Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations

Applies to electrical installations in medical locations so as to ensure safety of patients and medical staff. These requirements, in the main, refer to hospitals, private clinics, medical and dental practices, health care centres and dedicated medical rooms in the work place.

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

Les prescriptions sont applicables à des installations électriques de locaux à usages médicaux afin d'assurer la sécurité des patients et du personnel médical. Ces prescriptions se réfèrent généralement à des hôpitaux, des cliniques privées, des cabinets médicaux et dentaires, des centres de soins et à des locaux médicaux sur des sites de travail.

Nizkonapetostne električne inštalacije - 7-710. del: Zahteve za posebne inštalacije ali lokacije - Medicinski prostori (IEC 60364-7-710:2002, spremenjen)

Posebne zahteve tega dela standarda HD 60364 se uporabljajo za električne inštalacije v medicinskih prostorih, da se zagotovi varnost pacientov in zdravniškega osebja. Te zahteve se nanašajo predvsem na bolnišnice, zasebne klinike, zdravstvene in zobozdravstvene ambulante, zdravstvene domove ter namenske medicinske prostore na delovnem mestu. Zahteve tega dela se ne uporabljajo za medicinsko električno opremo. Ta del se uporablja tudi za električne inštalacije v prostorih, namenjenih medicinskim raziskavam.
OPOMBA 1: Morda je treba spremeniti obstoječo električno inštalacijo v skladu s tem standardom,
kadar pride do spremembe rabe prostora. Posebna pozornost naj se nameni izvajanju kardioloških posegov
v obstoječih inštalacijah.
OPOMBA 2: Ta standard se lahko po potrebi uporablja tudi za veterinarske klinike.
OPOMBA 3: Za medicinsko električno opremo in medicinske električne sisteme glejte skupino standardov EN 60601.
OPOMBA 4: Paziti je treba, da druge inštalacije ne vplivajo negativno na inštalacije.
OPOMBA 5: Te zahteve se na primer uporabljajo za električne inštalacije za medicinske prostore v:
– bolnišnicah in klinikah (vključno z zasnovo zabojnika);
– sanatorijih in zdravstvenih klinikah;
– namenskih prostorih v domovih za starejše občane in oskrbo starostnikov, kjer so pacienti deležni zdravstvene oskrbe;
– medicinskih centrih, ambulantah in oddelkih, nezgodnih oddelkih;
– drugih ambulantnih ustanovah (industrijskih, športnih in drugih).
OPOMBA 6: Uporaba tega harmonizacijskega dokumenta ne izključuje upoštevanja nacionalnih predpisov.

General Information

Status
Published
Publication Date
08-Mar-2012
Current Stage
6060 - Document made available - Publishing
Due Date
09-Jul-2012
Completion Date
09-Mar-2012

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Standardization document
HD 60364-7-710:2012
English language
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Standards Content (Sample)


SLOVENSKI STANDARD
01-maj-2012
1DGRPHãþD
SIST IEC 60364-7-710:2006
1L]NRQDSHWRVWQHHOHNWULþQHLQãWDODFLMHGHO=DKWHYH]DSRVHEQHLQãWDODFLMH
DOLORNDFLMH0HGLFLQVNLSURVWRUL ,(&VSUHPHQMHQ
Low-voltage electrical installations - Part 7-710: Requirements for special installations or
locations - Medical locations
Errichten von Niederspannungsanlagen - Teil 7-710: Anforderungen für spezielle
Installationen oder Standorte - Medizinische Standorte und zugehörige 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 60364-7-710:2012
ICS:
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SULSRPRþNLQDVSORãQR
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
March 2012
HARMONISIERUNGSDOKUMENT
ICS 29.020; 91.140.50
English version
Low-voltage electrical installations -
Part 7-710: Requirements for special installations or locations -
Medical locations
(IEC 60364-7-710:2002, modified)

Installations électriques à basse tension - Errichten von Niederspannungsanlagen -
Partie 7-710: Règles pour les installations Teil 7-710: Anforderungen für
ou emplacements spéciaux - Betriebsstätten, Räume und Anlagen
Locaux à usages médicaux besonderer Art -
(CEI 60364-7-710:2002, modifiée) Medizinisch genutzte Bereiche
(IEC 60364-7-710:2002, modifiziert)

This Harmonization Document was approved by CENELEC on 2012-01-09. 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2012 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. HD 60364-7-710:2012 E

Foreword
This document (HD 60364-7-710:2012) consists of the text of IEC 60364-7-710:2002 prepared by IEC/TC 64
"Electrical installations and protection against electric shock", together with the common modifications
prepared by CLC/TC 64, "Electrical installations and protection against electric shock".
The following dates are fixed:
• latest date by which the document has to be
(dop) 2013-01-09
implemented at national level
by publication of an identical
national standard or by endorsement
• latest date by which the national standards conflicting
(dow) 2015-01-09
with the document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60364-7-710:2002 was approved by CENELEC as a European
Standard with common modifications.

- 3 - HD 60364-7-710:2012
Introduction
The requirements of this part of HD 60364 supplement, modify or replace certain of the general requirements
as contained in Parts 1 to 6 of HD 60364.
The clause numbering following 710 are those of the corresponding parts or clauses from Parts 1 to 6 of
HD 60364. The absence of reference to a part or a clause means that Parts 1 to 6 of HD 60364 are
applicable.
In medical locations it is necessary to ensure the safety of patients likely to be subjected to the application of
ME (medical electrical) equipment. For every activity and function in a medical location, the particular
requirements for safety have to be considered. Safety can be achieved by ensuring the safety of the
installation and the safe operation and maintenance of ME equipment connected to it. The use of ME
equipment on patients undergoing critical care has called for enhanced reliability and safety of electrical
installations in hospitals so as to improve the safety and continuity of supplies which is met by application of
this Harmonization Document. Variations of this document to further enhance safety and reliability are
acceptable.
710 Medical locations
710.1 Scope
The particular requirements of this part of HD 60364 apply to electrical installations in medical locations so
as to ensure safety of patients and medical staff. These requirements, in the main, refer to hospitals, private
clinics, medical and dental practices, health care centres and dedicated medical rooms in the work place.
The requirements of this part do not apply to ME equipment.
This part also applies to electrical installations in locations designed for medical research.
NOTE 1 It may be necessary to modify the existing electrical installation, in accordance with this standard, when a
change of utilization of the location occurs. Special care should be taken where intracardiac procedures are performed in
existing installations.
NOTE 2 Where applicable, this standard can also be used in veterinary clinics.
NOTE 3 For ME equipment and ME systems, refer to the EN 60601 series.
NOTE 4 Care should be taken that other installations should not impair the installations.
NOTE 5 These requirements concern, for example, electrical installations for medical locations in:
− hospitals and clinics (including container design);
− sanatoriums and health clinics;
− dedicated locations in homes for senior citizens and aged care, where the patients are subjected to medical care;
− medical centres, outpatients’ clinics and departments, casualty wards;
− other outpatients’ institutions (industrial, sports and others).
NOTE 6 The application of this Harmonization Document does not exempt to respect the national regulations.
710.2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
EN 61439 (all parts), Low-voltage switchgear and controlgear assemblies (IEC 61439 series)
EN 60601 (all parts), Medical electrical equipment (IEC 60601 series)
EN 60601-1:2006, Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005)
EN 61557-8:2007, 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 61557-8:2007 + corr. May 2007)
EN 61557-9:2009, 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 61557-9:2009)

- 5 - HD 60364-7-710:2012
EN 61558-2-15:2001 + Corrigendum 2004, Safety of power transformers, power supply units and similar –
Part 2-15: Particular requirements for isolating transformers for the supply of medical locations
(IEC 61558-2-15:1999, mod.)
HD 60364-4-41:2007, Low-voltage electrical installations – Part 4-41: Protection for safety – Protection
against electric shock (IEC 60364-4-41:2005, mod.)
HD 60364-6:2007, Low voltage electrical installations – Part 6: Verification (IEC 60364-6:2006, mod.)
IEC 60364-5-53: 2001, Electrical installations of buildings – Part 5-53: Selection and erection of electrical
equipment – Isolation, switching and control
IEC 60364-5-55:2001, Electrical installations of buildings – Part 5-55: Selection and erection of electrical
equipment – Other equipment
710.3 Definitions
For the purposes of this document, the following terms and definitions apply.
710.3.1
medical location
location intended for purposes of diagnosis, treatment (including cosmetic treatment), monitoring and care of
patients
710.3.2
patient
living being (person or animal) undergoing a medical, surgical or dental procedure
[SOURCE: EN 60601-1:2006, 3.76]
Note 1 to entry: The person under treatment for cosmetic purposes may be considered, as far as this standard is
concerned, as a patient.
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: EN 60601-1:2006, 3.63]

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: EN 60601-1:2006, 3.8]
710.3.5
group 0
medical location where no applied parts are intended to be used and where discontinuity (failure) of the
supply cannot cause danger to life
710.3.6
group 1
medical location where discontinuity of the electrical supply does not represent a threat to the safety of the
patient and where applied parts are intended to be used as follows:
− externally;
− invasively to any part of the body in locations outside of group 2 locations
710.3.7
group 2
medical location where applied parts are intended to be used in applications such as:
− intracardiac procedures; or
− vital treatments or surgical operations where discontinuity (failure) of the supply can cause danger to
patients
Note 1 to entry: An intracardiac procedure is a procedure whereby an electrical conductor is placed within the heart of
a patient or is likely to come into contact with the heart, such conductor being accessible outside the patient’s body. In
this context, an electrical conductor includes insulated wires such as cardiac pacing electrodes or intracardiac ECG
electrodes, or insulated tubes filled with conducting fluids.
710.3.8
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: EN 60601-1:2006, 3.64]
Note 1 to entry: The system includes those accessories which are needed for operating the system and are specified
by the manufacturer.
710.3.9
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
[SOURCE: EN 60601-1:2006, 3.79]

Note 1 to entry: For illustration see Figure 710A.
Note 2 to entry: This applies when the patients position is pre-determined, if not, all possible patient positions should
be considered.
- 7 - HD 60364-7-710:2012
710.3.10
medical IT system
IT electrical system fulfilling specific requirements for medical applications
Note 1 to entry: These supplies are also known as medical isolated power supply systems.
710.3.11
main distribution board
distribution board in the building which fulfils all the functions of a main electrical distribution for the supplied
building area assigned to it and where the voltage drop is measured for operating the main safety service
710.30 Assessment of general characteristics
Add:
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.
NOTE 1 Classification of a medical location should be related to the type of contact between applied parts and the
patient, the threat to the safety of the patient that represents a discontinuity (failure) of the electrical supply, as well as
the purpose for which the location is used (Guidance on the allocation of a group number and classification of safety
services for medical locations is shown in Annex B).
NOTE 2 To ensure protection of patients from possible electrical hazards, additional protective measures need to be
applied in medical locations. The type and description of these hazards can vary according to the treatment being
administered. The purpose for which a location is to be used may justify areas with different classifications (group 0, 1 or
2) for different medical procedures.
NOTE 3 Applied parts are defined by the particular standards for ME equipment.
NOTE 4 The possibility that certain medical locations could be used for different purposes which necessitate a higher
group should be addressed by risk management.
710.31 Purposes, supplies and structure
710.312.2 Types of system earthing
Add:
The TN-C system is not allowed in medical locations and medical buildings downstream of the main
distribution board.
710.313 Power supply
710.313.101 General
In medical locations the distribution system should be designed and installed to facilitate the automatic
change-over from the main distribution network to the electrical safety source feeding essential loads
(according to HD 60364-5-56:2010).

710.41 Protection for safety – Protection against electric shock
710.410.3 General requirements
710.410.3.5
The protective provisions "obstacles" and "placing out of reach" as specified in HD 60364-4-41:2007,
Annex B, shall not be applied.
710.410.3.6
The protective provisions "non-conducting location", "earth-free local equipotential bonding" and "electrical
separation for the supply of more than one item of current-using equipment" as specified in HD 60364-4-
41:2007, Annex C, shall not be applied.
710.411 Protective measure: automatic disconnection of supply
710.411.3 Requirements for fault protection (protection against indirect contact)
710.411.3.2 Automatic disconnection in case of a fault
710.411.3.2.1
Add:
Care shall be taken to ensure that simultaneous use of many items of equipment connected to the same
circuit cannot cause unwanted tripping of the residual current protective device (RCD).
In medical locations of group 1 and group 2, where RCDs are required, only type A or type B shall be
selected, depending on the possible fault-current arising.
710.411.3.2.5
Add:
In medical locations of group 1 and group 2, the following shall apply:
− for IT, TN and TT systems, the conventional touch voltage U shall not exceed 25 V a.c. (U ≤ 25 V a.c.)
L L
or 60 V d.c. (U ≤ 60 V d.c.)
L
NOTE In the TN system 25 V a.c. (U ≤ 25 V a.c.) or 60 V d.c. (U ≤ 60 V d.c.) can be met with an additional
L L
equipotential bonding, by complying with the disconnection time in accordance with the general standard.
710.411.3.3
Where a medical IT system is used for protective measure 411.3.3 is not applicable.
710.411.4 TN system
Add:
In final circuits of group 1 rated up to 32 A residual current protective devices with a rated residual operating
current not exceeding 30 mA shall be used.
In medical locations of group 2 (except for the medical IT system) protection by automatic disconnection of
supply by means of residual current protective devices with a rated residual-operating current not exceeding
30 mA shall only be used on the following circuits:
− circuits for the supply of movements of fixed operating tables;

- 9 - HD 60364-7-710:2012
NOTE 1 If the power consumption is less than 1 kVA, it could be connected to an ME IT system for touch voltage
reasons. Higher power consumption is acceptable, if the maximum touch voltage in the case of a first insulation fault will
be less than 10 mV.
− circuits for X-ray units;
NOTE 2 The requirement is mainly applicable to mobile X-ray units brought into group 2 locations.
− circuits for large equipment with a rated power greater than 5 kVA;
It is recommended that TN-S systems are monitored to ensure the insulation level of all live conductors
NOTE 3 A reduced insulation level of all live conductors should be reported to technical staff.
710.411.5 TT system
Add:
In medical locations of group 1 and group 2 residual current protective devices shall be used as
disconnection devices and the requirements of TN systems (see 710.411.4) apply.
710.411.6 IT system
710.411.6.3.101 Medical IT system
Add:
In group 2 medical locations, the medical IT system shall be used for final circuits supplying
ME equipment and ME systems intended for life support, surgical applications and other electrical equipment
located in the “patient environment” or that may be moved into the "patient environment", excluding
equipment listed in 710.411.4.
For each group of rooms serving the same function, at least one separate medical IT system is necessary.
The medical IT system shall be equipped with an insulation monitoring device (IMD) in accordance with
Annex A and Annex B of EN 61557-8:2007.
For each medical IT system, an acoustic and visual alarm system incorporating the following components
shall be arranged at a suitable place so that it can be permanently monitored (audible and visual signals) by
the medical staff and the technical staff:
− a green signal lamp to indicate normal operation;
− a yellow signal lamp which lights when the minimum value set for the insulation resistance is reached. It
shall not be possible for this light to be cancelled or disconnected;
− an audible alarm which sounds when the minimum value set for the insulation resistance is reached.
This audible alarm may be silenced;
− the yellow signal shall go out on removal of the fault and when the normal condition is restored.
NOTE 1  A written explanation should be easily readable in the medical location and it should include: the meaning of
each type of signalisation, alarm and the procedures to be followed in case of a first fault.
Monitoring of overload and high temperature for transformers for medical IT systems is required.
NOTE 2 When the IMD is designed for monitoring overload and temperature, it should be in accordance with Annex B of
EN 61557-8:2007.
The equipment for insulation fault location which localizes insulation faults in any part of the medical IT
system may also be installed in addition to an insulation monitoring device.
The insulation fault location equipment shall be in accordance with EN 61557-9.
710.411.7 Functional extra-low voltage (FELV)
In medical locations functional extra-low voltage (FELV) is not permitted.
710.414 Protective measures: extra-low-voltage provided by SELV and PELV
710.414.1 General
Add:
When using SELV and/or PELV circuits in medical locations of group 1 and group 2, the nominal voltage
applied to current-using equipment shall not exceed 25 V r.m.s. a.c. or 60 V ripple free d.c. Protection by
basic insulation of live parts according to HD 60364-4-41:2007, Clause A.1 or by barriers or enclosures
according to HD 60364-4-41:2007, Clause A.2 shall be provided.
710.414.4.1
Add:
In medical locations of group 2, where PELV is used, exposed-conductive-parts of equipment (e.g. operating
theatre luminaries) shall be connected to the protective bonding conductor.
710.415.2 Additional protection: supplementary protective equipotential bonding
710.415.2.1
Add:
In each medical location of group 1 and group 2, supplementary protective equipotential bonding 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, which are
located or which may be moved into the “patient environment”:
− protective conductors;
− extraneous-conductive-parts;
− screening against electrical interference fields, if installed;
− connection to conductive floor grids, if installed;
NOTE 1 If, due to floor grid connection to the supplementary equipotential bonding, an earth loop is formed, the
connection may be disregarded.
− metal screens of isolating transformers, via the shortest way to protective earthing conductor.
A sufficient number of supplementary equipotential bonding connection points for the connection of ME
equipment shall be available in group 2 and are recommended in group 1 (see also 710.30).
NOTE 2 Fixed conductive non-electrical patient supports such as operating theatre tables, physiotherapy couches and
dental chairs should be connected to the equipotential bonding conductor unless they are intended to be isolated from
earth.
- 11 - HD 60364-7-710:2012
710.415.2.2
Add:
In medical locations of group 1 the resistance of the protective conductors, including the resistance of the
connections, between the terminals for the protective conductor of socket-outlets and of fixed equipment or
any extraneous-conductive-parts and the equipotential bonding bus bar, shall not exceed 0,7 Ω.
NOTE 1 National regulations ensuring equivalent safety may apply.
In medical locations of group 2, the resistance of the protective conductors, including the resistance of the
connections, between the terminals for the protective conductor of socket-outlets and of fixed equipment or
any extraneous-conductive-parts and the equipotential bonding bus bar shall not exceed 0,2 Ω.
NOTE 2 National regulations ensuring equivalent safety may apply.
Add:
710.415.2.101
The equipotential bonding shall be located in or near the medical location and it shall be connected to the
main protective earth conductor with a conductor having a cross sectional area equivalent to the larger cross
sectional area of the conductors connected with the equipotential bonding. Connections shall be so arranged
that they are accessible, labelled, clearly visible and that they can easily be disconnected individually.
NOTE 1 It is recommended to use star-shaped or tree-shaped wiring and to avoid “earth-loops”.
NOTE 2 For rooms used for intracardiac procedures special national requirements to isolate the equipotential bonding
bus bar may apply.
710.42 Protection for safety – Protection against thermal effects
710.422 Precautions where particular risks of fire exist
Add:
National legislation providing additional requirements may exist.
710.44 Protection for safety – Protection against voltage disturbances and electromagnetic
disturbances
710.444 Measures against electromagnetic disturbances
Add:
Special considerations shall be made concerning electromagnetic interference and electromagnetic
compatibility. Further information is provided in Annex C.
710.51 Selection and erection of electrical equipment – Common rules
710.510.101 Distribution boards
Distribution boards shall be in accordance with EN 61439 series.
Distribution boards for group 2 shall be installed in close proximity to the group 2 medical locations and shall
be clearly identifiable.
NOTE 1 Dedicated distribution boards should be provided for the general power supply and the safety power system.

NOTE 2 Distribution boards should preferably be installed outside medical locations and should be safely guarded
against unauthorized persons.
NOTE 3 A distribution board for medical location is a board which fulfils all the functions for the supplied medical
location area assigned to it and where the voltage is monitored for operating the safety power system.
710.510.102 Electrical operating areas
Where electrical operating areas are arranged, national regulations prevail. If no national regulations are
available the following arrangements, if any, shall each be accommodated in their own enclosed electrical
operating areas:
− main transformer;
− switching stations with nominal voltages above 1 kV;
− main distributor for the general power supply;
− main distributor for the safety power supply;
− stationary generating set for the safety power supply;
− central batteries for the safety power supply, if the type of construction requires accommodation in an
enclosed electrical operating area, as well as converter and control cabinets for the additional safety
power supply.
See also 710.422.
710.512 Operational conditions and external influences
710.512.1 Operational conditions
710.512.1.101 Transformers for medical IT systems
Transformers shall be in accordance with EN 61558-2-15 with the following additional requirements.
The transformer shall be installed in close proximity to the medical location.
NOTE 1  A maximum distance for example of 25 m between the output terminals of the transformer and current using
equipment is strongly recommended.
The leakage current of the output winding to earth and the leakage current of the enclosure, when measured
in no-load condition and the transformer supplied at rated voltage and rated frequency, shall not exceed
0,5 mA.
At least one single-phase transformer per medical location or functional group of medical locations shall be
used to form the medical IT systems for portable and fixed equipment. The rated output shall not be less
than 0,5 kVA and shall not exceed 10 kVA. Where several transformers are needed to supply equipment in
one medical location, they shall not be connected in parallel.
NOTE 2  However, if national requirements allow a three-phase transformer to be applied for the supply of single-
phase loads, the construction or the method of connection should be such, that no voltage increase can occur on the
load side, not even in case of unbalanced load and other possible faults on the primary side. Under these conditions
three-phase transformers with secondary windings in either star or delta are acceptable.
If the supply of three-phase loads via an IT system is also required, a separate three-phase transformer shall
be provided for this purpose.
For monitoring see 710.411.6.3.101.

- 13 - HD 60364-7-710:2012
No capacitors shall be used in transformers for medical IT systems.
NOTE 3  National specifications may apply, e.g. distinction between supply of final circuits for several socket-outlets
and supply of final circuits for a single item of equipment.
710.512.1.102 Power supply for medical locations of group 2
In case of a single fault of supply, a total loss of power in a group 2 medical location shall be prevented.
NOTE Regardless of the implementation of a medical IT system and management of the total selectivity of the
protection devices, this may be achieved by either
− provision of two independent supply lines (see also 710.536.101), or
− provision of a ring-structure, capable to backup the mains supply, or
− a local additional power supply unit, or
− an additional power supply unit for several rooms of group 2, or
− other equally effective technical measures to ensure the continuity of mains power.
710.512.2 External influences
NOTE Where appropriate, attention should be given to the prevention of electromagnetic interference (see Annex C).
710.512.2.1 Explosion risk
National legislation providing additional requirements may exist.
NOTE 1 Requirements for ME equipment for use in conjunction with flammable gases and vapours are contained in
EN 60601-1:2006.
NOTE 2 Where hazardous conditions are likely to occur (for example in the presence of flammable gases and
vapours), special precautions may be required.
NOTE 3 Prevention of build-up of static electricity is recommended.
Electrical devices (socket-outlets and switches) installed below any medical gas outlets for oxidizing or
flammable gases shall be located at a distance of at least 0,2 m from the outlet (centre to centre), so as to
minimize the risk of ignition of flammable gases.
NOTE 4 For medical supply units see EN ISO 11197.
710.514 Identification
710.514.3 Identification of conductors
Add:
710.514.3.1.101 Identification of protective bonding conductors
Protective bonding conductors for supplementary bonding shall be marked green-yellow at least at the points
of connection.
710.514.5 Diagrams and documentation
710.514.5.1
Add:
Plans of the electrical installation together with records, drawings, wiring diagrams and modifications thereto,
shall be provided for the user.
The relevant documents are in particular:
− single-line overview diagram showing the distribution system of the normal power supply and power
supply for safety services in a single-line representation. These diagrams shall contain information on
the location of the sub-distribution boards within the building;
− main and sub-distribution board block diagrams showing switchgear and controlgear and distribution
boards in a single-line representation;
− building drawings;
− schematic diagrams of controls;
− verification of compliance with the requirements of standards (e.g. with 710.411);
− list of loads permanently connected to the power supply for safety services indicating the normal
currents and, in the case of motor-operated loads, the starting currents;
− functional description for the operation of the safety power supply services and of the safety power
supply system.
NOTE Examples of mathematical verifications are
− coordination of automatic disconnection by the protective devices directly connected to the supply side at short-circuit
conditions;
− computation and verification especially important for electronic current-sources (power inverter).
Add:
710.514.101 Operating instructions
Instructions for operation and maintenance shall be provided for the user.
The relevant documents are in particular
− instructions for operation, inspection, testing and maintenance of storage batteries and power sources
for safety services,
− a logbook containing a record of all tests and visual inspections which require to be completed prior to
commissioning,
− information regarding visual inspection(s).
710.52 Selection and erection of electrical equipment – Wiring systems
Add:
Any wiring system within group 2 medical locations shall be exclusive to the use of equipment and
accessories in that location.
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710.53 Selection and erection of electrical equipment – Switchgear and controlgear
710.531.1 Overcurrent protective devices
710.531.1.101 Protection of wiring systems in medical locations of group 2
Add:
Overload current protection is not allowed in secondary circuit of the transformer of a medical IT system.
NOTE  Overcurrent protective devices (fuses) may be used in the incoming line of the transformer for short-circuit
protection only.
Overcurrent protection against short-circuit and overload current is necessary for each final circuit.
710.531.3 Insulation monitoring devices (IMD)
IMD shall be installed and connected as close as possible to the origin of the medical IT system.
710.535 Coordination of various protective devices
710.535.1 Discrimination of different overcurrent protective devices
Selectivity shall be ensured: In case of a short-circuit in a final circuit the incoming circuits of the upstream
distribution board shall not be interrupted.
710.536 Devices for isolation and switching
710.536.101 Automatic change-over devices
Automatic change-over devices shall be arranged so that safe separation between supply-lines is
maintained.
NOTE 1 This can be achieved for example by ensuring that the maximum total operating time (from the first fault to
extinguishing the electric arc of the switching device) is less than the minimum time-delayed switch-over time of the
automatic switching system.
In this case, cables between the automatic switching system and the subsequent over-current protection
device should be installed short-circuit and earth-fault proof.
NOTE 2 Automatic change-over devices should comply with EN 60947-6-1.
710.55 Selection and erection of electrical equipment – Other equipment
710.55.101 Socket-outlets protected by residual current protective devices (RCDs)
For each circuit protected by a RCD with a rated residual operating current not exceeding 30 mA,
considerations shall be given to the maximum number of socket-outlets protected by the RCD.
710.55.102 Socket-outlet circuits in the medical IT system for medical locations of group 2
Socket-outlets, intended to supply ME equipment shall be fitted with a supply indicator.
NOTE 1 For supply indicator luminaries the emission of green light is preferred.
At each patient’s place of treatment, for example bedheads, the configuration of socket-outlets shall be as
follows:
− each socket-outlet supplied by an individually protected circuit; or

− several socket outlets separately supplied by a minimum of two circuits.
NOTE 2 Each circuit should preferably supply socket-outlets assigned to one place of treatment only.
Where circuits are supplied from other systems (TN-S or TT-Systems) in the same medical location, the
socket-outlets of medical IT systems shall not be switchable and shall either:
− of such construction, prevents their use in other systems; or
− clearly and permanently marked.
710.559 Luminaires and lighting installations
710.559.101 Lighting circuits
In medical locations of group 1 and group 2 at least two different sources of supply shall be provided. One of
the two sources shall be connected to the electric supply system for safety services.
In escape routes, alternate luminaries shall be connected to the safety service (see 710.56).
NOTE Minimum level of illumination (under consideration).
710.56 Selection and erection of electrical equipment – Safety services
Add:
In medical locations a power supply for safety services is required, which, in accordance with the standard,
will energize the installations needed for continuous operation in case of failure of the general power system,
for a defined period within a pre-set switch-over time.
NOTE 1  The responsible management of the medical location (including medical staff) should be involved in the
decision where safety services are needed.
The safety power supply system shall automatically take over, if the voltage of one or more incoming live
conductors of the main distribution board of the building with the main power supply drops to less than 90 %
of the nominal voltage and during more than 0,5 s.
NOTE 2  Electric sources for safety services and the electrical supply system for safety services should be arranged in
such a way that periodic verification and necessary maintenance can be performed without neither reducing the
availability of the electric power supply for the safety services nor impairing the electric power supply for the safety
services.
710.560.4 Classification
710.560.4.1 Classification of safety services
Replace by:
Classification of safety services are given in Annex A.
710.560.6  Electrical sources for safety services
710.560.6.101
In case of a failure of the general power supply source, the power supply for safety services shall be
energized to feed the equipment stated in 710.560.6.104.1, 710.560.6.104.2 and 710.560.6.104.3 with
electrical energy for a defined period of time and within a pre-determined change-over period.

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710.560.6.102
For interconnecting cables between the individual components and subassemblies of safety power supply
sources, see 710.52.
NOTE  The circuit which connects the power supply source for safety services to the main distribution board should be
considered a safety circuit.
710.560.6.103
Where socket-outlets are supplied from the safety power supply source they shall be readily identifiable.
Socket-outlets supplied from a safety power supply source shall also be readily identifiable according to their
safety services classification.
710.560.6.104 Detailed requirements for safety power supply services
710.560.6.104.1 Power supply sources with a change-over period less than or equal to 0,5 s
In the event of a voltage failure on one or more line conductors at the distribution board, a safety power
supply shall be used which is capable of providing power supply for a period of at least 3 h for:
− luminaries of operating theatre tables;
− ME equipment containing light sources being essential for the application of the equipment,
endoscopes, including associated essential equipment, e.g. monitors;
− critical life-supporting ME equipment.
The power supply shall be restored within a change-over period not exceeding 0,5 s.
NOTE 1 The duration of 3 h may be reduced to 1 h if a power source according to 710.560.6.104.2 is installed.
NOTE 2 Included under other indispensable luminaries may be light sources for endoscopic surgical field-luminaries.
710.560.6.104.2 Power supply sources with a change-over period less than or equal to 15 s
Equipment according to 710.560.9 shall be connected within 15 s to a safety power supply source capable of
maintaining it for a minimum period of 24 h, when the voltage of one or more live conductors at the main
distribution board for the safety services drops to less than 90 % of the nominal voltage and during more
than 3 s.
NOTE The duration of 24 h may be reduced to a minimum of three hours, if the medical requirements and the use of
the location, including any treatment allows this and if the building can be evacuated in a time which is well within the
three-hour-period.
710.560.6.104.3 Power supply sources with a changeover period greater than 15 s
Equipment other than those covered by 710.560.6.104.1 and 710.560.6.104.2, which is required for the
maintenance of hospital services, may be connected either automatically or manually to a safety power
supply source capable of maintaining it for a minimum period of 24 h.
710.560.6.1.101 General requirements for safety power supply sources of group 1 and group 2
Primary cells are not allowed as safety power sources.
An additional main incoming power supply from the general power supply is not regarded as a source of the
safety power supply.
NOTE If unit-type power stations with jacking-piston combustion engines are used as safety power sources see
ISO 8528-1:2005. For calculations of supplied power only prime power (PRP) specifications according to
ISO 8528-1:2005 should be used (see ISO 8528-1:2005, 13.3.2).

The availability (readiness for service) of safety power sources shall be monitored and indicated at a suitable
location.
710.560.9 Emergency escape lighting applications
Add:
In the event of mains power failure, the changeover period to the safety services source shall not exceed
15 s. The necessary minimum illuminance shall be provided for the following locations:
− locations for switchgear and controlgear for emergency generation sets and for main distribution boards
of the normal power supply and for power supply for safety services;
− locations intended for essential services. In each such location at least one luminaire shall be supplied
from the power source for safety services;
− locations of central fire alarm and monitoring systems;
− rooms of group 1 medical locations. In each such room at least one luminaire shall be supplied from the
power supply source for safety services;
NOTE In group 1 medical locations outside hospitals or equivalent institutions it may not be necessary to install any
safety power supply at all, if a failure of the supply causes no danger to finish the procedures and evacuate the location.
− rooms of group 2 medical locations. A minimum of 50 % of the lighting shall be supplied from the power
source for safety services.
If discriminate protection by disconnection of supply is applicable, it shall be so arranged that the protective
equipment does not disconnect all of the lighting circuits of the room or escape route.
710.6 Verification
710.61 Initial verification
Add:
Initial verification shall be carried out in accordance with local/national regulations. If no local/national
regulations exist, the following tests are recommended.
The tests specified under items a) to g) and in addition to the requirements of HD 60364-6, shall be carried
out, both prior to commissioning and after alterations or repairs and before re-commissioning:
a) functional test of insulating monitoring devices and overload monitoring system of medical IT systems
and acoustical/visual alarm systems;
b) measurements to verify that the supplementary equipotential bonding is in accordance with 710.415.2.1
and 710.415.2.2;
c) verification of the integrity of the facilities for equipotential bonding required by 710.415.2;
d) verification of the integrity of the requirements for safety services of 710.56;
e) measurements of leakage current of the output circuit and of the enclosure of medical IT transformers in
no-load condition;
f) mathematical verification of the compliance of the selectivity of the safety power supply in regard to
planning documents and calculation;

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g) mathematical verification of the applied protective measures for compliance with the requirements for
group 1 and group 2 with attention to the requirements of 710.535.1.
710.62 Periodic verification
Add:
The contractor or the manufacturer shall give advice to the operating authority in the operating instructions
for the following necessary periodic verification.
Procedures for the periodic verification shall be made in close cooperation with the medical staff in order to
keep the risk for patients to a minimum.
Periodic verification of items a) to g) of 710.61 shall be carried out in accordance with local/
...

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