SIST HD 60364-7-710:2025/A11:2025

SLOVENSKI STANDARD
01-december-2025
Nizkonapetostne električne inštalacije - 7-710. del: Zahteve za posebne inštalacije
ali lokacije - Medicinski prostori - Dopolnilo A11
Low voltage electrical installations - Part 7-710: Requirements for special installations or
locations - Medical locations
Errichten von Niederspannungsanlagen - Teil 7-710: Anforderungen für Betriebsstätten,
Räume und Anlagen besonderer Art - Medizinisch genutzte Bereiche
Installations électriques à basse tension - Partie 7-710: Règles pour les installations ou
emplacements spéciaux - Locaux à usages médicaux
Ta slovenski standard je istoveten z: HD 60364-7-710:2025/A11:2025
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 60364-7-710:2025/A11

DOCUMENT D'HARMONISATION
HARMONISIERUNGSDOKUMENT October 2025
ICS 91.140.50; 29.020
English Version
Low-voltage electrical installations - Part 7-710: Requirements
for special installations or locations - Medical locations
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
This amendment A11 modifies the Harmonization Document HD 60364-7-710:2025; it was approved by CENELEC on 2021-04-19.
CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for implementation of
this amendment 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 amendment 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/A11:2025 E

Contents Page
European foreword . 3
1 Addition of normative Annex ZA, "Normative references to international publications with their
corresponding European publications" . 4
2 Addition of normative Annex ZB "Special national conditions" . 6
3 Addition of informative Annex ZC "A-deviations" . 20
European foreword
This document (HD 60364-7-710:2025/A11:2025) has been prepared by CLC/TC 64 "Electrical
installations and protection against electric shock".
The following dates are fixed:
• latest date by which this document has (dop) 2026-10-31
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2028-10-31
standards conflicting with this document
have to be withdrawn
This document modifies HD 60364-7-710:2025.
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.
1 Addition of normative Annex ZA, "Normative references to international
publications with their corresponding European publications"
Add the following Annex ZA:
“
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.
Publication Year Title EN/HD Year
IEC 60050-826 -  International Electrotechnical Vocabulary – - -
Part 826: Electrical installations
IEC 60364-1 (mod) 2005 Low-voltage electrical installations – Part HD 60364-1 2008
1: Fundamental principles, assessment of
general characteristics, definitions
+ A11 2017
IEC 60364-4-41 2005 Low-voltage electrical installations – HD 60364-4-41 2017
Part 4-41: Protection for safety –
Protection against electric shock
+ A1 2017
+ A11 2017
+ A12 2019
IEC 60364-4-42 2010 Low-voltage electrical installations – Part HD 60364-4-42 2011
(mod) 4-42: Protection for safety – Protection
against thermal effects
+ A1 2014 + A1 2015
IEC 60364-4-44 2007 Low-voltage electrical installations – Part HD 60364-4-442 2012
(mod) 4-44: Protection for safety – Protection HD 60364-4-444 2010
against voltage disturbances and
electromagnetic disturbances
+ A1 (mod) 2015 HD 60364-4-443 2016
+ A2 2018 - -
IEC 60364-5-51 2005 Electrical installations of buildings – Part 5- HD 60364-5-51 2009
(mod) 51: Selection and erection of electrical
equipment – Common rules
+ A11 2013
Publication Year Title EN/HD Year
+ A12 2017
IEC 60364-5-52 2009 Low-voltage electrical installations – Part HD 60364-5-52 2011
5-52: Selection and erection of electrical
equipment – Wiring systems
- - + A11 2017
IEC 60364-5-53 2019 Low-voltage electrical installations – Part - -
5-53: Selection and erection of electrical
equipment – Devices for protection,
isolation, switching, control and monitoring
+ A1 2020 - -
IEC 60364-5-56 2018 Low-voltage electrical installations – HD 60364-5-56 2018
Part 5-56: Selection and erection of
electrical equipment – Safety services
IEC 60364-6 2016 Low voltage electrical installations – HD 60364-6 2016
Part 6: Verification
+ A11 2017
+ A12 2017
IEC 60947-6-1 - Low-voltage switchgear and controlgear – EN 60947-6-1 2005
Part 6-1: Multiple function equipment –
Transfer switching equipment
- - + A1 2014
IEC 61439 series Low-voltage switchgear and controlgear EN IEC 61439 series
assemblies
IEC 61557-8 2014 Electrical safety in low voltage distribution EN 61557-8 2015
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 EN 61557-9 2015
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 EN 61558-2-15 2012
supply units and combinations thereof –
Part 2-15: Particular requirements and
tests for isolating transformers for the
supply of medical locations
“
2 Addition of normative Annex ZB "Special national conditions"
Add the following Annex ZB:
“
Annex ZB
(normative)
Special national conditions
Special national conditions: National characteristic or practice that cannot be changed even over a
long period, e. g. climatic conditions, electrical earthing conditions.
NOTE If it affects harmonization, it forms part of the European Standard or Harmonization Document.
For the countries in which the relevant special national conditions apply these provisions are
normative, for other countries they are informative.
Clause Special national condition
710.1 Austria
In Austria, national requirements apply to medical locations outside hospitals for
example:
– medical and dental practices,
– for dedicated locations in homes for senior citizens and aged care, where the
patients are subjected to medical care;
– rooms in existing installations where a change of utilization for medical
applications occur.
710.3.7 United Kingdom
In the United Kingdom, this definition for ‘group 0’ reads as follows:
medical location where ME equipment or ME systems are not intended to be
applied and where discontinuity of the electrical supply does not represent a risk
to the safety of the patient
710.3.7 Ireland
In Ireland, this definition for ‘group 0’ reads as follows:
medical location where ME equipment or ME systems are not intended to be used
and where discontinuity of the electrical supply does not represent a risk to the
safety of the patient
710.3.8 United Kingdom
In the United Kingdom, this definition for ‘group 1 medical location’ reads as
follows:
medical location where ME equipment or ME systems are intended to be applied
for treatment or diagnosis of a patient and where discontinuity of the electrical
supply does not represent a risk to the safety of the patient
Note 1 to entry: Generally, ME equipment and ME systems are applied externally,
intrusively or invasively.
Note 2 to entry: Discontinuity of the electrical supply may be as an interruption of
the electrical service, or by the application of protective measures against electric
shock.
Clause Special national condition
710.3.8 Ireland
In Ireland, this definition for ‘group 1’ reads as follows:
medical location where ME equipment or ME systems are intended to be used
and where discontinuity of the electrical supply does not represent a risk to the
safety of the patient
Note 1 to entry: Generally, ME equipment and ME systems can be applied
externally, intrusively or invasively.
Note 2 to entry: Discontinuity of the electrical supply may occur due to an
interruption of the electrical service, or by the application of protective measures
against electric shock
710.3.8 Sweden
In Sweden, this is rephrased:
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 does not represent a risk to the safety of the patient
Note 1 to entry: In group 1 locations can for example automatic disconnection of
supply be applied in case of a first fault.
710.3.8 The Netherlands
In the Netherlands, intracardiac treatments are not allowed in group 1 locations.
710.3.8 The Netherlands
In the Netherlands, this subclause reads as follows:
group 1
medical location where a discontinuity (disturbance) of de electrical supply does
not form a threat to the safety of the patient and which is intended to be used for
the following applied parts:
- Externally
- Internally in any part of the body, with the exception of instances where group 2
is applicable
710.3.9 United Kingdom
In the United Kingdom, this definition for ‘group 2 medical location’ reads as
follows:
medical location where ME equipment or ME systems are intended to be applied
for treatment or diagnosis of a patient and where discontinuity of the electrical
supply represents a risk to the safety of the patient
Note 1 to entry: Generally, ME equipment and ME systems are applied externally,
intrusively or invasively.
Note 2 to entry: Discontinuity of the electrical supply may be as an interruption of
the electrical service, or by the application of protective measures against electric
shock.
Note 3 to entry: Risk to patient safety includes where the ME Equipment or ME
Systems provide patient life-support functions.
Clause Special national condition
710.3.9 Ireland
In Ireland, this definition for ‘group 2' reads as follows:
medical location where ME equipment or ME systems are intended to be used
and where discontinuity of the electrical supply represents a risk to the safety of
the patient
Note 1 to entry: Generally, ME equipment and ME systems can be applied
externally, intrusively or invasively.
Note 2 to entry: Discontinuity of the electrical supply may occur due to an
interruption of the electrical service, or by the application of protective measures
against electric shock.
Note 3 to entry: Risks to patient safety include where the ME Equipment or ME
Systems provide life-support functions.
710.3.9 The Netherlands
In the Netherlands, this subclause reads as follows:
group 2
medical location intended for the use of applied parts for the following
applications:
- Actions reaching into or nearby the heart, including the major heart vessels, or
- Vital actions or operations where a discontinuity of the electrical supply
represents a risk to the safety of the patient.
710.30 The Netherlands
In the Netherlands, the allocation of group numbers and classification of safety
services to a medical location shall be made in agreement with the medical staff
and the person(s) responsible for the medical safety. In order to determine the
classification of a medical location, it is necessary that the medical staff indicate
which medical procedures will take place within the location. Based on the
intended use, the appropriate classification for the location shall be determined.
710.313.1.102 United Kingdom
In the United Kingdom, this subclause reads as follows:
In case of a single fault in the power supply, a total loss of power shall be
prevented. This may be achieved by the provision of two independent supply
lines, and either:
- an uninterruptable power system (UPS) within the same fire section for
supplying the medical IT system, or
- an UPS that supplies a number of group 2 locations.
710.313.1.102 Germany
In Germany, this subclause reads as follows:
In the case of a single fault, a total power failure shall be prevented. This can be
achieved by providing two independent power supplies.
710.313.1.102 Austria
In Austria, the following paragraph is added:
In Austria, to ensure operational safety of power supply for medical locations of
group 2, each section of a distribution board of the medical IT systems supplied
with electric sources for safety services, in accordance with 710.560.6.103.1,
shall be supplied with an ATSE in accordance with 710.536.101 via two
independent supply lines. The preferred supply line shall be via the electric
source for safety services in accordance with 710.560.6.103.1, the second line via
the electric source for safety services in accordance with 710.560.6.103.2.
710.313.1.102 Norway
In Norway, the second sentence and the subsequent three dashes do not apply.
Clause Special national condition
710.313.1.102 The Netherlands
In the Netherlands, the wording “within the same fire section” is removed.
710.313.1.102 Ireland
In Ireland this sub-clause should read as follows:
In case of a single fault in the power supply, a total loss of power shall be
prevented. This may be achieved by the provision of two independent supply
lines, and either
- an uninterruptable power system (UPS) within the same fire section for
supplying the medical IT system, or
– an uninterruptable power system (UPS) that supplies a number of group 2
locations.
710.314.101 The Netherlands
In the Netherlands, this subclause reads as follows:
Final circuits for ME equipment and ME systems shall be for the exclusive use of
such equipment unless a risk assessment has shown otherwise.
710.411.6.1.101 The Netherlands
In the Netherlands, this subclause reads as follows:
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:
- circuits for the supply of movements of fixed operating tables;
- circuits for fixed X-ray units;
- circuits for fixed ME equipment where skin contact is possible;
- circuits for fixed equipment other than medical electrical equipment;
- circuits for large equipment with a rated power greater than 5 kVA.
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.
A Medical IT system shall only supply one location.
If, based on risk assessment, it can be concluded that two adjacent locations can
be considered as one location; a medical IT system may supply both locations.
710.411.6.1.102 The Netherlands
In case of a medical IT system, the leakage current of the secondary circuit shall
not be larger than 500 μA.
The requirement is not applicable to circuits solely intended for the supply of fixed
installed equipment.
710.411.6.1.103 The Netherlands
A medical IT system intended for the supply of socket outlets for general use shall
be limited in power to maximum 3,3 kVA.
710.410.3.5 Germany
In Germany, this subclause does not apply.
710.411.3.2.5 Belgium
In Belgium, the disconnection times are fixed by regulations.
710.411.3.3 Belgium
In Belgium, for medical locations group 2, the number of additional equipotential
bonding terminals should be at least equal to the number of installed power
outlets.
Clause Special national condition
710.411.3.2.5 United Kingdom
In the United Kingdom, this clause reads as follows:
In medical locations of group 1 and group 2, the following shall apply
— for IT, TN and TT systems, the permissible touch voltage U shall not exceed
L
25 V AC (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
L L
maintained using supplementary protective equipotential bonding.
IEC 60364-4-41:2005 and IEC 60364-4-41:2005/AMD1:2017, Annex D, is not
applicable.
710.411.6.1.101 Norway
In Norway, 710.411.6.1.101 does not apply. Instead, the following clause
710.313.1.103 applies:
710.313.1.103 Medical IT system
In group 2 medical locations, a medical IT system, shall be used to supply:
– ME equipment and/or ME system, located within the patient environment.
– ME equipment and ME systems used for life-support
The requirements do not apply to circuits supplying:
– equipment with a rated power greater than 5 kVA;
– X-ray equipment;
– motors of fixed operating tables.
For the medical IT system, the requirement of IT systems applies.
710.411.6.1.101 The Netherlands
In the Netherlands, X-ray equipment is limited to fixed X-ray equipment.
710.411.6.1.101 United Kingdom
In the United Kingdom, this subclause has the following addition:
The total leakage current without load, including the medical IT transformer, of all
circuits connected to a medical IT system shall be considered.
It is recommended that the capacitive leakage current is not greater than 10 mA.
710.411.6.1.101 Ireland
In Ireland, this sub-clause has the following addition:
The total leakage current of all circuits connected to a medical IT system, under
no-load conditions, and including isolating transformers, shall be considered.
It is recommended that the capacitive leakage current is not greater than 10 mA.
Clause Special national condition
710.411.6.3.101 The Netherlands
In the Netherlands, this subclause reads as follows:
The medical IT system shall be equipped with an insulation monitoring device
(IMD) in accordance with EN 61557-8:2007 with the following additional specific
requirements:
a) the internal impedance shall be ≥500 kΩ;
b) the test voltage shall be AC with a frequency of about 50 Hz and a value ≤25
V;
c) the injected current, even under fault conditions, shall be ≤500 μA peak;
Every medical IT-system shall be equipped with an acoustic and optical alarm
system. This alarm system shall be installed in a suitable location such that it can
be continuously monitored by medical and technical staff.
The following components shall be included:
- A green signal lamp for indicating normal operation;
- A red or yellow signal lamp which lights when the minimum value set for the
insulation resistance is reached or if the overload and overtemperature of the
medical isolation transformers occurs. It shall not be possible for this signal lamp
to be cancelled or disconnected.
- An acoustic alarm which sounds when the minimum value set for the insulation
resistance is reached or if the overload and overtemperature of the medical
isolation transformers occurs. This acoustic alarm may be silenced.
- The red or yellow signal lamp shall extinguish on removal of the fault and when
normal operation is restored.
A written explanation shall be easily readable in the medical location and it shall
include: the meaning of each type of signalization, 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 insulation fault location
system (IFLS). Where an insulation fault location system is installed, it shall be in
accordance with IEC 61557-9:2014, Annex A.
710.415.101 The Netherlands
Additional protection: isolation from the building construction
In medical locations extraneous-conductive-parts and fixed accessible metal parts
of the installation shall isolated from the building construction. The impedance of
all these parts together shall be at least 3 kΩ.
710.415.2.102 Finland
In Finland, the requirement of resistance of 0,2 Ω applies only to group 2
locations.
Germany
In Germany, in medical locations of group 1 and group 2, the electrical resistance
of the protective conductors, including the electrical resistance of the connections
between the distributor for the protective conductors of the sockets and
permanently connected equipment or any other conductive parts and the
protective potential equalization rail, is not specified.

Switzerland
In Switzerland, in medically locations of group 1 and group 2, the resistance of the
...