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 is available as IEC 61558-2-15:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.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

IEC 61558-2-15:2022 est disponible sous forme de IEC 61558-2-15:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.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.

General Information

Status
Published
Publication Date
01-May-2022
Current Stage
PPUB - Publication issued
Completion Date
02-May-2022
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IEC 61558-2-15:2022 - 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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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
IEC 61558-2-15:2022-05(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 61558-2-15:2022  IEC 2022 – 3 –

Table 101 – Symbols indicating the kind of transformer ........................................................ 11

Table 102 – Additional dielectric strength test voltages ......................................................... 14

---------------------- Page: 5 ----------------------
– 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.

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any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.

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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

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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.

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;
---------------------- Page: 6 ----------------------
IEC 61558-2-15:2022  IEC 2022 – 5 –
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:
– requirements proper: in roman type;
– test specifications: in italic type;
– explanatory matter: in smaller roman type.
In the text of this document, the words in bold are defined in Clause 3.

Subclauses, notes, figures and tables additional to those in IEC 61558-1:2017 are numbered

starting from 101; supplementary annexes are entitled AA, BB, etc.

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under webstore.iec.ch in the data related to the

specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 7 ----------------------
– 6 – IEC 61558-2-15:2022 © IEC 2022
INTRODUCTION

IEC TC 96 has a group safety function in accordance with IEC Guide 104 for transformers other

than those intended to supply distribution networks, in particular transformers and power supply

units intended to allow the application of protective measures against electric shock as defined

by TC 64, but in certain cases including the limitation of voltage and horizontal safety function

for SELV, in accordance with IEC 60364-4-41.

The group safety function (GSF) is necessary because of responsibility for safety extra-low

voltage (SELV) in accordance with IEC 61140:2016, 5.2.6 and IEC 60364-4-41:2005, 414.3.1

or control circuits in accordance with IEC 60204-1:2016, 7.2.4.

The group safety function is needed for each part of IEC 61558-2 because different standards

of the IEC 61558 series can be combined in one construction but in certain cases with no

limitation of rated output power.

For example an auto-transformer in accordance with IEC 61558-2-13 can be designed with a

separate SELV-circuit in accordance with the particular requirements for IEC 61558-2-6 relating

to the general requirements of IEC 61558-1.
---------------------- Page: 8 ----------------------
IEC 61558-2-15:2022  IEC 2022 – 7 –
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
1 Scope
Replacement

This part of IEC 61558 deals with safety of isolating transformers for medical IT systems

for the supply of medical locations.
NOTE 1 Safety includes electrical, thermal and mechanical aspects.

Unless otherwise specified, from here onward, the term transformer covers isolating

transformers for medical IT systems for the supply of medical locations.

This document is applicable to stationary, single-phase or three-phase, air-cooled (natural or

forced) dry-type isolating transformers for the supply of medical IT system for group 2

medical locations, designed to be permanently connected to the fixed wiring and intended to

form the medical IT system on the secondary side. The windings can be encapsulated or non-

encapsulated.
NOTE 2 IT systems are defined in IEC 60364-1.

The installation rules for medical IT system for group 2 medical locations are covered by

IEC 60364-7-710.

NOTE 3 National installation rules of some countries have different or additional requirements listed in Annex C of

IEC 60364-7-710:2021.

Transformers covered by this document are intended for medical IT systems for the supply

of medical locations. All other transformers or equipment are not covered by this document.

The rated supply voltage does not exceed 1 000 V AC. The rated supply frequency and

internal operational frequency do not exceed 500 Hz.

The rated output is not less than 0,5 kVA and does not exceed 10 kVA for single-phase and

three-phase transformers for medical IT system for group 2 medical locations.

This document can be applicable to isolating transformers intended to supply other medical

installations that are not group 2 medical locations without limitation of the rated output subject

to an agreement between the purchaser and the manufacturer.

NOTE 4 Transformers intended to supply distribution networks other than medical IT systems are not included in

the scope.

The no-load output voltage and the rated output voltage does not exceed 250 V AC for

single-phase or three-phase transformer (phase-to-phase voltage).
This document does not cover power supply units.

This document is not applicable to external circuits and their components intended to be

connected to the input terminals and output terminals of the transformers.
---------------------- Page: 9 ----------------------
– 8 – IEC 61558-2-15:2022 © IEC 2022

Transformers covered by this document are used in applications where double or reinforced

insulation between circuits is required by the installation rules or by the appliance specification.

Attention is drawn to the following, if necessary:

– additional requirements for transformers intended to be used in vehicles, on board ships,

and aircraft (from other applicable standards, national rules, etc.);

– measures to protect the enclosure and the components inside the enclosure against

external influences such as fungus, vermin, termites, solar-radiation, and icing;

– the different conditions for transportation, storage, and operation of the transformers;

– additional requirements in accordance with other appropriate standards and national rules

may be applicable to transformers intended for use in special environments.

This group safety publication focusing on safety guidance is primarily intended to be used as a

product safety standard for the products mentioned in the scope, but is also intended to be used

by TCs in the preparation of publications for products similar to those mentioned in the scope

of this group safety publication, in accordance with the principles laid down in IEC Guide 104

and lSO/lEC Guide 51.

One of the responsibilities of a TC is, wherever applicable, to make use of BSPs and/or GSPs

in the preparation of its publications.
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition

IEC 61558-1:2017, Safety of transformers, reactors, power supply units and combinations

thereof – Part 1: General requirements and tests
3 Terms and definitions

For the purposes of this document, the terms and definitions given in Part 1 apply, except as

follows:

ISO and IEC maintain terminology databases for use in standardization at the following

addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
Addition
3.1.101
isolating transformer for medical IT systems for the supply of medical locations

isolating transformer used for the supply of medical IT system for group 2 medical locations,

designed to be permanently connected and with double or reinforced insulation between each

part of the transformer (body, screen, circuits, thermal sensitive device) except between the

core and the body
3.2.101
medical IT system

electric IT system fulfilling all specific additional requirements of group 2 medical locations

[SOURCE: IEC 60364-7-710:2021, 710.3.10, modified – Note 1 to entry has been deleted.]

---------------------- Page: 10 ----------------------
IEC 61558-2-15:2022  IEC 2022 – 9 –
3.5.101
rated input current

input current assigned to the transformer by the manufacturer, when the transformer is loaded

with rated output
3.6.101
no-load input current

input current when the transformer is connected to the rated supply voltage, at the rated

supply frequency, with no-load on the output
3.6.102
inrush current

maximum instantaneous value of the no-load input current of the transformer (peak value)

when the transformer is switched on at rated supply voltage
3.7.101
functional screening

separation between two windings or between a winding and the core or shielding of a part or of

the whole transformer, by means of an interposed conductive screen for functional reasons

4 General requirements
This clause of Part 1 is applicable.
5 General notes on tests
This clause of Part 1 is applicable.
6 Ratings
This clause of Part 1 is applicable except as follows:
Addition

6.101 The rated output voltage shall not exceed 250 V AC for single-phase or three-phase

transformers (phase-to-phase voltage).

6.102 The rated output shall not be less than 0,5 kVA and shall not exceed 10 kVA for single-

phase or three-phase transformers.

Transformers intended to supply other medical installations that are not group 2 medical

locations without limitation of the rated output shall be subject to an agreement between the

purchaser and the manufacturer.

6.103 The rated frequency and internal operational frequency shall not exceed 500 Hz.

6.104 The rated supply voltage shall not exceed 1 000 V AC.

Compliance with the requirements of 6.101 to 6.104 shall be checked by inspection of the

marking.
---------------------- Page: 11 ----------------------
– 10 – IEC 61558-2-15:2022 © IEC 2022
7 Classification
This clause of Part 1 is applicable, except as follows:
Replacement
7.2

Transformers shall be non-short-circuit proof transformers in accordance with the short-

circuit characteristic or protection against abnormal use.
7.4
Transformers shall be stationary transformers.
7.5
Transformers shall be classified for continuous duty.
7.8
Transformers shall be classified for overvoltage category III.
8 Marking and other information
This clause of Part 1 is applicable except as follows:
8.1 h)
Replacement
Replace the content up to the first semi-colon by the following:

relevant graphical symbols shown in Table 101 that indicate the kind of transformer

8.1 s)
Replacement

Transformers shall be marked with the measured short-circuit voltage expressed as a

percentage of the rated supply voltage.
Addition

8.1.101 When the inrush current exceeds 8 times the peak value of the rated input current,

the resulting value shall be marked on the transformer.
8.6
Addition
All terminals shall be clearly marked.
---------------------- Page: 12 ----------------------
IEC 61558-2-15:2022  IEC 2022 – 11 –
8.11
Addition
Table 101 – Symbols indicating the kind of transformer
Symbol or graphical symbol Explanation or title Identification
Non-short-circuit proof isolating transformers IEC 60417-5972:2003-08
for medical IT systems for the supply of
group 2 medical locations
NOTE This symbol is not applicable for
transformers > 10 kVA
8.14
Addition

The instruction sheet shall state: "Screens whose connection to the earthing is necessary for

compliance with the leakage current requirements of Clause 18 shall be connected to the

earthing."

The instruction sheet shall include type and characteristic of sensor to over-temperature

monitoring, if any.

The rated input current shall be provided as information given either on the transformer

marking or made available in the manufacturer's catalogue or similar.
9 Protection against electric shock
This clause of Part 1 is applicable.
10 Change of input voltage setting
This clause of Part 1 is applicable.
11 Output voltage and output current under load
This clause of Part 1 is applicable.
12 No-load output voltage
This clause of Part 1 is applicable except as follows:
Addition

12.101 The no-load output voltage (phase-to-phase voltage) shall not exceed 250 V AC for

single-phase or three-phase transformers.

12.102 The difference between the no-load output voltage and the output voltage under

load shall not be excessive.
---------------------- Page: 13 ----------------------
– 12 – IEC 61558-2-15:2022 © IEC 2022

The ratio between the no-load output voltage measured in Clause 12 and the output voltage

under load measured during the test of Clause 11, expressed as a percentage of the latter

voltage, shall not exceed 5 %.
The ratio is determined by Formula (1):
UU−
no-load load
×100 %
( ) (1)
load
where
U is the no-load output voltage, expressed in V;
no-load
U is the no-load output voltage, expressed in V.
load
Compliance wit
...

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