –
Figure 7 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 5 .51
Figure 8 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 6 .51
Figure 9 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 7 .52
Figure 10 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 8 .52
Figure 11 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 9 .52
Figure 12 – Human body test mass.71
Figure 13 – Application of test voltage to bridged PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS.98
Figure 14 – Application of test voltage to individual PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS.99
Figure 15 – Application of test voltage to test the delivered defibrillation energy .102
Figure 16 – Example of a measuring device and its frequency characteristics. 104
Figure 17 – Measuring circuit for the EARTH LEAKAGE CURRENT of CLASS I equipment,
with or without APPLIED PARTS.106
Figure 18 – Measuring circuit for the TOUCH CURRENT.109
Figure 19 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT
CONNECTION to earth.111
Figure 20 – Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT
CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF
APPLIED PARTS or TYPE CF APPLIED PARTS) connected together. 112
Figure 21 – Measuring circuit for the PATIENT LEAKAGE CURRENT via the PATIENT
CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(S) .114
Figure 22 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a metal ACCESSIBLE PART that
is not PROTECTIVELY EARTHED .115
Figure 23 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART .117
Figure 24 – Measuring circuit for the PATIENT AUXILIARY CURRENT .119
Figure 25 – Ratio between HYDRAULIC TEST PRESSURE AND MAXIMUM PERMISSIBLE
WORKING PRESSURE .123
Figure 26 – Spark ignition test apparatus.130
Figure 27 – Maximum allowable current I as a function of the maximum allowable
voltage U measured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT .132
Figure 28 – Maximum allowable voltage U as a function of the capacitance C
measured in a capacitive circuit used in an OXYGEN RICH ENVIRONMENT .132
Figure 29 – Maximum allowable current I as a function of the inductance L measured in
an inductive circuit in an OXYGEN RICH ENVIRONMENT.133
Figure D.1 – Measuring supply circuit with one side of the SUPPLY MAINS at
approximately earth potential .163
Figure D.2 – Measuring supply circuit with SUPPLY MAINS approximately symmetrical to
earth potential.163
Figure D.3 – Measuring supply circuit for polyphase ME EQUIPMENT specified for
connection to a polyphase SUPPLY MAINS.163
Figure D.4 – Measuring supply circuit for single-phase ME EQUIPMENT specified for
connection to a polyphase SUPPLY MAINS.164
Figure D.5 – Measuring supply circuit for ME EQUIPMENT having a separate power
supply unit or intended to receive its power from another equipment in an ME SYSTEM.164
Figure F.1 – Standard test finger .167

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Figure F.2 – Test hook.168
Figure F.3 – Test pin.168
Figure F.4 – Ball-pressure test apparatus .169
Figure N.1 – Thermocouple preparation .189
Figure N.2 – Securing of thermocouples .190
Figure N.3 – Example of confinement of a thermocouple. 191
Figure N.4 – Example where thermocouple connectors need not be used . 192

Table 1 – Units outside the SI units system that may be used.17
Table 2 – Tests to be performed by inspection.18
Table 3 – NOMINAL cross-sectional area of conductors of a POWER SUPPLY CORD .29
Table 4 – Acceptable perforation of the bottom of an ENCLOSURE .36
Table 5 – Measurements and tests performed on non-energized equipment .39
Table 6 – Testing of cord anchorages .54
a
Table 7 – Acceptable gaps .60
Table 8 – Drop height .85
Table 9 – Test torques for rotating controls.91
Table 10 – Measurements and tests for equipment that is operating .92
Table 11 – Allowable maximum temperatures for skin contact with ME EQUIPMENT
APPLIED PARTS .140
Table 12 – Allowable maximum temperatures for ME EQUIPMENT parts that are likely to
be touched.140
Table 13 – Allowable maximum temperatures of parts. 141
Table 14 – Temperature limits of motor windings .141
Table 15 – Maximum motor winding steady-state temperature . 142
Table 16 – Maximum allowable temperatures of transformer windings under overload

and short-circuit conditions at 25 °C (± 5 °C) ambient temperature . 142
Table 17 – Test current for transformers .154
Table C.1 – IEC 60601-1:1988 + Amendment 1:1991 and Amendment 2:1995. 162
Table D.1 – Legends of symbols for Figures D.1 to D.5.165
Table L.1 – Method for testing a single phase laboratory power source .184

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TR 62354 © IEC:2009(E) – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

GENERAL TESTING PROCEDURES
FOR 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.
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 62354, 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.
This second edition cancels and replaces the first edition published in 2005. This edition
constitutes a technical revision. Several tests have been updated and additional test
procedures and informative annexes added.
This technical report is intended to be read in conjunction with IEC 60601-1:1988,
IEC 60601-1-1:2000 and IEC 60601-1:2005.

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The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/647/DTR 62A/669/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.
In this technical report, the terms defined in Clause 2 of IEC 60601-1:1988 or Clause 3 of
IEC 60601-1:2005 are printed in SMALL CAPITALS.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result 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.

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TR 62354 © IEC:2009(E) – 7 –
INTRODUCTION
IEC/TR 60513, Fundamental aspects of safety standards for medical electrical equipment
published by IEC sub-committee 62A provided the basis for inclusion of the test methods for
ME EQUIPMENT in the safety standards.
"Technical requirements and test methods are interrelated elements of product standards and
should always be considered together.
Product standards should identify where medically informed judgements are required in
deciding whether a particular requirement applies.
Wherever possible, the standards should contain test specifications for completely and clearly
checking compliance with the technical requirements. In some cases, a compliance statement
such as 'visual inspection', 'manual testing' or similar is adequate for this purpose if such a
method gives an accurate assessment.
It should be easy to recognize which test methods apply to each technical requirement.
Appropriate headings should designate the appropriate test and a reference should be made
to the clause containing the requirement. This also applies for references which are made to
other relevant test standards."
It was deemed necessary to support IEC 60601-1 with guidelines for general testing
PROCEDURES for MEDICAL ELECTRICAL EQUIPMENT.
In developing the test PROCEDURES, the advice given in IEC/TR 60513 and ISO/IEC Guide 51
was considered as follows:
a) test results should be reproducible within defined limits. When considered necessary, the
test method should incorporate a statement as to its limit of uncertainty;
b) where the sequence of tests can influence the results, the correct sequence should be
specified.
There is also growing support for the idea that all the test PROCEDURES for ME EQUIPMENT
should be found within one international standard.
ISO/IEC 17025, General requirements for the competence of testing and calibration
laboratories, highlights the need for a single series of requirements covering test
PROCEDURES.
IEC/TR 60513:1994 includes a major new principle referring to testing:
“In specifying minimum safety requirements, provision is made for assessing the
adequacy of the design PROCESS where this provides an appropriate alternative to the
application of laboratory testing with specific pass/fail criteria, (e.g. in assessing the
safety of new technologies such as programmable electronic systems).”

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GENERAL TESTING PROCEDURES
FOR MEDICAL ELECTRICAL EQUIPMENT



1 Scope and object
This technical report applies to MEDICAL ELECTRICAL EQUIPMENT (as defined in Subclauses 3.63
of IEC 60601-1:2005 and 2.2.15 of IEC 60601-1:1988), hereinafter referred to as
ME EQUIPMENT.
The object of this technical report is to provide guidance on general testing PROCEDURES
according to IEC 60601-1:1988, IEC 60601-1-1:2000 and IEC 60601-1:2005.
2 Normative references
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
IEC 60086-4:2000, Primary batteries – Part 4: Safety of lithium batteries
IEC 60127-1, Miniature fuses – Part 1: Definitions for miniature fuses and general
requirements for miniature fuse-links
IEC 60252-1, AC motor capacitors – Part 1: General – Performance, testing and rating –
Safety requirements – Guide for installation and operation
IEC 60364-4-41, Low voltage electrical installations – Part 4-41: Protection for safety –
Protection against electric shock
IEC 60417, Graphical symbols for use on equipment
IEC/TR 60513:1994, Fundamental aspects of safety standards for medical electrical
equipment
1)
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
Amendment 1: 1999
2)
IEC 60601-1: 1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1:1991
Amendment 2:1995
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety
– Collateral Standard: Safety requirements for medical electrical systems
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral Standard: Electromagnetic compatibility –
Requirements and tests
IEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control,
and laboratory use – Part 1: General requirements
—————————
1)
A consolidated version 2.1 (2001) exists that includes IEC 60529:1989 and its Amendment 1 (1999).
2)
The second edition of IEC 60601-1, canceled and replaced by the third edition in 2005.

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TR 62354 © IEC:2009(E) – 9 –
IEC 61672-1, Electroacoustics – Sound level meters – Part 1: Specifications
IEC 61672-2, Electroacoustics – Sound level meters – Part 2: Pattern evaluation tests
ISO 31 (all parts), Quantities and units
ISO 1000, SI units and recommendations for the use of their multiples and of certain other
units
ISO 11134, Sterilization of health care products – Requirements for validation and routine
3)
control – Industrial moist heat sterilization
4)

ISO 11135, Medical devices – Validation and routine control of ethylene oxide sterilization
ISO 11137, Sterilization of health care products – Requirements for validation and routine
5)

control – Radiation sterilization
6)
ISO 14971:2000, Medical devices – Application of risk management to medical devices
3 Terms, definitions, abbreviations and acronyms
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:1988 and
IEC 60601-1:2005 apply.
NOTE 1 Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. values of an
alternating, direct or composite voltage or current unless stated otherwise.
NOTE 2 An index of defined terms is found beginning on page 203.
NOTE 3 When used in the body of this document, N/A means “Not applicable”.
3.2 Abbreviations and acronyms
Abbreviation Term
a.c. Alternating current
d.c. Direct current
DUT Device under test
MAR Mean angle resolvable
MD Measuring device
ME MEDICAL ELECTRICAL
r.m.s. Root mean square
SI System international
SIP/SOP SIGNAL INPUT/OUTPUT PART
—————————
)
3
ISO 11134 was superseded by ISO 17665-1:2006, Sterilization of health care products – Moist heat – Part 1:
Requirements for the development, validation and routine control of a sterilization process for medical devices.
) ISO 11135 was replaced by ISO 11135-1:2007, Sterilization of health care products – Ethylene oxide – Part 1:
4
Requirements for development, validation and routine control of a sterilization process for medical devices.
)
5
ISO 11137 was replaced by ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1:
Requirements for development, validation and routine control of a sterilization process for medical devices.
6)
This first edition of ISO 14971 was replaced by a second edition in 2007.

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– 10 – TR 62354 © IEC:2009(E)
4 Types of tests
4.1 GENERAL
“TYPE TESTS” are required for verifying the BASIC SAFETY and ESSENTIAL PERFORMANCE of the
product design.
NOTE 1 The tests described in this technical report can also be used by the MANUFACTURER to ensure the quality
of the product and the manufacturing PROCESS. See A nne x I .
A test need not be carried out if analysis shows that the condition being tested has been
adequately evaluated by other tests or methods.
The results of the RISK ANALYSIS should additionally be used to determine which
combination(s) of simultaneous faults should be tested.
NOTE 2 The test results might render it necessary to revise the RISK ANALYSIS.
When testing the ME EQUIPMENT, relevant information provided by the MANUFACTURER in the
instruction for use sh
...