SIST HD 60364-7-710:2012

SLOVENSKI STANDARD
oSIST prHD 60364-7-710:2008
01-september-2008
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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 médicauxx
Ta slovenski standard je istoveten z: prHD 60364-7-710:2008
ICS:
29.020 Elektrotehnika na splošno Electrical engineering in
general
91.140.50 Sistemi za oskrbo z elektriko Electricity supply systems
oSIST prHD 60364-7-710:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prHD 60364-7-710:2008
 DRAFT
HARMONIZATION DOCUMENT
prHD 60364-7-710

DOCUMENT D'HARMONISATION
June 2008
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 spezielle
ou emplacements spéciaux - Installationen oder Standorte -
Locaux à usages médicaux Medizinische Standorte und zugehörige
(CEI 60364-7-710:2002, modifiée) Bereiche
(IEC 60364-7-710:2002, modifiziert)


This draft Harmonization Document is submitted to CENELEC members for CENELEC enquiry.
Deadline for CENELEC: 2008-10-17.

The text of this draft consists of the text of IEC 60364-7-710:2002 with common modifications prepared by
CLC/SC 64A.

If this draft becomes a Harmonization Document, CENELEC members are bound to comply with the
CEN/CENELEC Internal Regulations which stipulate the conditions for implementation of this Harmonization
Document on a national level.

This draft Harmonization Document was established by CENELEC in three official versions (English, French,
German).

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, 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 and the United Kingdom.

Warning : This document is not a Harmonization Document. It is distributed for review and comments. It is
subject to change without notice and shall not be referred to as a Harmonization Document.


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

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Project: 2282 Ref. No. prHD 60364-7-710:2008 E

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prHD 60364-7-710:2008 – 2 –
1 Foreword
2 The text of the International Standard IEC 60364-7-710:2002, prepared by IEC TC 64, Electrical
3 installations and protection against electric shock, together with the common modifications prepared
4 by WG 710 of SC 64A, Electrical installations and protection against electric shock – Protection
5 against electric shock, of Technical Committee CENELEC TC 64, Electrical installations and protection
6 against electric shock, is submitted to the CENELEC enquiry (4MP) for acceptance as a
7 Harmonization Document.
8 __________
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9 Text of prHD 60364-7-710
10 Introduction
11 The requirements of this part of HD 60364 supplement, modify or replace certain of the general
12 requirements as contained in Parts 1 to 6 of HD 60364.
13 The clause numbering following 710 are those of the corresponding parts or clauses from Parts 1 to 6
14 of HD 60364. The absence of reference to a part or a clause means that Parts 1 to 6 of HD 60364 are
15 applicable.
16 Clauses, subclauses, notes, tables and figures which are additional to those in IEC 60364-7-710:2002
17 are prefixed “Z”.
18 In medical locations it is necessary to ensure the safety of patients likely to be subjected to the
19 application of medical electrical equipment. For every activity and function in a medical location,
20 the particular requirements for safety have to be considered. Safety can be achieved by ensuring the
21 safety of the installation and the safe operation and maintenance of medical electrical equipment
22 connected to it. The use of medical electrical equipment on patients undergoing intensive care
23 (of critical importance) has called for enhanced reliability and safety of electrical installations in
24 hospitals so as to improve the safety and continuity of supplies which is met by application of this
25 Harmonization Document. Variations of this document to further enhance safety and reliability are
26 acceptable.
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27 710 Medical locations
28 710.1 Scope
29 The particular requirements of this part of HD 60364 apply to electrical installations in medical
30 locations so as to ensure safety of patients and medical staff. These requirements, in the main, refer
31 to hospitals, private clinics, medical and dental practices, health care centres and dedicated medical
32 rooms in the work place.
33 The requirements of this part do not apply to medical electrical equipment.
34 This part also applies to electrical installations in locations designed for medical research.
35 NOTE 1 It may be necessary to modify the existing electrical installation, in accordance with this standard, when a change of
36 utilization of the location occurs. Special care should be taken where intracardiac procedures are performed in existing
37 installations.
38 NOTE 2 Where applicable, this standard can also be used in veterinary clinics.
39 NOTE 3 For medical electrical equipment and medical electrical systems, refer to the EN 60601 series.
40 NOTE Z1 Care should be taken that other installations (e.g. data networks etc.) should not impair the installations. safety level.
41 NOTE Z2 These requirements concern, for example, electrical installations for medical locations in:
42 − hospitals and clinics (including container design);
43 − sanatoriums and health clinics;
44 − dedicated locations in homes for senior citizens and aged care, where the patients are subjected to medical care;
45 − medical centres, outpatients’ clinics and departments, casualty wards;
46 − other outpatients’ institutions (industrial, sports and others).
47 NOTE Z3 The application of this Harmonization Document does not exempt to respect the national rules.
48 710.2 Normative references
49 The following referenced documents are indispensable for the application of this document. For dated
50 references, only the edition cited applies. For undated references, the latest edition of the referenced
51 document (including any amendments) applies.
52 EN 60439 series, Low-voltage switchgear and controlgear assemblies (IEC 60439 series)
53 EN 60601 series, Medical electrical equipment (IEC 60601 series)
54 EN 60601-1:2006, Medical electrical equipment – Part 1: General requirements for basic safety and
55 essential performance (IEC 60601-1:2005)
56 EN 60601-1-1:2001, Medical electrical equipment – Part 1-1: General requirements for safety;
57 Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)
1)
58 EN 61557-8:1997 , Electrical safety in low voltage distribution systems up to 1 000 V a.c. and
59 1 500 V d.c. – Equipment for testing, measuring or monitoring of protective measures – Part 8:
60 Insulation monitoring devices for IT systems (IEC 61557-8:1997)
61 EN 61557-9, Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. -
62 Equipment for testing, measuring or monitoring of protective measures – Part 9 : Equipment for
63 insulation fault location in IT systems (IEC 61557-9)
———————
1) Will be superseded by 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 (based on IEC 61557-8:2007) on 2010-05-01.
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64 EN 61558-2-15:2001, Safety of power transformers, power supply units and similar – Part 2-15:
65 Particular requirements for isolating transformers for the supply of medical locations
66 (IEC 61558-2-15:1999, mod.)
2)
67 HD 384.6.61 S2:2003 , Electrical installations of buildings – Part 6-61: Verification – Initial verification
68 (IEC 60364-6-61:1986, mod. + A1:1993, mod. + A2:1997, mod.)
69 HD 60364 series, Low-voltage electrical installations (IEC 60364 series, mod.)
70 HD 60364-4-41:2007, Low-voltage electrical installation – Part 4-41: Protection for safety – Protection
71 against electric shock (IEC 60364-4-41:2005, mod.)
72 IEC 60364-5-53, Electrical installations of buildings – Part 5-53: Selection and erection of electrical
73 equipment – Isolation, switching and control
74 IEC 60364-5-55:2001, Electrical installations of buildings – Part 5-55: Selection and erection of
75 electrical equipment - Other equipment
76 IEC 60670-24, Boxes and enclosures for electrical accessories for household and similar fixed
77 electrical installations – Part 24: Particular requirements for enclosures for housing protective devices
78 and similar power consuming devices
79 ISO 8528-1:2005, Reciprocating internal combustion engine driven alternating current generating
80 sets – Part 1: Application, ratings and performance
81 710.3 Definitions
82 For the purposes of this document, the following terms and definitions apply.
83 710.3.1
84 medical location
85 location intended for purposes of diagnosis, treatment (including cosmetic treatment), monitoring and
86 care of patients
87 710.3.2
88 patient
89 living being (person or animal) undergoing a medical, surgical or dental procedure
90 [EN 60601-1:2006, definition 3.76]
91 NOTE The person under treatment for cosmetic purposes may be considered, as far as this standard is concerned, as a
92 patient.
93 710.3.3
94 medical electrical equipment (ME equipment)
95 electrical equipment having an applied part or transferring energy to or from the patient or detecting
96 such energy transfer to or from the patient and which is
97 a) provided with not more than one connection to a particular supply mains, and
98 b) intended by its manufacturer to be used
99 − in the diagnosis, treatment, or monitoring of a patient, or
100 − for compensation or alleviation of disease, injury or disability
101 NOTE ME equipment includes those accessories as defined by the manufacturer that are necessary to enable the normal use
102 of the ME equipment.
103 [EN 60601-1:2006]
———————
2)
Will be superseded by HD 60364-6:2006, Low voltage electrical installations – Part 6: Verification (based on
IEC 60364-6:2006, mod.) on 2009-09-01.
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104 710.3.4
105 applied part
106 part of medical electrical equipment that in normal use necessarily comes into physical contact with
107 the patient for ME equipment or an ME system to perform its function
108 [EN 60601-1:2006, definition 3.8]
109 710.3.5
110 group 0
111 medical location where no applied parts are intended to be used and where discontinuity (failure) of
112 the supply cannot cause danger to life
113 710.3.6
114 group 1
115 medical location where discontinuity of the electrical supply does not represent a threat to the safety of
116 the patient and applied parts are intended to be used as follows:
117 − externally,
118 − invasively to any part of the body, except where 710.3.7 applies
119 710.3.7
120 group 2
121 medical location where applied parts are intended to be used in applications such as intracardiac
122 procedures, vital treatments and surgical operations where discontinuity (failure) of the supply can
123 cause danger to life
124 NOTE An intracardiac procedure is a procedure whereby an electrical conductor is placed within the heart of a patient or is
125 likely to come into contact with the heart, such conductor being accessible outside the patient’s body. In this context, an
126 electrical conductor includes insulated wires such as cardiac pacing electrodes or intracardiac ECG electrodes, or insulated
127 tubes filled with conducting fluids.
128 710.3.8
129 medical electrical system (ME system)
130 combination, as specified by its manufacturer, of items of equipment, at least one of which is medical
131 electrical equipment to be inter-connected by functional connection or by use of a multiple socket-
132 outlet
133 [EN 60601-1:2006, definition 3.64]
134 NOTE The system includes those accessories which are needed for operating the system and are specified by the
135 manufacturer.
136 710.3.9
137 patient environment
138 any volume in which intentional or unintentional contact can occur between a patient and parts of the
139 medical electrical equipment or medical electrical system or between a patient and other persons
140 touching parts of the medical electrical equipment or medical electrical system
141 [EN 60601-1:2006, definition 3.79]
142 NOTE 1 For illustration see Figure 710A.
143 NOTE 2 This applies when the patients position is pre-determined, if not, all possible patient positions should be considered.
144 710.3.10
145 medical IT system
146 IT electrical system fulfilling specific requirements for medical applications
147 NOTE These supplies are also known as isolated power supply systems.
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148 710.30 Assessment of general characteristics
149 Allocation of group numbers and classification of safety services to a medical location shall be made in
150 agreement with the medical staff and the authority responsible for safety. In order to determine the
151 classification of a medical location, it is necessary that the medical staff indicate which medical
152 procedures will take place within the location. Based on the intended use, the appropriate
153 classification for the location shall be determined.
154 NOTE 1 Classification of a medical location should be related to the type of contact between applied parts and the patient, as
155 well as the purpose for which the location is used (Guidance on the allocation of a group number and classification of safety
156 services for medical locations is shown in Annex B).
157 NOTE 2 To ensure protection of patients from possible electrical hazards, additional protective measures need to be applied in
158 medical locations. The type and description of these hazards can vary according to the treatment being administered. The
159 purpose for which a location is to be used may justify areas with different classifications (group 0, 1 or 2) for different medical
160 procedures.
161 NOTE 3 Applied parts are defined by the particular standards for medical electrical equipment.
162 NOTE 4 The possibility that certain medical locations could be used for different purposes which necessitate a higher group
163 should be addressed by risk management
164 710.31 Purposes, supplies and structure
165 710.312.2 Types of system earthing
166 The TN-C system is not allowed in medical locations and medical buildings downstream of the main
167 distribution board.
168 NOTE Main distribution board is a board in the building which fulfils all the functions of a main electrical distribution for the
169 supplied building area assigned to it and where the voltage drop is measured for operating the main safety service.
170 710.313 Power supply
171 710.313.1 General
172 In medical locations the distribution system should be designed and installed to facilitate the automatic
173 change-over from the main distribution network to the electrical safety source feeding essential loads
174 (according to IEC 60364-5-55:2001, Clause 556).
175 710.4 Protection for safety
176 710.41 Protection against electric shock
177 710.410.3 General requirements
178 Add:
179 Protection by insulation of live parts, according to HD 60364-4-41:2007, Clause A.1, or protection by
180 barriers or enclosures, according to HD 60364-4-41:2007, Clause A.2, are permitted.
181 NOTE Class II equipment is also permitted.
182 710.410.3.5
183 The protective measures "obstacles" and "placing out of reach" as specified in HD 60364-4-41:2007,
184 Annex B, shall not be applied.
185 710.410.3.6
186 The protective measures "non-conducting location", "earth-free local equipotential bonding" and
187 "electrical separation for the supply of more than one item of current-using equipment" as specified in
188 HD 60364-4-41:2007, Annex C, shall not be applied.
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189 710.411.3 Requirements for fault protection (protection against indirect contact)
190 710.411.3.2 Automatic disconnection in case of a fault
191 710.411.3.2.1
192 Add:
193 Care shall be taken to ensure that simultaneous use of many items of equipment connected to the
194 same circuit cannot cause unwanted tripping of the residual current protective device (RCD).
195 In medical locations of group 1 and group 2, where RCDs are required, only type A or type B shall be
196 selected, depending on the possible fault-current arising.
197 710.411.3.2.5
198 Add:
199 In medical locations of group 1 and group 2, the following shall apply:
200 − for IT, TN and TT systems, the conventional touch voltage U shall not exceed 25 V a.c.
L
201 (U ≤ 25 V a.c.) or 60 V d.c. (UL ≤ 60 V d.c.);
L
202 − for TN and IT systems, HD 60364-4-41:2007, Table 41.1, shall apply.
203 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 equipotential
L L
204 bonding, by complying with the disconnection time in accordance with the general standard.
205 710.411.3.3
206 Where medical IT-System is used for protective measure this clause is not applicable.
207 710.411.4 TN system
208 In final circuits of group 1 rated up to 63 A residual current protective devices with a rated residual
209 operating current not exceeding 30 mA shall be used (this covers also additional protection).
210 In medical locations of group 2 protection by automatic disconnection of supply by means of residual
211 current protective devices with a rated residual-operating current not exceeding 30 mA may only be
212 used on the following circuits:
213 − circuits for the supply of operating tables;
214 − circuits for X-ray units;
215 NOTE 1 The requirement is mainly applicable to mobile X-ray units brought into group 2 locations.
216 − circuits for large equipment with a rated power greater than 5 kVA.
217 NOTE 2 It is recommended that TN-S systems are monitored to ensure the insulation level of all live conductors and that a
218 decrease should be reported to technical staff.
219 710.411.5 TT system
220 Add:
221 In medical locations of group 1 and group 2 residual current protective devices shall be used as
222 disconnection devices and the requirements of TN system (see 710.411.4) apply.
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223 710.411.6 IT system
224 710.411.6.3.1
225 Add:
226 In group 2 medical locations, the medical IT system shall be used for final circuits supplying medical
227 electrical equipment and systems intended for life support, surgical applications and other electrical
228 equipment located in the "patient environment", excluding equipment listed in 710.411.4.
229 For each group of rooms serving the same function, at least one separate medical IT system is
230 necessary. The medical IT system shall be equipped with an insulation monitoring device (IMD) in
231 accordance with EN 61557-8 with the following additional specific requirements:
232 − a.c. internal impedance shall be ≥ 100 kΩ;
233 − internal resistance shall be ≥ 250 kΩ;
234 − test voltage shall be ≤ 25 V d.c.;
235 − injected current, even under fault conditions, shall be ≤ 1 mA peak;
236 − indication shall take place at the latest when the insulation has decreased to 50 kΩ. If the
237 response value is adjustable, the lowest possible setpoint value shall be ≥ 50 kΩ. A test device
238 shall be provided;
239 − response and alarm-off time shall be ≤ 5 s.
240 NOTE 1 An indication is recommended if the protective earth (PE) or wiring connection of the IMD is lost.
241 NOTE 2 The necessary additional requirements on IMDs given above are at this time not covered in the equipment standard
242 EN 61557-8:1997. They will be removed from this publication as soon as they have been treated in the relevant equipment
243 standard.
244 NOTE 3 National regulations ensuring equivalent safety may apply.
245 For each medical IT system, an acoustic and visual alarm system incorporating the following
246 components shall be arranged at a suitable place so that it can be permanently monitored (audible
247 and visual signals) by the medical staff and furthermore is forwarded to the technical staff:
248 − a green signal lamp to indicate normal operation;
249 − a yellow signal lamp which lights when the minimum value set for the insulation resistance is
250 reached. It shall not be possible for this light to be cancelled or disconnected;
251 − an audible alarm which sounds when the minimum value set for the insulation resistance is
252 reached. This audible alarm may be silenced;
253 − the yellow signal shall go out on removal of the fault and when the normal condition is restored.
254 Monitoring of overload or high temperature for the medical IT-transformer is required. Monitoring of
255 both is recommended.
256 Fault location systems which localize insulation faults in any part of the medical IT system may also be
257 installed in addition to an insulation monitoring device.
258 The insulation fault location system shall be in accordance with EN 61557-9.
259 710.411.7 Functional extra-low voltage (FELV)
260 In medical locations functional extra-low voltage (FELV) is not permitted.
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261 710.414 Protective measures: extra-low-voltage provided by SELV and PELV
262 710.414.1 General
263 Add:
264 When using SELV and/or PELV circuits in medical locations of group 1 and group 2, the nominal
265 voltage applied to current-using equipment shall not exceed 25 V r.m.s. a.c. or 60 V ripple free d.c.
266 Protection by basic insulation of live parts according to HD 60364-4-41:2007, Clause A.1, and by
267 barriers or enclosures according to HD 60364-4-41:2007, Clause A.2, is essential.
268 710.414.4.1
269 Add:
270 In medical locations of group 2, where PELV is used, exposed-conductive-parts of equipment (e.g.
271 operating theatre luminaries), shall be connected to the protective bonding conductor.
272 710.415.2 Additional protection: supplementary protective bonding conductor
273 710.415.2.1
274 Add:
275 In each medical location of group 1 and group 2, supplementary protective equipotential bonding shall
276 be installed and the protective bonding conductors shall be connected to the equipotential bonding
277 busbar for the purpose of equalizing potential differences between the following parts, located in the
278 “patient environment”:
279 − protective conductors;
280 − extraneous-conductive-parts;
281 − screening against electrical interference fields, if installed;
282 − connection to conductive floor grids, if installed;
283 NOTE 1 If due to floor grid connection to the supplementary equipotential bonding an earth loop is formed, then the
284 connection may be disregarded.
285 − metal screens of isolating transformers, via the shortest way to PE-line.
286 A sufficient number of supplementary equipotential bonding connection points for the connection of
287 medical electrical equipment shall be available in group 2 and are recommended in group 1 (see also
288 710.30).
289 NOTE 2 Fixed conductive non-electrical patient supports such as operating theatre tables, physiotherapy couches and dental
290 chairs should be connected to the equipotential bonding conductor unless they are intended to be isolated from earth.
291 710.415.2.2
292 Replace the text by the following:
293 In medical locations of group 1, the resistance of the conductors, including the resistance of the
294 connections, between the terminals for the protective conductor of socket-outlets and of fixed
295 equipment or any extraneous-conductive-parts and the equipotential bonding bus bar shall not exceed
296 0,7 Ω.
297 NOTE National regulations ensuring equivalent safety may apply.
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298 In medical locations of group 2, the resistance of the conductors, including the resistance of the
299 connections, between the terminals for the protective conductor of socket-outlets and of fixed
300 equipment or any extraneous-conductive-parts and the equipotential bonding bus bar shall not exceed
301 0,2 Ω.
302 Add:
303 710.415.2.3
304 The equipotential bonding busbar shall be located in or near the medical location. Connections shall
305 be so arranged that they are accessible, labelled, clearly visible and can easily be disconnected
306 individually.
307 NOTE 1 It is recommended to use star-shaped or tree-shaped wiring and avoid ”earth-loops”.
308 NOTE 2 For rooms used for intracardiac procedures special national requirements to isolate the equipotential bonding bus bar
309 may apply.
310 710.422 Fire protection
311 National legislation providing additional requirements may exist.
312 710.444 Protection against electro-magnetic interferences (EMI) in installations of
313 buildings
314 NOTE Disturbances are not expected, if the magnetic induction B at 50 Hz is not exceeding the following values at the patient
315 position:
-7
316 − Btt = 1 • 10 Tesla for Electromyogram (EMG);
-7
317 − Btt = 2 • 10 Tesla for Electroencephalogram (EEG);
-7
318 − Btt = 4 • 10 Tesla for Electrocardiogram (ECG).
319 In general these limit values are not exceeded, if the following minimum distances in all directions are observed between
320 electrical equipment, which can cause magnetic disturbances, and the places of patient examination.
321 a) When foremost inductive equipment with large output is used, a distance of 6 m in general is sufficient.
322 Examples of such equipment:
323 − transformer of the electrical power installation, e.g. of the IT system;
324 − permanently installed motors, especially motors with nominal output exceeding 3 kW.
325 b) Between multi-strand cables and lines of the electrical power installation and patient positions to be protected:
Conductor cross section Min. distance
10 mm² to 70 mm² 3 m
95 mm² to 185 mm² 6 m
> 185 mm² 9 m
326 Larger distances may be required with single conductors. If there is a requirement to check the adherence of limit values, it is
327 recommended to commission experts.
328 See EN 50174-2 for additional information.
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329 710.5 Selection and erection of electrical equipment
330 710.51 Common rules
331 710.51.1 Distribution boards
332 Distribution boards shall be in accordance with EN 60439 series or IEC 60670-24.
333 Distribution boards for group 2 shall be installed in close proximity to the group 2 medical locations
334 and clearly identified.
335 NOTE 1 Dedicated distribution boards should be provided for the general power supply and the safety power system.
336 NOTE 2 Distribution boards should preferably be installed outside medically used locations and be safely guarded against
337 unauthorized persons.
338 NOTE 3 Distribution board for medical location is a board which fulfils all the functions for the supplied medical location area
339 assigned to it and where the voltage drop is measured for operating the safety power system, if it necessary.
340 710.51.2 Electrical operating areas
341 Where electrical operating areas are arranged, national regulations prevail. If no national regulations
342 are available the following arrangements shall each be accommodated in their own enclosed electrical
343 operating areas:
344 − main t
...