EN IEC 61558-2-15:2025
(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
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 - 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 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
General Information
Relations
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 te
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