HD 60364-7-710:2012

SLOVENSKI STANDARD
01-maj-2012
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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.

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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)

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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.
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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 hig
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