IEC 61558-2-15:2022
(Main)Safety of transformers, reactors, power supply units and combinations thereof - Part 2-15: Particular requirements and tests for isolating transformers for medical IT systems for the supply of medical locations
Safety of transformers, reactors, power supply units and combinations thereof - Part 2-15: Particular requirements and tests for isolating transformers for medical IT systems for the supply of medical locations
IEC 61558-2-15:2022 deals with safety of isolating transformers for medical IT systems for the supply of medical locations. This third edition cancels and replaces the second edition published in 2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- Adjustment of structure and references in accordance with IEC 61558-1:2017.
It has the status of a group safety publication in accordance with IEC Guide 104.
Sécurité des transformateurs, bobines d’inductance, blocs d'alimentation et des combinaisons de ces éléments - Partie 2-15: Exigences particulières et essais pour les transformateurs de séparation de circuits pour schémas IT médicaux pour l'alimentation des locaux à usages médicaux
L'IEC 61558-2-15:2022 traite de la sécurité des transformateurs de séparation de circuits pour schémas IT médicaux pour l’alimentation des locaux à usages médicaux. Cette troisième édition annule et remplace la deuxième édition parue en 2011. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
- Ajustement de la structure et des références conformément à l'IEC 61558-1:2017.
Il a le statut de publication groupée de sécurité conformément au Guide IEC 104.
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IEC 61558-2-15 ®
Edition 3.0 2022-05
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GROUP SAFETY PUBLICATION
Safety of transformers, reactors, power supply units and combinations thereof –
Part 2-15: Particular requirements and tests for isolating transformers
for medical IT systems for the supply of medical locations
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International Standards for all electrical, electronic and related technologies.
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IEC 61558-2-15 ®
Edition 3.0 2022-05
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
GROUP SAFETY PUBLICATION
Safety of transformers, reactors, power supply units and combinations thereof –
Part 2-15: Particular requirements and tests for isolating transformers
for medical IT systems for the supply of medical locations
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 29.180 ISBN 978-2-8322-5041-9
– 2 – IEC 61558-2-15:2022 RLV © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
1 Scope . 8
2 Normative references . 9
3 Terms and definitions . 9
4 General requirements . 10
5 General notes on tests . 10
6 Ratings . 10
7 Classification . 11
8 Marking and other information . 11
9 Protection against electric shock . 12
10 Change of input voltage setting . 13
11 Output voltage and output current under load . 13
12 No-load output voltage . 13
13 Short-circuit voltage . 13
14 Heating . 14
15 Short-circuit and overload protection . 15
16 Mechanical strength . 15
17 Protection against harmful ingress of dust, solid objects and moisture . 15
18 Insulation resistance, dielectric strength and leakage current . 15
19 Construction . 18
20 Components . 20
21 Internal wiring . 20
22 Supply connection and other external flexible cable or cords . 20
23 Terminals for external conductors . 21
24 Provisions for protective earthing. 21
25 Screws and connections . 21
26 Creepage distances, clearances and distances through insulation . 21
27 Resistance to heat, fire and tracking . 21
28 Resistance to rusting . 21
Annexes . 22
Annex H (normative) Electronic circuits . 22
Annex L (normative) Routine tests (production tests) . 22
Bibliography . 23
Index of defined terms .
Figure 101 – Required circuit for measuring the leakage current from the output
winding to the earthing . 17
Figure 102 – Required circuit for measuring the leakage current at the protective
earthing conductor . 18
Table 101 – Symbols indicating the kind of transformer . 12
Table 102 – Additional dielectric strength test voltages . 16
– 4 – IEC 61558-2-15:2022 RLV © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY OF TRANSFORMERS, REACTORS,
POWER SUPPLY UNITS AND COMBINATIONS THEREOF –
Part 2-15: Particular requirements and tests for isolating transformers
for medical IT systems for the supply of medical locations
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.
This redline version of the official IEC Standard allows the user to identify the changes made to
the previous edition IEC 61558-2-15:2011. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
IEC 61558-2-15 has been prepared by IEC technical committee 96: Transformers, reactors,
power supply units and combinations thereof. It is an International Standard.
This third edition cancels and replaces the second edition published in 2011. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) Adjustment of structure and references in accordance with IEC 61558-1:2017;
The text of this International Standard is based on the following documents:
Draft Report on voting
96/535/FDIS 96/536/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
It has the status of a group safety publication in accordance with IEC Guide 104.
This International Standard is to be used in conjunction with IEC 61558-1:2017.
NOTE When “Part 1” is mentioned in this standard, it refers to IEC 61558-1:2017.
This document supplements or modifies the corresponding clauses in IEC 61558-1:2017, so as
to convert that publication into the IEC standard: Particular requirements and tests for isolating
transformers for medical IT systems for the supply of medical locations.
A list of all parts in the IEC 61558 series published under the general title Safety of
transformers, reactors, power supply units and combinations thereof, can be found on the
IEC website.
Future standards in this series will carry the new general title as cited above. Titles of existing
standards in this series will be updated at the time of the next edition.
Where this document states "addition", "modification" or "replacement", the relevant text of
IEC 61558-1:2017 is to be adapted accordingly.
In this document, the following print types are used:
– re
...
IEC 61558-2-15 EXV ®
Edition 3.0 2022-09
EXTENDED VERSION
INTERNATIONAL
STANDARD
colour
This extended version of IEC 61558-2-15:2022 includes the content of
inside
the references made to IEC 61558-1:2017
GROUP SAFETY PUBLICATION
Safety of transformers, reactors, power supply units and combinations thereof –
Part 2-15: Particular requirements and tests for isolating transformers
for medical IT systems for the supply of medical locations
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 Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
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 corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
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Discover our powerful search engine and read freely all the
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and withdrawn publications.
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Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and once
and French, with equivalent terms in 19 additional languages.
a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or need
further assistance, please contact the Customer Service
Centre: sales@iec.ch.
IEC 61558-2-15 EXV ®
Edition 3.0 2022-09
EXTENDED VERSION
INTERNATIONAL
STANDARD
colour
This extended version of IEC 61558-2-15:2022 includes the content of inside
the references made to IEC 61558-1:2017
GROUP SAFETY PUBLICATION
Safety of transformers, reactors, power supply units and combinations thereof –
Part 2-15: Particular requirements and tests for isolating transformers
for medical IT systems for the supply of medical locations
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 29.180 ISBN 978-2-8322-5675-6
– 2 – IEC 61558-2-15:2022 EXV © IEC 2022
CONTENTS
FOREWORD .6
INTRODUCTION .9
1 Scope . 10
2 Normative references . 11
3 Terms and definitions . 14
4 General requirements . 28
5 General notes on tests . 29
6 Ratings . 31
7 Classification . 31
8 Marking and other information . 32
9 Protection against electric shock . 38
10 Change of input voltage setting . 42
11 Output voltage and output current under load . 43
12 No-load output voltage . 44
13 Short-circuit voltage and inrush currents . 44
14 Heating . 45
15 Short-circuit and overload protection. 53
16 Mechanical strength . 58
17 Protection against harmful ingress of dust, solid objects and moisture . 63
18 Insulation resistance, dielectric strength and leakage current . 67
19 Construction . 74
20 Components . 86
21 Internal wiring . 91
22 Supply connection and other external flexible cable or cords . 91
23 Terminals for external conductors . 97
24 Provisions for protective earthing . 99
25 Screws and connections . 100
26 Creepage distances, clearances and distances through insulation . 103
27 Resistance to heat, fire and tracking . 116
28 Resistance to rusting. 120
Annex A (normative) Measurement of creepage distances and clearances . 121
Annex B (normative) Testing a series of transformers . 125
Annex C (void) . 127
Annex D (void) . 128
Annex E (normative) Glow-wire test . 129
Annex F (normative) Requirements for manually operated switches which are parts of
transformers assembly . 130
Annex G (normative) Tracking test . 133
Annex H (normative) Electronic circuits . 134
Annex I (informative) Dimensions for rectangular cross-section connectors of
transformers, basic dimensions and coordination . 135
Annex J (normative) Measuring network for touch-currents . 138
Annex K (normative) Insulated winding wires . 139
Annex L (normative) Routine tests (production tests) . 142
Annex M (informative) Examples to be used as a guide for 19.1 . 144
Annex N (informative) Examples for checking points of dielectric strength test voltages. 147
Annex O (void) . 149
Annex P (informative) Examples for measurement points of creepage distances and
clearances . 150
Annex Q (informative) Explanation of IP numbers for degrees of protection . 153
Annex R (normative) Explanations of the application of 6.1.2.2.1 of IEC 60664-1:2007 . 156
Annex S (void) . 158
Annex T (void) . 159
Annex U (void) . 160
Annex V (informative) Symbols to be used for thermal cut-outs . 161
Annex W (normative) Coated printed circuit boards . 162
Bibliography . 163
Index of defined terms . 165
Figure 2 – Mounting box for flush-type transformer . 30
Figure 3 – Test pin (see IEC 61032, test probe 13). 40
Figure 4 – Standard test finger (see IEC 61032, test probe B) . 41
Figure 5 – Example of back-to-back method – Single phase . 49
Figure 6 – Example of back-to-back method – Three phase . 49
Figure 7 – Amplitude spectrum density for random testing . 62
Figure 8 – Normalised spectrum of shock . 63
Figure 9 – Test voltage sequence . 70
Figure 10 – Test configuration: single-phase equipment on star TN or TT system . 72
Figure 101 – Required circuit for measuring the leakage current from the output winding
to the earthing. 73
Figure 102 – Required circuit for measuring the leakage current at the protective earthing
conductor. 74
Figure 11 – Abrasion resistance test for insulating coated layers . 79
Figure 12 – Flexing test apparatus . 95
Figure 13 – Test arrangement for checking mechanical withstanding of insulating
materials in thin sheet layers . 108
Figure 14 – Ball-pressure apparatus . 116
Figure A.1 – Example 1 . 121
Figure A.2 – Example 2 . 122
Figure A.3 – Example 3 . 122
Figure A.4 – Example 4 . 122
Figure A.5 – Example 5 . 123
Figure A.6 – Example 6 . 123
– 4 – IEC 61558-2-15:2022 EXV © IEC 2022
Figure A.7 – Example 7 . 124
Figure A.8 – Example 8 . 124
Figure J.1 – Measuring network for touch-current . 138
Figure M.1 – Examples for concentric type constructions . 144
Figure M.2 – Examples for side-by-side type constructions . 145
Figure M.3 – Examples for winding constructions without screen . 145
Figure M.4 – Examples for wrapped winding constructions . 146
Figure M.5 – Examples for winding constructions with screen . 146
Figure N.1 – Transformer of class I construction with metal enclosure . 147
Figure N.2 – Transformer of class II construction with metal enclosure . 148
Figure N.3 – Transformer of class II construction with enclosu
...
IEC 61558-2-15 ®
Edition 3.0 2022-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety of transformers, reactors, power supply units and combinations thereof –
Part 2-15: Particular requirements and tests for isolating transformers
for medical IT systems for the supply of medical locations
Sécurité des transformateurs, bobines d’inductance, blocs d'alimentation et
des combinaisons de ces éléments –
Partie 2-15: Exigences particulières et essais pour les transformateurs de
séparation de circuits pour schémas IT médicaux pour l’alimentation des
locaux à usages médicaux
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
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copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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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 corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
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containing more than 22 300 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 19 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
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IEC 61558-2-15 ®
Edition 3.0 2022-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety of transformers, reactors, power supply units and combinations thereof –
Part 2-15: Particular requirements and tests for isolating transformers
for medical IT systems for the supply of medical locations
Sécurité des transformateurs, bobines d’inductance, blocs d'alimentation et
des combinaisons de ces éléments –
Partie 2-15: Exigences particulières et essais pour les transformateurs de
séparation de circuits pour schémas IT médicaux pour l’alimentation des
locaux à usages médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 29.180 ISBN 978-2-8322-1101-9
– 2 – IEC 61558-2-15:2022 © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 8
4 General requirements . 9
5 General notes on tests . 9
6 Ratings . 9
7 Classification . 10
8 Marking and other information . 10
9 Protection against electric shock . 11
10 Change of input voltage setting . 11
11 Output voltage and output current under load . 11
12 No-load output voltage . 11
13 Short-circuit voltage . 12
14 Heating . 13
15 Short-circuit and overload protection . 13
16 Mechanical strength . 13
17 Protection against harmful ingress of dust, solid objects and moisture . 13
18 Insulation resistance, dielectric strength and leakage current . 13
19 Construction . 16
20 Components . 18
21 Internal wiring . 18
22 Supply connection and other external flexible cable or cords . 18
23 Terminals for external conductors . 18
24 Provisions for protective earthing. 19
25 Screws and connections . 19
26 Creepage distances, clearances and distances through insulation . 19
27 Resistance to heat, fire and tracking . 19
28 Resistance to rusting . 19
Annexes . 20
Annex H (normative) Electronic circuits . 20
Annex L (normative) Routine tests (production tests) . 20
Bibliography . 21
Figure 101 – Required circuit for measuring the leakage current from the output
winding to the earthing . 15
Figure 102 – Required circuit for measuring the leakage current at the protective
earthing conductor . 16
Table 101 – Symbols indicating the kind of transformer . 11
Table 102 – Additional dielectric strength test voltages . 14
– 4 – IEC 61558-2-15:2022 © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY OF TRANSFORMERS, REACTORS,
POWER SUPPLY UNITS AND COMBINATIONS THEREOF –
Part 2-15: Particular requirements and tests for isolating transformers
for medical IT systems for the supply of medical locations
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
...
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