SIST HD 60364-7-710:2025
(Main)Low voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations (IEC 60364-7-710:2021)
Low voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations (IEC 60364-7-710:2021)
The particular requirements of this part of IEC 60364 apply to electrical installations in
medical locations so as to provide safety of patients and medical staff. These requirements
refer to:
- hospitals and clinics or equivalent institutions (including equivalent transportable and
mobile locations);
which, subject to assessment (710.30), can also include:
- sanatoriums and health clinics;
- dedicated locations in homes for senior citizens and aged care homes, where patients
receive medical care;
- medical centres, outpatients' clinics and departments, casualty wards;
- other outpatients' institutions (industrial, sports and others);
- medical and dental practices;
- dedicated medical rooms in the workplace;
- other locations where medical electrical equipment is used;
- veterinary clinics;
- rooms in existing installations where a change of utilization for medical applications occur.
This list is not exhaustive.
The requirements of this document do not apply to ME equipment or ME systems.
NOTE 1 Medical ME equipment and ME systems are covered by IEC 60601 (all parts).
NOTE 2 In the USA, the requirements of NFPA 70®, National Electrical Code® in general and specifically article
517 (Healthcare Facilities) apply.
Errichten von Niederspannungsanlagen - Teil 7-710: Anforderungen für Betriebsstätten, Räume und Anlagen besonderer Art - Medizinisch genutzte Bereiche (IEC 60364-7-710:2021)
Installations électriques à basse tension - Partie 7-710: Règles pour les installations ou emplacements spéciaux - Locaux à usages médicaux (IEC 60364-7-710:2021)
IEC 60364-7-710:2021 est applicables à des installations électriques de locaux à usages médicaux afin d'assurer la sécurité des patients et du personnel médical. Ces exigences se réfèrent généralement à:
– des hôpitaux et des cliniques ou des établissements équivalents (y compris des locaux analogues transportables et mobiles);
qui, sous réserve d’évaluation (710.30), peuvent également inclure:
– des sanatoriums et des cliniques médicales;
– des emplacements dédiés dans les foyers pour personnes âgées, où les patients reçoivent des soins médicaux;
– des centres médicaux, des centres de traitements ambulatoires et des services de consultations externes, des salles d’urgence;
– d’autres établissements (industriels, sportifs et autres) de consultations externes;
– des cabinets médicaux et dentaires;
– des locaux médicaux sur des sites de travail;
– d'autres locaux où des appareils électromédicaux sont utilisés;
– des cliniques vétérinaires;
– des salles dans des locaux existants en cas de changement d’utilisation de local pour des applications médicales.
Cette liste n’est pas exhaustive.
Les exigences du présent document ne s'appliquent pas aux appareils EM ou aux systèmes EM.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) le domaine d’application fournit de meilleures informations sur l’application du présent document;
b) certains termes et définitions ont été révisés;
c) la validité des parties correspondantes de la série IEC 60364 a été vérifiée et des articles ont été mis à jour;
d) l’Article 710.30 a été étendu;
e) l’Article 710.41 a été mis à jour;
f) l’Article 710.413 devient désormais l’Article 710.411;
g) les systèmes de localisation de défaut d’isolement ont été ajoutés à l’Article 710.411;
h) l’Article 710.421 a été étendu pour inclure les dispositifs pour la détection d’arcs;
i) l’Article 710.44 a été ajouté;
j) l’Article 710.51 a été mis à jour et couvre désormais les tableaux de distribution et les zones d’opérations électriques;
k) l’Article 710.514 a été étendu et comprend des paragraphes distincts sur les schémas, la documentation et les instructions de fonctionnement;
l) les paragraphes 710.531 à 710.537 ont été ajoutés;
m) l’Article 710.55 a été mis à jour;
n) l’Article 710.56 a été ajouté;
o) l’Article 710.6, Vérification, a été révisé;
p) l’Annexe A est supprimée et son contenu a été inséré dans le 710.560.4;
q) l’ancienne Annexe B devient désormais l’Annexe A et a été mise à jour;
r) une Annexe B informative de recommandations relatives aux perturbations électromagnétiques (EMI) sur les installations des bâtiments, a été ajoutée.
Nizkonapetostne električne inštalacije - 7-710. del: Zahteve za posebne inštalacije ali lokacije - Medicinski prostori (IEC 60364-7-710:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Nadomešča:
SIST HD 60364-7-710:2012
SIST HD 60364-7-710:2012/AC:2013
Nizkonapetostne električne inštalacije - 7-710. del: Zahteve za posebne inštalacije
ali lokacije - Medicinski prostori (IEC 60364-7-710:2021)
Low voltage electrical installations - Part 7-710: Requirements for special installations or
locations - Medical locations (IEC 60364-7-710:2021)
Errichten von Niederspannungsanlagen - Teil 7-710: Anforderungen für Betriebsstätten,
Räume und Anlagen besonderer Art - Medizinisch genutzte Bereiche (IEC 60364-7-
710:2021)
Installations électriques à basse tension - Partie 7-710: Règles pour les installations ou
emplacements spéciaux - Locaux à usages médicaux (IEC 60364-7-710:2021)
Ta slovenski standard je istoveten z: HD 60364-7-710:2025
ICS:
11.020.99 Drugi standardi v zvezi z Other standards related to
zdravstvom na splošno health care in general
91.140.50 Sistemi za oskrbo z elektriko Electricity supply systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
HARMONIZATION DOCUMENT HD 60364-7-710
DOCUMENT D'HARMONISATION
HARMONISIERUNGSDOKUMENT October 2025
ICS 29.020; 91.140.50 Supersedes HD 60364-7-710:2012; HD 60364-7-
710:2012/AC:2013
English Version
Low-voltage electrical installations - Part 7-710: Requirements
for special installations or locations - Medical locations
(IEC 60364-7-710:2021)
Installations électriques à basse tension - Partie 7-710: Errichten von Niederspannungsanlagen - Teil 7-710:
Exigences pour les installations ou emplacements spéciaux Anforderungen für Betriebsstätten, Räume und Anlagen
- Locaux à usages médicaux besonderer Art - Medizinisch genutzte Bereiche
(IEC 60364-7-710:2021) (IEC 60364-7-710:2021)
This Harmonization Document was approved by CENELEC on 2021-06-09. CENELEC members are bound to comply with the
CEN/CENELEC Internal Regulations which stipulate the conditions for implementation of this Harmonization Document at national level.
Up-to-date lists and bibliographical references concerning such national implementations may be obtained on application to the CEN-
CENELEC Management Centre or to any CENELEC member.
This Harmonization Document exists in three official versions (English, French, German).
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. HD 60364-7-710:2025 E
European foreword
The text of document 64/2480/FDIS, future edition 2 of IEC 60364-7-710, prepared by IEC/TC 64
"Electrical installations and protection against electric shock" was submitted to the IEC-CENELEC
parallel vote and approved by CENELEC as HD 60364-7-710:2025.
The following dates are fixed:
• latest date by which the document has to be implemented (dop) 2026-10-31
at national level by publication of an identical national
standard or by endorsement
• latest date by which the national standards conflicting with (dow) 2028-10-31
the document have to be withdrawn
This document supersedes HD 60364-7-710:2012 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.
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 60364-7-710:2021 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 standards
indicated:
IEC 60364-5-55:2011 NOTE Approved as HD 60364-5-559:2012 + A11:2017
IEC 60364-5-55:2011/A1:2012 NOTE Approved as HD 60364-5-557:2013 (not modified)
+ A11:2016
IEC 60445:2017 NOTE Approved as EN 60445:2017 (not modified)
IEC 60601 (series) NOTE Approved as EN 60601 (series)
IEC 60601-1:2005 NOTE Approved as EN 60601-1:2006 (not modified) + A11:2011
IEC 60601-1:2005/A1:2012 NOTE Approved as EN 60601-1:2006/A1:2013 (not modified)
IEC 60601-1:2005/A2:2020 NOTE Approved as EN 60601-1:2006/A2:2021 (not modified)
IEC 61000 (series) NOTE Approved as EN IEC 61000 (series)
IEC 61340 (series) NOTE Approved as EN IEC 61340 (series)
IEC 61340-6-1:2018 NOTE Approved as EN IEC 61340-6-1:2018 (not modified)
IEC 62020-1 NOTE Approved as EN IEC 62020-1
IEC 62040-1:2017 NOTE Approved as EN IEC 62040-1:2019 (not modified)
+ A11:2021
ISO 11197 NOTE Approved as EN ISO 11197
IEC 60364-7-710 ®
Edition 2.0 2021-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Low-voltage electrical installations –
Part 7-710: Requirements for special installations or locations – Medical
locations
Installations électriques à basse tension –
Partie 7-710: Exigences pour les installations ou emplacements spéciaux –
Locaux à usages médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 29.020; 91.140.50 ISBN 978-2-8322-9592-2
– 2 – IEC 60364-7-710:2021 © IEC 2021
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
710 Medical locations . 7
710.1 Scope . 7
710.2 Normative references . 7
710.3 Terms and definitions . 8
710.30 Assessment of general characteristics . 11
710.31 Purposes, supplies and structure . 11
710.313 Supplies . 11
710.314 Division of installation . 12
710.41 Protection for safety – Protection against electric shock . 12
710.411 Protective measure: automatic disconnection of supply . 12
710.414 Protective measure: extra-low-voltage provided by SELV and PELV . 14
710.415 Additional protection . 14
710.42 Protection for safety – Protection against thermal effects . 15
710.421 Protection against fire caused by electrical equipment . 15
710.44 Protection for safety – Protection against voltage disturbances and
electromagnetic disturbances . 15
710.444 Measures against electromagnetic influences . 15
710.51 Selection and erection of electrical equipment – Common rules . 16
710.512 Operational conditions and external influences . 17
710.514 Identification . 17
710.52 Selection and erection of electrical equipment – Wiring systems . 18
710.53 Selection and erection of electrical equipment – Devices for protection
for safety, isolation, switching, control and monitoring . 19
710.531 Equipment for protection against electric shock . 19
710.535 Co-ordination of protective devices . 20
710.536 Isolation and switching . 20
710.537 Monitoring . 20
710.55 Selection and erection of electrical equipment – Other equipment . 21
710.559 Luminaires and lighting installations . 21
710.56 Selection and erection of electrical equipment – Safety services . 21
710.6 Verification . 24
Annex A (informative) Examples of allocation of group numbers and classification for
an electric supply system for safety services of medical locations . 27
Annex B (informative) Guidance concerning electromagnetic interferences (EMI) . 28
Annex C (informative) List of notes concerning certain countries (exceptions) . 29
Bibliography . 39
Figure 710.1 – Example of a patient environment . 26
Table A.710.1 – List of examples of medical locations and their group classification
(guideline) . 27
Table B.710.1 – Minimum distances . 28
IEC 60364-7-710:2021 © IEC 2021 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
LOW-VOLTAGE ELECTRICAL INSTALLATIONS –
Part 7-710: Requirements for special installations or locations –
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 60364-7-710 has been prepared by IEC technical committee 64: Electrical installations
and protection against electric shock. It is an International Standard.
This second edition cancels and replaces the first edition published in 2002. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) the scope provides improved information to the application of this document;
b) some terms and definitions have been revised;
c) the validity of the respective parts of the IEC 60364 series has been verified and clauses
updated;
d) Clause 710.30 has been extended;
– 4 – IEC 60364-7-710:2021 © IEC 2021
e) Clause 710.41 has been updated;
f) Clause 710.413 has been renumbered as Clause 710.411;
g) in 710.411 insulation fault location systems have been added;
h) Clause 710.421 has been extended to include arc fault detection devices;
i) Clause 710.44 has been added;
j) Clause 710.51 has been updated and now covers distribution boards and electrical
operating areas;
k) Clause 710.514, has been extended and includes separate subclauses on diagrams,
documentation and operating instructions;
l) Subclauses 710.531 to 710.537 have been added;
m) Clause 710.55 has been updated;
n) Clause 710.56 has been added;
o) Clause 710.6, Verification, has been revised;
p) Annex A was deleted, and the contents integrated into 710.560.4;
q) former Annex B is now Annex A and has been updated;
r) an informative Annex B on guidance concerning electromagnetic interferences (EMI) in
installations of buildings has been added.
The text of this International Standard is based on the following documents:
Draft Report on voting
64/2480/FDIS 64/2482/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.
A list of all parts in the IEC 60364 series, published under the general title Low-voltage
electrical installations, can be found on the IEC website.
The reader's attention is drawn to the fact that Annex C lists all of the "in-some-country"
clauses on differing practices of a less permanent nature relating to the subject of this
document.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://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.
IEC 60364-7-710:2021 © IEC 2021 – 5 –
INTRODUCTION
For the purpose of this part of IEC 60364 (IEC 60364-7-710) the requirements of the general
Parts 1 to 6 and Part 8 of IEC 60364 apply.
The IEC 60364-7-7XX parts of IEC 60364 contain particular requirements for special
installations or locations which are based on the requirements of the general parts of
IEC 60364 (IEC 60364-1 to IEC 60364-6 and IEC 60364-8). These IEC 60364-7-7XX parts are
considered in conjunction with the requirements of the general parts.
The particular requirements of this part of IEC 60364 supplement, modify or replace certain of
the requirements of the general parts of IEC 60364 being valid at the time of publication of
this part. The absence of reference to the exclusion of a part or a clause of a general part
means that the corresponding clauses of the general part are applicable (undated
references).
Requirements of other 7XX parts being relevant for installations covered by this part also
apply. This part may therefore also supplement, modify or replace certain of these
requirements valid at the time of publication of this part.
The clause numbering of this part follows the pattern and corresponding references of
IEC 60364. The numbers following the particular number of this part are those of the
corresponding parts, or clauses of the other parts of the IEC 60364 series, valid at the time of
publication of this part, as indicated in the normative references of this document (dated
references).
If requirements or explanations additional to those of the other parts of the IEC 60364 series
are needed, the numbering of such items appears as 710.101, 710.102, 710.103, etc.
In the case where new or amended general parts with modified numbering were published
after this part was issued, the clause numbers referring to a general part in this Part 710 may
no longer align with the latest edition of the general part. Dated references should be
observed.
The particular requirements of this document apply to the electrical installations in medical
locations.
The clause numbering following 710 are those of the corresponding parts or clauses of
IEC 60364. The absence of reference to a part or a clause means that all parts of IEC 60364
are applicable.
In medical locations patients are likely to be subjected to the application of medical electrical
(ME) equipment. Measures for the safety of patients and medical staff need to be enhanced
due to:
i) the reduction in body resistance, since the skin is often cut or broken;
ii) the risk associated with loss of supply, especially to life supporting equipment;
iii) the increased risk of electric shock due to the presence of liquids, such as blood,
saline and water (e.g. for irrigation).
Items (i) and (ii) affect the patient, whereas item (iii) affects the patient and medical staff.
For every activity and function in a medical location, the particular requirements for safety,
including protection against electric shock and continuity of supply, need to be considered.
Safety can be achieved by the application of this document and the safe operation and
maintenance of ME equipment.
– 6 – IEC 60364-7-710:2021 © IEC 2021
Variations of this document to further enhance safety and reliability are acceptable.
Annex C provides a statement about the inclusion of text concerning particular conditions that
are existing in certain countries and that state exceptions to the respective subclauses.
IEC 60364-7-710:2021 © IEC 2021 – 7 –
LOW-VOLTAGE ELECTRICAL INSTALLATIONS –
Part 7-710: Requirements for special installations or locations –
Medical locations
710 Medical locations
710.1 Scope
The particular requirements of this part of IEC 60364 apply to electrical installations in
medical locations so as to provide safety of patients and medical staff. These requirements
refer to:
– hospitals and clinics or equivalent institutions (including equivalent transportable and
mobile locations);
which, subject to assessment (710.30), can also include:
– sanatoriums and health clinics;
– dedicated locations in homes for senior citizens and aged care homes, where patients
receive medical care;
– medical centres, outpatients' clinics and departments, casualty wards;
– other outpatients' institutions (industrial, sports and others);
– medical and dental practices;
– dedicated medical rooms in the workplace;
– other locations where medical electrical equipment is used;
– veterinary clinics;
– rooms in existing installations where a change of utilization for medical applications occur.
This list is not exhaustive.
The requirements of this document do not apply to ME equipment or ME systems.
NOTE 1 ME equipment and ME systems are covered by IEC 60601 (all parts).
® ®
NOTE 2 In the USA, the requirements of NFPA 70 , National Electrical Code in general and specifically article
517 (Healthcare Facilities) apply.
710.2 Normative references
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.
IEC 60050-826, International Electrotechnical Vocabulary – Part 826: Electrical installations
(available at http://www.electropedia.org)
IEC 60364-1:2005, Low-voltage electrical installations – Part 1: Fundamental principles,
assessment of general characteristics, definitions
IEC 60364-4-41:2005, Low-voltage electrical installations – Part 4-41: Protection for safety –
Protection against electric shock
IEC 60364-4-41:2005/AMD1:2017
– 8 – IEC 60364-7-710:2021 © IEC 2021
IEC 60364-4-42:2010, Low-voltage electrical installations – Part 4-42: Protection for safety –
Protection against thermal effects
IEC 60364-4-42:2010/AMD1:2014
IEC 60364-4-44:2007, Low-voltage electrical installations – Part 4-44: Protection for safety –
Protection against voltage disturbances and electromagnetic disturbances
IEC 60364-4-44:2007/AMD1:2015
IEC 60364-4-44:2007/AMD2:2018
IEC 60364-5-51:2005, Electrical installations of buildings – Part 5-51: Selection and erection
of electrical equipment – Common rules
IEC 60364-5-52:2009, Low-voltage electrical installations – Part 5-52: Selection and erection
of electrical equipment – Wiring systems
IEC 60364-5-53:2019, Low-voltage electrical installations – Part 5-53: Selection and erection
of electrical equipment – Devices for protection for safety, isolation, switching, control and
monitoring
IEC 60364-5-53:2019/AMD1:2020
IEC 60364-5-56:2018, Low-voltage electrical installations – Part 5-56: Selection and erection
of electrical equipment – Safety services
IEC 60364-6:2016, Low voltage electrical installations – Part 6: Verification
IEC 60947-6-1, Low-voltage switchgear and controlgear – Part 6-1: Multiple function
equipment – Transfer switching equipment
IEC 61439 (all parts), Low-voltage switchgear and controlgear assemblies
IEC 61557-8:2014, Electrical safety in low voltage distribution systems up to 1 000 V a.c. and
1 500 V d.c. – Equipment for testing, measuring or monitoring of protective measures –
Part 8: Insulation monitoring devices for IT systems
IEC 61557-9:2014, Electrical safety in low voltage distribution systems up to 1 000 V a.c. and
1 500 V d.c. – Equipment for testing, measuring or monitoring of protective measures –
Part 9: Equipment for insulation fault location in IT systems
IEC 61558-2-15, 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
710.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60050-826,
IEC 60364-1 and the following apply.
ISO and IEC maintain terminological 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
710.3.1
medical location
location intended for purposes of diagnosis, treatment, monitoring and care of patients
IEC 60364-7-710:2021 © IEC 2021 – 9 –
710.3.2
patient
living being (person or animal) undergoing a medical, surgical or dental procedure
[SOURCE: IEC 60601-1:2005, 3.76, modified – The note has been deleted.]
710.3.3
medical electrical equipment
ME equipment
electrical equipment having an applied part or transferring energy to or from the patient or
detecting such energy transfer to or from the patient and which is
a) provided with not more than one connection to a particular supply mains, and
b) intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a
patient, or for compensation or alleviation of disease, injury or disability
Note 1 to entry: ME equipment includes those accessories as defined by the manufacturer that are necessary to
enable the normal use of the ME equipment.
[SOURCE: IEC 60601-1:2005, 3.63, modified – Notes 2, 3, 4 and 5 have been deleted.]
710.3.4
applied part
part of ME equipment that in normal use necessarily comes into physical contact with the
patient for ME equipment or an ME system to perform its function
[SOURCE: IEC 60601-1:2005, 3.8, modified – The notes have been deleted.]
710.3.5
medical electrical system
ME system
combination, as specified by its manufacturer, of items of equipment, at least one of which is
ME equipment to be inter-connected by functional connection or by use of a multiple socket-
outlet
[SOURCE: IEC 60601-1:2005, 3.64, modified – The note has been deleted.]
710.3.6
patient environment
any volume in which intentional or unintentional contact can occur between a patient and
parts of the ME equipment or ME system or between a patient and other persons touching
parts of the ME equipment or ME system
Note 1 to entry: For illustration see Figure 710.1.
Note 2 to entry: This applies where the patient's position is pre-determined.
[SOURCE: IEC 60601-1:2005, 3.79, modified – The notes have been added.]
710.3.7
group 0
medical location where ME equipment or ME systems are not intended to be used
710.3.8
group 1
medical location where ME equipment or ME systems are intended to be used externally or
invasively on any part of the patient and where discontinuity of the electrical supply, such as
protection against electric shock, does not represent a risk to the safety of the patient
– 10 – IEC 60364-7-710:2021 © IEC 2021
710.3.9
group 2
medical location where ME equipment or ME systems are intended to be used intrusively,
externally or invasively to any part of the patient and where discontinuity of the electrical
supply, such as protection against electric shock, represents a risk to the safety of the patient
710.3.10
medical IT system
electric IT system fulfilling all specific additional requirements of group 2 medical locations
Note 1 to entry: All specific requirements for medical locations of group 2 are reflected.
710.3.11
main distribution board
distribution board that fulfils all the functions of a main electrical distribution for the supplied
area assigned to it and where the voltage is measured for operating the electric supply
system for safety services
710.3.12
electric source for safety services
electric source intended to be used as part of an electric supply system for safety services
[SOURCE: IEC 60050-826:2004, 826-10-05]
710.3.13
medical insulation monitoring device
MED-IMD
specific insulation monitoring device (IMD) dedicated to monitor medical IT systems
[SOURCE: IEC 61557-8:2014, 3.1.22, modified – "of a group 2 medical location" has been
deleted]
710.3.14
insulation fault location system
IFLS
device or combination of devices used for insulation fault location in IT systems, where the
insulation fault location system is used in addition to an insulation monitoring device and is
used to locate insulation faults
Note 1 to entry: An IFLS injects a locating current between the electrical system and earth.
[SOURCE: IEC 61557-9:2014, 3.1.1]
710.3.15
uninterruptible power system
UPS
combination of convertors, switches and energy storage devices (such as batteries),
constituting a power system for maintaining continuity of load power in case of input power
failure
Note 1 to entry: Continuity of load power occurs when voltage and frequency are within rated steady-state and
transient tolerance bands, and with distortion and interruptions within the limits specified for the output port. Input
power failure occurs when voltage and frequency are outside rated steady-state and transient tolerance bands, or
with distortion or interruptions outside the limits specified for the UPS.
[SOURCE: IEC 62040-1:2017, 3.101]
IEC 60364-7-710:2021 © IEC 2021 – 11 –
710.30 Assessment of general characteristics
Add:
The designer, in conjunction with medical staff and the person(s) responsible for medical
safety, shall consider what effects discontinuity of the electric supply will have on the ME
equipment or ME systems including:
– the duration of the discontinuity (failure) of the electrical supply;
– the effect of any supply interruption on the treatment, monitoring or examination, including
if any procedure repetition is hazardous to the patient or if it is impossible to repeat the
examination results.
A comprehensive assessment shall be performed to identify the proper electrical supply
requirements for the ME equipment, ME systems and supporting electrical equipment
intended to be used.
Having identified these requirements, the appropriate classification for the medical location
shall be determined. In order to determine the extent of a medical location, all possible patient
positions shall be considered.
Where assessment shows any given location that falls into both group 1 or group 2
categories, the location shall be classified as group 2.
NOTE 1 For the classification of electric supply systems for safety services, see IEC 60364-5-56 and 710.560.4.1.
NOTE 2 Guidance on the allocation of a group number and classification of electric supply systems for safety
services for medical locations is shown in Annex A.
710.31 Purposes, supplies and structure
710.312.2 Types of system earthing
Add:
A TN-C system shall not be used downstream of the main distribution board.
710.313 Supplies
710.313.1 General
Add:
710.313.1.101 Supplies for electric supply systems for safety services and standby
systems in medical locations of group 1 and group 2
In medical locations of group 1 and group 2, the distribution system shall be designed and
installed to facilitate the automatic transfer switching or automatic change-over equipment
from the main distribution network to the electric source for safety services feeding essential
loads (see IEC 60364-5-56). Consideration shall be given to all other essential medical and
non-medical loads.
Consideration should also be given to the inrush current of any connected equipment.
NOTE This could also apply to group 0 medical locations.
– 12 – IEC 60364-7-710:2021 © IEC 2021
710.313.1.102 Power supply for medical locations of group 2
In case of a single fault in the power supply, a total loss of power shall be prevented. This
may be achieved by:
– provision of two independent supply lines, and/or
• a UPS within the same fire section for supplying the medical IT system, or
• a UPS that supplies a number of group 2 locations.
710.314 Division of installation
Add:
710.314.101
Final circuits for ME equipment and ME systems shall be for the exclusive use of such
equipment.
710.41 Protection for safety – Protection against electric shock
710.410.3 General requirements
710.410.3.5
Replace with:
The protective measures of "obstacles" and "placing out of reach" shall not be used.
710.410.3.6
Replace with:
The protective measures of "non-conducting location", "protection by earth-free local
equipotential bonding" and "electrical separation for the supply of more than one item of
current-using equipment", shall not be used.
710.411 Protective measure: automatic disconnection of supply
710.411.3 Requirements for fault protection
710.411.3.2 Automatic disconnection in case of a fault
710.411.3.2.5
Replace with:
In medical locations of group 1 and group 2, where disconnection of the power supply cannot
be achieved either by means of an overcurrent protection device in accordance with
IEC 60364-4-41:2005, 411.3.2 and IEC 60364-4-41:2005/AMD1:2017, 411.3.2 or by means of
a residual current protective device (RCD), the following applies.
– For IT, TN and TT systems, the permissible touch voltage U shall not exceed 25 V AC
L
(U ≤ 25 V AC) or 60 V DC (U ≤ 60 V DC).
L L
– In TN systems, 25 V AC (U ≤ 25 V AC) or 60 V DC (U ≤ 60 V DC) can be maintained
L L
using supplementary protective equipotential bonding.
The provisions described in IEC 60364-4-41:2005/AMD1:2017, Annex D, shall not be applied.
IEC 60364-7-710:2021 © IEC 2021 – 13 –
710.411.3.3 Further requirements for socket-outlets and for the supply of mobile
equipment for use outdoors
Add:
Where a medical IT system is used, additional protection by means of a residual current
protective device (RCD) shall not be used.
710.411.4 TN system
710.411.4.5
Add:
In group 1 and group 2 medical locations, protection with residual current protective devices
(RCDs) for TN circuits shall be in accordance with IEC 60364-4-41:2005/AMD:2017, 411.3.2.
710.411.5 TT system
710.411.5.2
Add:
In medical locations of group 1 or group 2, residual current protective devices (RCDs) for TT
circuits shall be in accordance with IEC 60364-4-41:2005, 411.3.2 and
IEC 60364-4-41:2005/AMD1:2017, 411.3.2.
710.411.6 IT system
Add:
710.411.6.1.101 Medical IT systems
In group 2 medical locations, a medical IT system, including the requirements of
710.411.6.3.101 and 710.512.1.101, shall be used for final circuits and where the same final
circuit is connected to ME equipment or an ME system, located within the patient
environment. Exceptions can be made for final circuits for
– equipment with a rated power greater than 5 kVA,
– X-ray equipment,
– the supply of the motors of fixed operating tables.
In medical locations of group 2, the supply to final circuits for socket-outlets for ME equipment
and ME systems used for life-support of the patient, shall not be automatically disconnected
in the event of a first fault.
710.411.6.3.101 Medical insulation monitoring device
The medical IT system shall be equipped with a medical insulation monitoring device (MED-
IMD) in accordance with IEC 61557-8:2014, Annex A and Annex B.
NOTE 1 In addition to information given by a remote insulation warning, the following events could be constantly
displayed:
– status of the power supply lines for medical locations of group 2;
– circuit breaker tripping;
– other disorders that are important for the operation of the medical location;
– malfunction of communication systems;
with the possibility to forward all information to technical staff.
– 14 – IEC 60364-7-710:2021 © IEC 2021
An indelible and easily readable written explanation shall be provided in the medical location,
which includes the meaning of each type of signal, alarm and the procedures to be followed in
case of a first fault.
For transformers in accordance with IEC 61558-2-15 supplying a medical IT system,
monitoring of overload and over temperature conditions shall be applied.
In a medical IT system, it is recommended to use an IFLS.
Where an insulation fault location system is installed, it shall be in accordance with
IEC 61557-9:2014, Annex A.
NOTE 2 An IFLS eases the location of the faults, especially in case of intermittent faults.
710.414 Protective measure: extra-low-voltage provided by SELV and PELV
710.414.1 General
Add:
710.414.1.101 If SELV and/or PELV circuits in medical locations of group 1 and group 2 are
used, the nominal voltage applied to current-using equipment shall not exceed 25 V RMS AC
or 60 V ripple free DC. Protection by basic insulation of live parts in accordance with
IEC 60364-4-41:2005, Clause A.1 or by barriers or enclosures in accordance with
IEC 60364-4-41:2005, Clause A.2 shall be provided.
NOTE Ripple-free is conventionally defined as an RMS ripple voltage of not more than 10 % of the DC
component.
710.414.4 Requirements for SELV and PELV circuits
710.414.4.1
Add:
In medical locations of group 1 and group 2, where PELV is used, exposed-conductive-parts
of equipment shall be connected to the equipotential bonding busbar via a protective bonding
conductor.
710.415 Additional protection
710.415.2 Additional protection: supplementary protective equipotential bonding
Add:
710.415.2.101
In each medical location of group 1 and group 2, a supplementary protective equipotential
bonding system shall be installed, and the supplementary protective bonding conductors shall
be connected to the equipotential bonding busbar for the purpose of equalizing potential
differences between the following parts located within the patient environment:
– extraneous-conductive-parts, unless they are intended to be isolated from earth;
– screens against electrical interference fields, if installed;
– connection to conductive floor grids, mesh and tapes, including those for static protection,
if installed;
– metal screens of isolating transformers, cable shields, etc., via the direct path to the
protective earthing conductor;
IEC 60364-7-710:2021 © IEC 2021 – 15 –
Conductive parts intended to be isolated from earth shall not be connected to supplementary
protective equipotential bonding.
Supplementary equipotential bonding connection points for the connection of ME equipment
shall be available in group 2 locations and considered in group 1.
710.415.2.102
In medical locations of group 1 and group 2, the resistance between simultaneously
accessible exposed-conductive-parts, including the terminals for the protective conductor of
socket-outlets and of fixed equipment, extraneous conductive parts and the equipotential
bonding points shall be of such a value to meet the requirements of 710.411.3.2.5 and shall
not exceed 0,2 Ω.
NOTE The limit of 0,2 Ω is based on the use of a type B miniature circuit breaker rated current of 25 A to achieve
the conventional touch voltage of 25 V AC.
National regulations may require other values.
710.415.2.103
The equipotential bonding busbar shall be located within or near each medical location of
group 1 and group 2. Connections shall be so arranged that they are accessible, labelled,
clearly visible and that they can easily be individually disconnected.
710.42 Protection for safety – Protection against thermal effects
710.421 Protection against fire caused by electrical equipment
710.421.1 General requirements
Add:
710.421.7.101
Arc fault detection devices (AFDDs) shall not be used in circuits supplied by IT systems
specified as medical IT systems in 710.411.6.
In circuits not supplied by medical IT systems, any use of an arc fault detection device
(AFDD) shall be subject to a risk assessment.
NOTE Risk assessments could involve the participation of fire inspectors, designers, architects and stakeholders.
Additional national legislation shall be observed.
710.44 Protection for safety – Protection against voltage disturbances and
electromagnetic disturbances
710.444 Measures against electromagnetic influences
710.444.1 General
Add:
Special consideration shall be given to electromagnetic interference and electromagnetic
compatibility. Further information is provided in Annex B.
NOTE Information about electrostatic control in healthcare can be found in IEC 61340 (all parts).
– 16 – IEC 60364-7-710:2021 © IEC 2021
710.51 Selection and erection of electrical equipment – Common rules
Add:
710.51.101 Distribution boards
710.51.101.1 General
Distribution boards shall be in accordance with IEC 61439 (all parts).
Separate distribution boards shall be provided for the general power supply and the electric
supply system for safety services.
710.51.101.2 Medical locations of group 2
Distribution boards for group 2 medical locations shall be installed in close proximity to the
areas they serve and be clearly labelled. Distribution boards shall be installed outside the
group 2 medical locations and should be safely secured against operation by unauthorized
persons.
The medical IT distribution board should be located within 25 m of the area it serves. Leakage
currents should be taken into consideration.
NOTE 1 The 25 m are related to possible capacitive leakage current.
Recommendations for the minimum distances from the isolating transformers of the medical
IT system to the equipment used within the patient environment are shown in informative
Annex B.
The distribution board should be easily accessible for maintenance and be located on the
same level and within the same fire compartment as the load it serves.
NOTE 2 A distribution board for medical locations is one that fulfils the functions for the supplied medical location
area assigned to it and where the main power supply voltage is monitored for operating the change-over to the
electric supply system for safety services in accordance with 710.313.1.101 and 710.313.1.102.
710.51.102 Electrical operating areas
Where electrical operating areas are provided, national regulations prevail. If no national
regulations are available the following arrangements, if any, shall each be accommodated in
their own enclosed electrical operating a
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