oSIST prEN IEC 61558-2-15:2021

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 locaux à usages médicaux

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

• Status: Not Published
• Public Enquiry End Date: 17-Jul-2021
• ICS: 29.180 - Transformers. Reactors
• Technical Committee: I96 - Imaginarni 96
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 04-Mar-2022
• Due Date: 22-Apr-2022
• 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: FprEN 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

RELATIONS

• Revised: SIST EN 61558-2-15:2012 - Safety of transformers, reactors, power supply units and combination thereof - Part 2-15: Particular requirements and tests for isolating transformers for the supply of medical locations
• Effective Date: 30-Mar-2021

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN IEC 61558-2-15:2021
01-julij-2021

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
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: prEN IEC 61558-2-15:2021
ICS:
29.180 Transformatorji. Dušilke Transformers. Reactors
oSIST prEN IEC 61558-2-15:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 61558-2-15:2021
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oSIST prEN IEC 61558-2-15:2021
96/508/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61558-2-15 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-04-30 2021-07-23
SUPERSEDES DOCUMENTS:
96/503/RR
IEC TC 96 : TRANSFORMERS, REACTORS, POWER SUPPLY UNITS, AND COMBINATIONS THEREOF
SECRETARIAT: SECRETARY:
Germany Mr Wolfgang Reichelt
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
SC 3C,TC 14,TC 22,SC 22E,SC 34C,TC 51,TC
55,TC 61,TC 62,SC 62A,TC 64,TC 66,TC 77,TC
Other TC/SCs are requested to indicate their interest, if
97,TC 106,TC 108,TC 109,TC 111,TC 112
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of

which they are aware and to provide supporting documentation.
TITLE:

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
PROPOSED STABILITY DATE: 2025
NOTE FROM TC/SC OFFICERS:

Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to

download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National

Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it,

for any other purpose without permission in writing from IEC.
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oSIST prEN IEC 61558-2-15:2021
61558-2-15/Ed.3/CDV © IEC(E) 2 96/508/CDV
1 CONTENTS

3 FOREWORD......................................................................................................................... 3

4 INTRODUCTION ................................................................................................................... 5

5 1 Scope ............................................................................................................................ 6

6 2 Normative references .................................................................................................... 7

7 3 Terms and definitions .................................................................................................... 7

8 4 General requirements .................................................................................................... 8

9 5 General notes on tests ................................................................................................... 8

10 6 Ratings .......................................................................................................................... 8

11 7 Classification ................................................................................................................. 8

12 8 Marking and other information ........................................................................................ 9

13 9 Protection against electric shock .................................................................................. 10

14 10 Change of input voltage setting .................................................................................... 10

15 11 Output voltage and output current under load ............................................................... 10

16 12 No-load output voltage ................................................................................................. 10

17 13 Short-circuit voltage ..................................................................................................... 11

18 13 Short-circuit voltage and inrush currents ...................................................................... 11

19 14 Heating ....................................................................................................................... 12

20 15 Short-circuit and overload protection ............................................................................ 12

21 16 Mechanical strength ..................................................................................................... 12

22 17 Protection against harmful ingress of dust, solid objects and moisture .......................... 12

23 18 Insulation resistance, dielectric strength and leakage current ........................................ 12

24 19 Construction ................................................................................................................ 15

25 20 Components ................................................................................................................ 17

26 21 Internal wiring .............................................................................................................. 17

27 22 Supply connection and other external flexible cable or cords ........................................ 17

28 23 Terminals for external conductors ................................................................................ 17

29 24 Provisions for protective earthing ................................................................................. 17

30 25 Screws and connections .............................................................................................. 17

31 26 Creepage distances, clearances and distances through insulation ................................ 17

32 27 Resistance to heat, fire and tracking ............................................................................ 18

33 28 Resistance to rusting ................................................................................................... 18

34 Annexes ............................................................................................................................. 19

35 Annex H - Electronic circuits ............................................................................................... 19

36 Annex L - Routine tests (production tests) ........................................................................... 19

37 Bibliography ....................................................................................................................... 20

39 Table 101 – Symbols indicating the kind of transformer ....................................................... 10

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42 INTERNATIONAL ELECTROTECHNICAL COMMISSION
43 ____________
45 SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND
46 COMBINATIONS THEREOF –
48 Part 2-15: Particular requirements and tests for isolating transformers for
49 medical IT systems for the supply of medical locations
53 FOREWORD

54 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

55 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international

56 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and

57 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,

58 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their

59 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with

60 may participate in this preparatory work. International, governmental and non-governmental organizations liaising

61 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for

62 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.

63 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

64 consensus of opinion on the relevant subjects since each technical committee has representation from all

65 interested IEC National Committees.

66 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

67 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

68 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

69 misinterpretation by any end user.

70 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

71 transparently to the maximum extent possible in their national and regional publications. Any divergence between

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

73 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

74 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

75 services carried out by independent certification bodies.

76 6) All users should ensure that they have the latest edition of this publication.

77 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

78 members of its technical committees and IEC National Committees for any personal injury, property damage or

79 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

80 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

81 Publications.

82 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

83 indispensable for the correct application of this publication.

84 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent

85 rights. IEC shall not be held responsible for identifying any or all such patent rights.

86 International standard IEC 61558-2-15 has been prepared by IEC technical committee 96:

87 Transformers, reactors, power supply units and combinations thereof.

88 This third edition cancels and replaces the second edition published in 2011. It constitutes a

89 technical revision.

90 This edition includes the following significant technical changes with respect to the previous

91 edition:

92 a) Adjustment of structure and references in accordance with IEC 61558-1:2017;

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oSIST prEN IEC 61558-2-15:2021
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95 The text of this International Standard is based on the following documents:
Draft Report on voting
96/XXX/FDIS 96/XXX/RVD

97 Full information on the voting for its approval can be found in the report on voting indicated in

98 the above table.

99 The language used for the development of this International Standard is English.

100 This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in

101 accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available

102 at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are

103 described in greater detail at www.iec.ch/standardsdev/publications.

104 It has the status of a group safety publication in accordance with IEC Guide 104.

105 This International Standard is to be used in conjunction with IEC 61558-1:2017.

106 NOTE When “Part 1” is mentioned in this standard, it refers to IEC 61558-1:2017.

107 This document supplements or modifies the corresponding clauses in IEC 61558-1:2017, so as

108 to convert that publication into the IEC standard: Particular requirements and tests for isolating

109 transformers for the supply of medical locations – Transformer for medical IT systems.

110 A list of all parts in the IEC 61558 series published under the general title Safety of

111 transformers, reactors, power supply units and combinations thereof, can be found on the

112 IEC website.

113 Future standards in this series will carry the new general title as cited above. Titles of existing

114 standards in this series will be updated at the time of the next edition.

115 Where this document states "addition", "modification" or "replacement", the relevant text of

116 IEC 61558-1:2017 is to be adapted accordingly.
117 In this document, the following print types are used:
118 − requirements proper: in roman type;
119 − test specifications: in italic type;
120 − explanatory matter: in smaller roman type:
121 In the text of this document, the words in bold are defined in Clause 3.

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

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

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

125 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

126 the specific document. At this date, the document will be
127 • reconfirmed,
128 • withdrawn,
129 • replaced by a revised edition, or
130 • amended.
131
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132 INTRODUCTION

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

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

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

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

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

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

139 voltage (SELV) in accordance with IEC 61140:2016, 5.2.6 and IEC 60364-4-41:2017, 414.3.1

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

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

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

143 limitation of rated output power.

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

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

146 to the general requirements of IEC 61558-1.
147
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148 SAFETY OF TRANSFORMERS, REACTORS,
149 POWER SUPPLY UNITS AND COMBINATIONS THEREOF –
150
151 Part 2-15: Particular requirements and tests for isolating transformers for
152 medical IT systems for the supply of medical locations
153
154
155 1 Scope
156 Replacement

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

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

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

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

162 This document is applicable to isolating transformers, single-phase or three-phase, air-cooled

163 (natural or forced) dry-type transformers for the supply of medical IT system for group 2

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

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

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

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

169 IEC 60364-7-710.

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

171 of medical locations. All other transformers or equipments connected downstream from the

172 transformer are not covered by this document.

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

174 internal operational frequency do not exceed 500 Hz.

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

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

177 This document may be applicable to isolating transformers intended to supply other medical

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

179 to an agreement between the purchaser and the manufacturer.

180 NOTE 3 Transformers intended to supply distribution networks other than medical IT systems are not included in

181 the scope.

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

183 single-phase or three-phase transformer (phase-to-phase voltage).

184 This document does not cover power supply units and is not intended to be used in conjunction

185 with IEC 61558-2-16 for switch mode power supply units.

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

187 connected to the input terminals and output terminals of the transformers.

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

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

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

191 IEC 60364-7-710:2021.
192
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193 Attention is drawn to the following:

194 − for transformers intended to be used in vehicles, on board ships, and aircraft, additional

195 requirements (from other applicable standards, national rules, etc.);

196 − measures to protect the enclosure and the components inside the enclosure against

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

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

199 − additional requirements in accordance with other appropriate standards and national

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

201 This GROUP SAFETY PUBLICATION focusing on SAFETY guidance is primarily intended to

202 be used as a PRODUCT SAFETY STANDARD for the products mentioned in the scope, but is

203 also intended to be used by TCs in the preparation of publications for products similar to those

204 mentioned in the scope of this GROUP SAFETY PUBLICATION, in accordance with the

205 principles laid down in IEC Guide 104 and lSO/lEC Guide 51.

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

207 GSPs in the preparation of its publications.
208
209 2 Normative references
210 This clause of Part 1 is applicable except as follows:
211 Addition

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

213 thereof – Part 1: General requirements and tests
214
215 3 Terms and definitions

216 For the purposes of this document, the terms and definitions given in Part 1 apply.

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

218 addresses:
219 • IEC Electropedia: available at http://www.electropedia.org/
220 • ISO Online browsing platform: available at http://www.iso.org/obp
221
222 Addition
223 3.1.2.101

224 isolating transformers for medical IT systems for the supply of medical locations

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

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

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

228 core and the body
229 3.2.101
230 medical IT system
231 electric IT system fulfilling all specific
...