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All rights reserved to GCC Standardization Organization (GSO). Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either GSO at the address below or GSO's member body in the country of the requester.

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P.O.Box: 85245 Riyadh 12511

Kingdom of Saudi Arabia

إدارة التواصل، قسم إدارة المعرفة

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Website:

www.gso.org.sa

:موقع ويب

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GSO IEC 60364-7-710:2015Gulf Standard

Gulf Foreword

GCC Standardization Organization (GSO) is a regional organization which consists of the national standardization bodies of GCC member states. One of GSO main functions is to issue gulf standards and technical regulations through specialized technical committees.

GSO Technical Council in its meeting number (36) held on 19/11/1436 H, which corresponds to 03/09/2015, has approved Gulf Standard GSO IEC 60364-7-710:2015 titled "Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations" in English language which was studied and adopted by endorsement from International Electrotechnical Commission Standard IEC 60364-7-710:2002 through fast track .

تقديم خليجي

هيئة التقييس لدول مجلس التعاون لدول الخليج العربية هيئة إقليمية تضم في عضويتها أجهزة التقييس الوطنية في الدول الأعضاء ، ومن مهام الهيئة إعداد المواصفات القياسية واللوائح الفنية الخليجية بواسطة لجان فنية متخصصة.

قرر المجلس الفني لهيئة التقييس لدول مجلس التعاون لدول الخليج العربية في الاجتماع الـ (36) بتاريخ 1436/11/19 هـ ،الموافق 2015/09/03م اعتماد المواصفة القياسية الخليجية رقم GSO IEC 60364-7-710:2015 وعنوانها "التركيبات الكهربائية للمباني - الجزء 7- 710: متطلبات التركيبات أو المواقع الخاصة- المواقع الطبية" باللغة الانجليزية التي تم دراستها وتبنيها بالمصادقة عبر المسار السريع عن اللجنة الدولية الكهروتقنية رقم IEC 60364-7-710:2002 .

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IEC 60364-7-710:2002 ED1 © IEC 2002

Gulf StandardGSO IEC 60364-7-710:2015

GSO IEC 60364-7-710:2015Gulf Standard

IEC 60364-7-710

	INTERNATIONAL STANDARD	Edition 1.0 2002-11


	Electrical installations of buildings – Part 7-710: Requirements for special installations or locations – Medical locations

IEC 60364-7-710:2002 ED1

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Gulf StandardGSO IEC 60364-7-710:2015

GSO IEC 60364-7-710:2015Gulf Standard

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IEC 60364-7-710:2002 ED1 © IEC 2002

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IEC 60364-7-710:2002 ED1 © IEC 2002

Gulf StandardGSO IEC 60364-7-710:2015

GSO IEC 60364-7-710:2015Gulf Standard

IEC 60364-7-710

	INTERNATIONAL STANDARD	Edition 1.0 2002-11


	Electrical installations of buildings – Part 7-710: Requirements for special installations or locations – Medical locations

INTERNATIONAL

ELECTROTECHNCIAL

COMMISSION

ICS 29.020, 91.140.50ISBN 2831867185Warning! Make sure that you obtained this publication from an authorized distributor.© Registered trademark of the International Electrotechnical Commission

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GSO IEC 60364-7-710:2015Gulf Standard

CONTENTS

FOREWORD

INTRODUCTION

710 Medical locations

710.1 Scope

710.2 Normative references

710.3 Definitions

710.30 Assessment of general characteristics

710.31 Purposes, supplies and structure

710.312.2 Types of system earthing

710.313 Power supply

710.313.1 General

710.4 Protection for safety

710.41 Protection against electric shock

710.411 Protection against both direct and indirect contact

710.411.1 SELV and PELV

710.412 Protection against direct contact

710.412.3 Obstacles

710.412.4 Placing out of reach

710.413 Protection against indirect contact

710.413.1 Automatic disconnection of supply

710.422 Fire protection

710.5 Selection and erection of electrical equipment

710.51 Common rules

710.512 Operational conditions and external influences

710.512.1 Operating conditions

710.512.1.1 Transformers for medical IT systems

710.512.1.6 Medical IT systems for group 2 medical locations

710.512.2 External influences

710.512.2.1 Explosion risk

710.514.5 Diagrams, documentation and operating instructions

710.52 Wiring systems

710.53 Switchgear and controlgear

710.53.1 Protection of wiring systems in medical locations of group 2

710.55 Other equipment

710.55.1 Lighting circuits

710.55.3 Socket-outlet circuits in the medical IT system for medical locations of group 2

710.556 Safety services

710.556.5.2 Sources

710.556.7 Safety lighting circuits

710.556.8 Other services

710.6 Verification

710.61 Initial verification

710.62 Periodic verification

Annex A Classification of safety services for medical locations

Annex B Examples for allocation of group numbers and classification for safety services of medical locations

Bibliography

INTERNATIONAL ELECTROTECHNICAL COMMISSION

International StandardIEC 60364-7-710:2002 ED1

Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations

FOREWORD

The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.

The formal decisions or agreements of the 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 National Committees.

The documents produced have the form of recommendations for international use and are published in the form of standards, technical specifications, technical reports or guides and they are accepted by the National Committees in that sense.

In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter.

The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards.

Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 60364‑7‑710 has been prepared by IEC technical committee 64: Electrical installations and protection against electric shock.

The text of this standard is based on the following documents:

FDIS	Report on voting
64/1268/FDIS	64/1275/RVD

Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

The committee has decided that the contents of this publication will remain unchanged until 2007. At this date, the publication will be

•

reconfirmed;

•

withdrawn;

•

replaced by a revised edition, or

•

amended.

INTRODUCTION

The requirements of this part of IEC 60364 supplement, modify or replace certain of the general requirements as contained in parts 1 to 6 of IEC 60364.

The clause numbering following 710 are those of the corresponding parts or clauses from parts 1 to 6 of IEC 60364.

The absence of reference to a part or a clause means that parts 1 to 6 of IEC 60364 are applicable.

In medical locations it is necessary to ensure the safety of patients likely to be subjected to the application of 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 medical electrical equipment connected to it. The use of medical electrical equipment on patients undergoing intensive care (of critical importance) 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 standard. Variations of the standard to further enhance safety and reliability are acceptable.

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GSO IEC 60364-7-710:2015Gulf Standard

International StandardIEC 60364-7-710:2002 ED1

Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations

710Medical locations

710.1Scope

The particular requirements of this part of IEC 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.

NOTE 1It 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 2Where applicable this standard can also be used in veterinary clinics. The requirements of this part do not apply to medical electrical equipment.

NOTE 3For medical electrical equipment, refer to the IEC 60601 series.

710.2Normative references

The following referenced documents are indispensable for the application 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 60364‑4‑41:2001, Electrical installations of buildings – Part 4-41: Protection for safety – Protection against electric shock

IEC 60364‑5‑55:2001, Electrical installations of buildings – Part 5-55: Selection and erection of electrical equipment – Other equipment

IEC 60364‑6‑61:2001, Electrical installations of buildings – Part 6-61: Verification – Initial verification

IEC 60601‑1:1988, Medical electrical equipment – Part 1: General requirements for safety

Amendment 2 (1995)

IEC 60601‑1‑1:2000, Medical electrical equipment – Part 1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems

IEC 60617‑1:1985, Graphical symbols for diagrams – Part 1: General information, general index – Cross-reference tables

IEC 60617‑11(DB), 1 Graphical symbols for diagrams – Part 11: Architectural and topographical installation plans and diagrams

IEC 61082‑1:1991, Preparation of documents used in electrotechnology – Part 1: General requirements

IEC 61557‑8:1997, 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 61558‑2‑15:1999, Safety of power transformers, power supply units and similar – Part 2-15: Particular requirements for isolating transformers for the supply of medical locations

710.3Definitions

For the purposes of this part of IEC 60364, the following definitions apply.

710.3.1

medical location

location intended for purposes of diagnosis, treatment (including cosmetic treatment), monitoring and care of patients

Note 1 to entry: 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 manner in which a room is to be used necessitates some division into different areas for differing medical procedures.

710.3.2

patient

living being (person or animal) undergoing medical or dental investigation or treatment
(adapted from 2.12.4 of IEC 60601‑1)

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

electrical equipment, provided with not more than one connection to a particular supply mains and intended to diagnose, treat or monitor the patient under medical supervision and which

–

makes physical or electrical contact with the patient, and/or

–

transfers energy to or from the patient, and/or

–

detects such energy transfer to or from the patient.

Note 1 to entry: The equipment includes those accessories defined by the manufacturer as being necessary to enable normal use of the equipment.

710.3.4

applied part

part of the medical electrical equipment which in normal use

–

necessarily comes into physical contact with the patient for the equipment to perform its function, or

–

can be brought into contact with the patient, or

–

needs to be touched by the patient

(adapted from 2.1.5 of amendment 2 to IEC 60601‑1)

710.3.5

group 0

medical location where no applied parts are intended to be used

710.3.6

group 1

medical location where applied parts are intended to be used as follows:

–

externally;

–

invasively to any part of the body, except where 710.3.7 applies

710.3.7

group 2

medical location where applied parts are intended to be used in applications such as intracardiac procedures, operating theatres and vital treatment where discontinuity (failure) of the supply can cause danger to life

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

combination of items of equipment, at least one of which is an item of medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet

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 patient and parts of the system or between patient and other persons touching parts of the system (for illustration see Figure 710A)

Note 1 to entry: This applies when the patient’s position is pre-determined, if not, all possible patient positions should be considered.

710.3.10

main distribution board

board in the building which fulfils all the functions of a main electrical distribution for the supply building area assigned to it and where the voltage drop is measured for operating the safety services

710.3.11

medical IT system

IT electrical system having specific requirements for medical applications

710.30Assessment of general characteristics

The classification of a medical location shall be made in agreement with the medical staff, health organization concerned or body responsible for the safety of workers in accordance with national regulations. 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 (the possibility that certain medical locations may be used for different purposes which necessitate a higher group should be addressed by risk management).

NOTE 1Classification of a medical location should be related to the type of contact between applied parts and the patient, as well as the purpose for which the location is used (see Annex B).

NOTE 2Applied parts are defined by the particular standards for medical electrical equipment.

710.31Purposes, supplies and structure

710.312.2Types of system earthing

The TN-C system is not allowed in medical locations and medical buildings downstream of the main distribution board.

710.313Power supply

710.313.1General

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 IEC 60364‑5‑55, clause 556).

710.4Protection for safety

710.41Protection against electric shock

710.411Protection against both direct and indirect contact

710.411.1SELV and PELV

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 insulation of live parts according to 412.1 of IEC 60364‑4‑41 and by barriers or enclosures according to 412.2 of the same standard is essential.

In medical locations of group 2, exposed-conductive-parts of equipment (e.g. operating theatre luminaires), shall be connected to the equipotential bonding conductor.

710.412Protection against direct contact

710.412.3Obstacles

Protection by obstacles is not permitted.

710.412.4Placing out of reach

Protection by placing out of reach is not permitted.

Only protection by insulation of live parts or protection by barriers or enclosures are permitted.

710.413Protection against indirect contact

710.413.1Automatic disconnection of supply

710.413.1.1General

710.413.1.1.1Disconnection of supply

In medical locations of group 1 and group 2, the following shall apply:

–

for IT, TN and TT systems, the conventional touch voltage UL shall not exceed 25 V (UL ≤ 25 V);

–

for TN and IT systems, table 41C of IEC 60364‑4‑41 shall apply.

NOTEDisconnection of supply when overload or short-circuit conditions occur, can be achieved by different design methods within the procedures of the general rules in order to satisfy the required safety level.

710.413.1.3TN systems

In final circuits of group 1 rated up to 32 A residual current devices with a maximum residual operating current of 30 mA shall be used (additional protection).

In medical locations of group 2, protection by automatic disconnection of supply by means of residual current protective devices with the rated residual-operating-current not exceeding 30 mA shall only be used on the following circuits:

–

circuits for the supply of operating tables;

–

circuits for X-ray units;

NOTEThe 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;

–

circuits for non-critical electrical equipment (non life support).

Care shall be taken to ensure that simultaneous use of many items of such 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 by this subclause, only type A or type B shall be selected, depending on the possible fault-current arising.

NOTEIt is recommended that TN-S systems are monitored to ensure the insulation level of all live conductors.

710.413.1.4TT systems

In medical locations of group 1 and group 2, the requirements of TN systems (see 710.413.1.3) apply and in all cases residual current protective devices shall be used.

710.413.1.5Medical IT system

NOTE 1In the United States such a system is identified as an “Isolated Power System”.

In group 2 medical locations, the medical IT system shall be used for circuits supplying medical electrical equipment and systems intended for life support, surgical applications and other electrical equipment located in the "patient environment", excluding equipment listed in 713.413.1.3.

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 in accordance with IEC 61557‑8 with the following specific requirements:

–

the a.c. internal impedance shall be at least 100 kΩ;

–

the test voltage shall not be greater than 25 V d.c.;

–

the injected current, even under fault conditions, shall not be greater than 1 mA peak;

–

indication shall take place at the latest when the insulation resistance has decreased to 50 kΩ. A test device shall be provided;

NOTE 2In Germany, an indication is required if the earth or wiring connection is lost.

NOTE 3The necessary additional requirements on IMDs given above are at this time not covered in the equipment standard IEC 61557‑8. They will be removed from this publication as soon as they have been treated in the relevant equipment standard.

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:

–

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.

Where only one equipment is supplied from one single dedicated IT transformer, the latter can be installed without an insulation monitoring device.

Monitoring of overload and high temperature for the medical IT transformer is required.

710.413.1.6Supplementary equipotential bonding

710.413.1.6.1In each medical location of group 1 and group 2, supplementary equipotential bonding conductors shall be installed and connected to the equipotential bonding bus bar for the purpose of equalizing potential differences between the following parts, located in the "patient environment":

–

protective conductors;

–

extraneous-conductive-parts;

–

screening against electrical interference fields, if installed;

–

connection to conductive floor grids, if installed;

–

metal screen of the isolating transformer, if any.

NOTEFixed 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.

710.413.1.6.2In medical locations of group 2, the resistance of the 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.

NOTEThis resistive value can also be determined by the use of a suitable cross-sectional area of the conductor.

710.413.1.6.3The equipotential bonding bus bar shall be located in or near the medical location. In each distribution board or in its proximity, an additional equipotential bonding bar shall be provided to which the supplementary equipotential bonding conductor and protective earth conductor shall be connected. Connections shall be so arranged that they are clearly visible and easily disconnected individually.

710.422Fire protection

National legislation providing additional requirements may exist.

710.5Selection and erection of electrical equipment

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Bibliography

IEC 60364‑4‑44:2001, Electrical installations of buildings – Part 4-44: Protection for safety – Protection against voltage disturbances and electromagnetic disturbances

IEC 60364‑5‑51:2001, Electrical installations of buildings – Part 5-51: Selection and erection of electrical equipment – Common rules

IEC 60364‑5‑52:2001, Electrical installations of buildings – Part 5-52: Selection and erection of electrical equipment – Wiring systems

IEC 60364‑5‑53:2001, Electrical installations of buildings – Part 5-53: Selection and erection of electrical equipment – Isolation, switching and control

IEC 60364‑5‑54:2002, Electrical installations of buildings – Part 5-54: Selection and erection of electrical equipment – Earthing arrangements, protective conductors and equipotential bonding

IEC 60617‑2(DB), Graphical symbols for diagrams

– Part 2: Symbol elements, qualifying symbols and other symbols having general application

– Part 3: Conductors and connecting devices

– Part 6: Production and conversion of electrical energy

– Part 7: Switchgear, controlgear and protective devices

– Part 8: Measuring instruments, lamps and signalling devices

IEC 60755:1983, General requirements for residual current operated protective devices

IEC 61008‑1:1996, Residual current operated circuit-breakers without integral overcurrent protection for household and similar uses (RCCBs) – Part 1: General rules

IEC 61009‑1:1996, Residual current operated circuit-breakers with integral overcurrent protection for household and similar uses (RCBOs) – Part 1: General rules

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