EN IEC 61558-2-15:2025

Sicherheit von Transformatoren, Drosseln, Netzgeräten und deren Kombinationen - Teil 2-15: Besondere Anforderungen und Prüfungen für Trenntransformatoren für medizinische IT-Systeme zur Versorgung medizinischer Räumlichkeiten

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 isolating transformers, single-phase or three-phase, air-cooled (natural or forced) dry-type 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. Transformers covered by this document are intended for medical IT systems for the supply of medical locations. All other transformers or equipments connected downstream from the transformer 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 does not be 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 may 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 3 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 and is not intended to be used in conjunction with IEC 61558-2-16 for switch mode 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. 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. NOTE National installation rules of some countries have different or additional requirements listed in Annex C of IEC 60364-7-710:2021. Attention is drawn 193 to the following: - for transformers intended to be used in vehicles, on board ships, and aircraft, additional requirements (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.

Sicherheit von Transformatoren, Drosseln, Netzgeräten und deren Kombinationen - Teil 2-15: Besondere Anforderungen und Prüfungen für Trenntransformatoren für medizinische IT-Systeme zur Versorgung medizinischer Räumlichkeiten

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.

Varnost transformatorjev, dušilk, napajalnikov in njihovih kombinacij - 2-15. del: Posebne zahteve in preskusi za ločilne transformatorje za IT sisteme v napajalnikih v medicinskih prostorih

Ta del standarda IEC 61558 obravnava varnost ločilnih transformatorjev za IT sisteme v napajalnikih v medicinskih prostorih. OPOMBA 1: Varnost vključuje električne, toplotne in mehanske vidike.  Če ni navedeno drugače, od tu dalje izraz »transformator« zajema ločilne transformatorje za IT sisteme v napajalnikih v medicinskih prostorih. Ta dokument se uporablja za enofazne ali trifazne, zračno hlajene (naravno ali umetno) suhe ločilne transformatorje za napajanje IT sistemov na medicinskih lokacijah iz skupine 2, ki so stalno povezani s fiksnim ožičenjem ter so del IT sistema na sekundarni strani. Navitja so lahko enkapsulirana ali neenkapsulirana. OPOMBA 2: IT sistemi so opredeljeni v standardu IEC 60364-1. Pravila namestitve IT sistemov na medicinskih lokacijah iz skupine 2 so zajeta v standardu IEC 60364-7-710. Transformatorji, obravnavani v tem dokumentu, se uporabljajo za IT sisteme v napajalnikih v medicinskih prostorih. Vsi drugi transformatorji oziroma oprema, priključena na nizkonapetostni strani transformatorja, v tem dokumentu ni zajeta. Nazivna napajalna napetost ne presega 1000 V izmenične napetosti. Nazivna napajalna frekvenca in notranja operativna frekvenca ne presegata 500 Hz. Za enofazne in trifazne transformatorje za IT sisteme na medicinskih lokacijah iz skupine 2 nazivna izhodna moč ni manjša od 0,5 kVA in ne presega 10 kVA. Ta dokument se lahko uporablja za ločilne transformatorje, namenjene napajanju drugih medicinskih naprav, ki niso medicinske lokacije iz skupine 2, brez omejitev nazivne izhodne moči, o čemer se dogovorita kupec in proizvajalec. OPOMBA 3: V to področje uporabe niso vključeni transformatorji, namenjeni napajanju razdelilnih omrežij, ki niso IT sistemi. Izhodna napetost brez obremenitve in nazivna izhodna napetost ne presegata 250 V izmenične napetosti za enofazne ali trifazne transformatorje (medfazna napetost). Ta dokument ne zajema napajalnikov in ga ni treba uporabljati v povezavi s standardom IEC 61558-2-16 za stikalne napajalnike. Ta dokument se ne uporablja za zunanja vezja in njihove sestavne dele, ki so namenjeni za povezavo z vhodnimi in izhodnimi priključki transformatorjev. Transformatorji, obravnavani v tem dokumentu, se uporabljajo, kadar je v skladu s pravili namestitve ali specifikacijo naprave potrebna dvojna ali okrepljena izolacija med vezji. OPOMBA: V skladu z nacionalnimi pravili namestitve nekaterih držav so v dodatku C standarda IEC 60364-7-710:2021 navedene drugačne ali dodatne zahteve. Upošteva se naslednje (193): – dodatne zahteve (iz drugih veljavnih standardov, nacionalnih pravil itd.) za transformatorje, ki so namenjeni za uporabo v vozilih, na ladjah in letalih; – ukrepi za zaščito ohišja in sestavnih delov v ohišju pred zunanjimi vplivi, kot so glive, mrčes, termiti, sončno sevanje in zmrzovanje; – različni pogoji za transport, shranjevanje in delovanje transformatorjev; – dodatne zahteve v skladu z drugimi ustreznimi standardi in nacionalnimi pravili, ki lahko veljajo za transformatorje, namenjene za uporabo v posebnih okoljih.  Ta PUBLIKACIJA SKUPINSKE VARNOSTI, ki se osredotoča na VARNOSTNE smernice, se uporablja predvsem kot STANDARD O VARNOSTI ZA IZDELKE, ki so omenjeni v okviru publikacije, vendar je namenjena tudi tehničnim odborom pri pripravi publikacij za izdelke, ki so podobni izdelkom, omenjenim v okviru te PUBLIKACIJE SKUPINSKE VARNOSTI, skladno z načeli vodil IEC 104 in ISO/IEC 51. Ena od DOLŽNOSTI tehničnega odbora je, da med pripravo publikacij uporablja osnovne varnostne publikacije (BSP) in/ali publikacije skupinske varnosti (GSP), kadar je to primerno.

General Information

• Status: Published
• Publication Date: 13-Mar-2025
• Withdrawal Date: 03-Jan-2023
• ICS: 29.180 - Transformers. Reactors
• Technical Committee: CLC/SR 96 - Small power transformers, reactors, power supply units and similar products
• Drafting Committee: IEC/TC 96 - IEC_TC_96
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 14-Mar-2025
• Completion Date: 14-Mar-2025
• Directive: 2014/35/EU - Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
• Mandate: M/511 - Mandate to CEN, CENELEC and ETSI relating to harmonised standards in the field of the Low Voltage Directive
• Ref Project: SIST EN IEC 61558-2-15:2025 - 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

Relations

• Replaces: EN 61558-2-15:2012 - Safety of transformers, reactors, power supply units and combinations thereof - Part 2-15: Particular requirements and tests for isolating transformers for the supply of medical locations
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2025
Nadomešča:
SIST EN 61558-2-15:2012
Varnost transformatorjev, dušilk, napajalnikov in njihovih kombinacij - 2-15. del:
Posebne zahteve in preskusi za ločilne transformatorje za IT sisteme v
napajalnikih v medicinskih prostorih
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
Sicherheit von Transformatoren, Drosseln, Netzgeräten und deren Kombinationen - Teil2
-15: Besondere Anforderungen und Prüfungen für Trenntransformatoren zur Versorgung
medizinischer Räume
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 locaux à
usages médicaux
Ta slovenski standard je istoveten z: EN IEC 61558-2-15:2025
ICS:
29.180 Transformatorji. Dušilke Transformers. Reactors
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 61558-2-15

NORME EUROPÉENNE
EUROPÄISCHE NORM March 2025
ICS 29.180 Supersedes EN 61558-2-15:2012
English Version
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)
Sécurité des transformateurs, bobines d'inductance, blocs Sicherheit von Transformatoren, Drosseln, Netzgeräten und
d'alimentation et des combinaisons de ces éléments - deren Kombinationen - Teil2-15: Besondere Anforderungen
Partie 2-15: Exigences particulières et essais pour les und Prüfungen für Trenntransformatoren zur Versorgung
transformateurs de séparation de circuits pour schémas IT medizinischer Räume
médicaux pour l'alimentation des locaux à usages (IEC 61558-2-15:2022)
médicaux
(IEC 61558-2-15:2022)
This European Standard was approved by CENELEC on 2024-10-16. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61558-2-15:2025 E

European foreword
The text of document 96/535/FDIS, future edition 3 of IEC 61558-2-15, prepared by TC 96
"Transformers, reactors, power supply units, and combinations thereof" was submitted to the IEC-
CENELEC parallel vote and approved by CENELEC as EN IEC 61558-2-15:2025.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-03-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-03-31
document have to be withdrawn
This document supersedes EN 61558-2-15:2012 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document is read in conjunction with EN IEC 61558-1:2019.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61558-2-15:2022 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 standard indicated:
IEC 61558 series NOTE Approved as EN 61558 series
IEC 60364-1:2005 NOTE Approved as HD 60364-1:2008 +A11:2017
IEC 60364-4-41:2005 NOTE Approved as HD 60364-4-41:2017 +A11:2017
IEC 60364-7-710:2021 NOTE Approved as HD 60364-7-710:— (not modified) +A11:—
IEC 61557-8:2014 NOTE Approved as EN 61557-8:2015 (not modified)

Under preparation. Stage at the time of publication: FprHD 60364-7-710:2021 and FprHD 60364-7-
710:2021/FprA11:2021.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
NOTE 1  Where 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.cencenelec.eu.
Annex ZA of EN IEC 61558-1 is applicable, except as follows:
Add:
Publication Year Title EN/HD Year
IEC 61558-1 2017 Safety of transformers, reactors, power EN IEC 61558-1 2019
supply units and combinations thereof -
Part 1: General requirements and tests

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 978-2-8322-5040-2
– 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

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

– 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 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.
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;

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.
– 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.

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 d
...