30mm
20mm
15mm
15mm
10mm
Gulf StandardGSO IEC 60364-7-710:2024
Gulf StandardGSO IEC 60364-7-710:2024
Gulf StandardGSO IEC 60364-7-710:2024
GSO IEC 60364-7-710:2024Gulf Standard
International StandardIEC 60364-7-710:2021 ED2
Low-voltage electrical installations - 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 provide safety of patients and medical staff. These requirements refer to:
–
hospitals and clinics or equivalent institutions (including equivalent transportable and mobile locations);
which, subject to assessment (
710.30), can also include:
–
sanatoriums and health clinics;
–
dedicated locations in homes for senior citizens and aged care homes, where patients receive medical care;
–
medical centres, outpatients' clinics and departments, casualty wards;
–
other outpatients' institutions (industrial, sports and others);
–
medical and dental practices;
–
dedicated medical rooms in the workplace;
–
other locations where medical electrical equipment is used;
–
rooms in existing installations where a change of utilization for medical applications occur.
This list is not exhaustive.
The requirements of this document do not apply to ME equipment or ME systems.
NOTE 1ME equipment and ME systems are covered by IEC 60601 (all parts).
NOTE 2In the USA, the requirements of NFPA 70®, National Electrical Code® in general and specifically article 517 (Healthcare Facilities) apply.
710.2Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60050–826, International Electrotechnical Vocabulary – Part 826: Electrical installations (available at http://www.electropedia.org) IEC 60364‑1:2005, Low-voltage electrical installations – Part 1: Fundamental principles, assessment of general characteristics, definitions
IEC 60364‑4–41:2005, Low-voltage electrical installations – Part 4-41: Protection for safety – Protection against electric shock
IEC 60364‑4–41:2005/AMD1:2017
IEC 60364‑4–42:2010, Low-voltage electrical installations – Part 4-42: Protection for safety – Protection against thermal effects
IEC 60364‑4–42:2010/AMD1:2014
IEC 60364‑4–44:2007, Low-voltage electrical installations – Part 4-44: Protection for safety – Protection against voltage disturbances and electromagnetic disturbances
IEC 60364‑4–44:2007/AMD1:2015
IEC 60364-4-44:2007/AMD2:2018
IEC 60364‑5–51:2005, Electrical installations of buildings – Part 5-51: Selection and erection of electrical equipment – Common rules
IEC 60364‑5–52:2009, Low-voltage electrical installations – Part 5-52: Selection and erection of electrical equipment – Wiring systems
IEC 60364‑5–53:2019, Low-voltage electrical installations – Part 5-53: Selection and erection of electrical equipment – Devices for protection for safety, isolation, switching, control and monitoring
IEC 60364‑5–53:2019/AMD1:2020
IEC 60364‑5–56:2018, Low-voltage electrical installations – Part 5-56: Selection and erection of electrical equipment – Safety services
IEC 60364‑6:2016, Low voltage electrical installations – Part 6: Verification
IEC 60947–6–1, Low-voltage switchgear and controlgear – Part 6-1: Multiple function equipment – Transfer switching equipment
IEC 61439 (all parts), Low-voltage switchgear and controlgear assemblies
IEC 61557–8:2014, 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 61557–9:2014, 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 61558–2–15, Safety of transformers, reactors, power supply units and combinations thereof – Part 2-15: Particular requirements and tests for isolating transformers for the supply of medical locations
710.3Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60050–826, IEC 60364‑1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
710.3.1
location intended for purposes of diagnosis, treatment, monitoring and care of
patients 710.3.2
living being (person or animal) undergoing a medical, surgical or dental procedure
[SOURCE: IEC 60601‑1:2005, 3.76, modified – The note has been deleted.]
710.3.3
medical electrical 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: IEC 60601‑1:2005, 3.63, modified – Notes 2, 3, 4 and 5 have been deleted.]
710.3.4
[SOURCE: IEC 60601‑1:2005, 3.8, modified – The notes have been deleted.]
710.3.5
medical electrical 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: IEC 60601‑1:2005, 3.64, modified – The note has been deleted.]
710.3.6
Note 2 to entry: This applies where the
patient's position is pre-determined.
[SOURCE: IEC 60601‑1:2005, 3.79, modified – The notes have been added.]
710.3.8
medical location where
ME equipment or
ME systems are intended to be used externally or invasively on any part of the
patient and where discontinuity of the electrical supply, such as protection against electric shock, does not represent a risk to the safety of the
patient 710.3.9
medical location where
ME equipment or
ME systems are intended to be used intrusively, externally or invasively to any part of the
patient and where discontinuity of the electrical supply, such as protection against electric shock, represents a risk to the safety of the
patient 710.3.11
distribution board that fulfils all the functions of a main electrical distribution for the supplied area assigned to it and where the voltage is measured for operating the electric supply system for safety services
710.3.12
electric source for safety services
electric source intended to be used as part of an electric supply system for safety services
[SOURCE: IEC 60050–826:2004, 826-10-05]
710.3.13
medical insulation monitoring device
[SOURCE: IEC 61557–8:2014, 3.1.22, modified – "of a group 2 medical location" has been deleted]
710.3.14
insulation fault location system
device or combination of devices used for insulation fault location in IT systems, where the
insulation fault location system is used in addition to an insulation monitoring device and is used to locate insulation faults
Note 1 to entry: An IFLS injects a locating current between the electrical system and earth.
[SOURCE: IEC 61557–9:2014, 3.1.1]
710.3.15
uninterruptible power system
combination of convertors, switches and energy storage devices (such as batteries), constituting a power system for maintaining continuity of load power in case of input power failure
Note 1 to entry: Continuity of load power occurs when voltage and frequency are within rated steady-state and transient tolerance bands, and with distortion and interruptions within the limits specified for the output port. Input power failure occurs when voltage and frequency are outside rated steady-state and transient tolerance bands, or with distortion or interruptions outside the limits specified for the UPS.
[SOURCE: IEC 62040–1:2017, 3.101]
710.30Assessment of general characteristics
Add:
The designer, in conjunction with medical staff and the person(s) responsible for medical safety, shall consider what effects discontinuity of the electric supply will have on the ME equipment or ME systems including:
–
the duration of the discontinuity (failure) of the electrical supply;
–
the effect of any supply interruption on the treatment, monitoring or examination, including if any procedure repetition is hazardous to the patient or if it is impossible to repeat the examination results.
A comprehensive assessment shall be performed to identify the proper electrical supply requirements for the ME equipment, ME systems and supporting electrical equipment intended to be used.
Having identified these requirements, the appropriate classification for the medical location shall be determined. In order to determine the extent of a medical location, all possible patient positions shall be considered.
Where assessment shows any given location that falls into both group 1 or group 2 categories, the location shall be classified as group 2.
NOTE 1For the classification of electric supply systems for safety services, see
IEC 60364‑5–56 and
710.560.4.1.
NOTE 2Guidance on the allocation of a group number and classification of electric supply systems for safety services for medical locations is shown in Annex A.
710.31Purposes, supplies and structure
710.312.2Types of system earthing
Add:
A TN-C system shall not be used downstream of the main distribution board.
710.313Supplies
710.313.1General
Add:
710.313.1.101Supplies for electric supply systems for safety services and standby systems in medical locations of group 1 and group 2
In medical locations of group 1 and group 2, the distribution system shall be designed and installed to facilitate the automatic transfer switching or automatic change-over equipment from the main distribution network to the electric source for safety services feeding essential loads (see IEC 60364‑5–56). Consideration shall be given to all other essential medical and non-medical loads.
Consideration should also be given to the inrush current of any connected equipment.
NOTEThis could also apply to group 0 medical locations.
710.313.1.102Power supply for medical locations of group 2
In case of a single fault in the power supply, a total loss of power shall be prevented. This may be achieved by:
–
provision of two independent supply lines, and/or
•
a UPS within the same fire section for supplying the medical IT system, or
•
a UPS that supplies a number of group 2 locations.
710.314Division of installation
Add:
710.314.101Final circuits for ME equipment and ME systems shall be for the exclusive use of such equipment.
710.41Protection for safety – Protection against electric shock
710.410.3General requirements
710.410.3.5
Replace with:
The protective measures of "obstacles" and "placing out of reach" shall not be used.
710.410.3.6
Replace with:
The protective measures of "non-conducting location", "protection by earth-free local equipotential bonding" and "electrical separation for the supply of more than one item of current-using equipment", shall not be used.
710.411Protective measure: automatic disconnection of supply
710.411.3Requirements for fault protection
710.411.3.2Automatic disconnection in case of a fault
710.411.3.2.5
Replace with:
In medical locations of group 1 and group 2, where disconnection of the power supply cannot be achieved either by means of an overcurrent protection device in accordance with IEC 60364‑4–41:2005, 411.3.2 and IEC 60364‑4–41:2005/AMD1:2017, 411.3.2 or by means of a residual current protective device (RCD), the following applies.
–
For IT, TN and TT systems, the permissible touch voltage UL shall not exceed 25 V AC (UL ≤ 25 V AC) or 60 V DC (UL ≤ 60 V DC).
–
In TN systems, 25 V AC (UL ≤ 25 V AC) or 60 V DC (UL ≤ 60 V DC) can be maintained using supplementary protective equipotential bonding.
The provisions described in IEC 60364‑4–41:2005/AMD1:2017, Annex D, shall not be applied.
710.411.3.3Further requirements for socket-outlets and for the supply of mobile equipment for use outdoors
Add:
Where a medical IT system is used, additional protection by means of a residual current protective device (RCD) shall not be used.
710.411.4TN system
710.411.4.5
Add:
In group 1 and group 2 medical locations, protection with residual current protective devices (RCDs) for TN circuits shall be in accordance with IEC 60364‑4‑41:2005/AMD:2017, 411.3.2.
710.411.5TT system
710.411.5.2
Add:
In medical locations of group 1 or group 2, residual current protective devices (RCDs) for TT circuits shall be in accordance with IEC 60364‑4–41:2005, 411.3.2 and IEC 60364‑4–41:2005/AMD1:2017, 411.3.2.
710.411.6IT system
Add:
710.411.6.1.101Medical IT systems
In group 2 medical locations, a medical IT system, including the requirements of
710.411.6.3.101 and
710.512.1.101, shall be used for final circuits and where the same final circuit is connected to ME equipment or an ME system, located within the patient environment. Exceptions can be made for final circuits for
–
equipment with a rated power greater than 5 kVA,
–
the supply of the motors of fixed operating tables.
In medical locations of group 2, the supply to final circuits for socket-outlets for ME equipment and ME systems used for life-support of the patient, shall not be automatically disconnected in the event of a first fault.
710.411.6.3.101Medical insulation monitoring device
The medical IT system shall be equipped with a medical insulation monitoring device (MED-IMD) in accordance with IEC 61557–8:2014, Annex A and Annex B.
NOTE 1In addition to information given by a remote insulation warning, the following events could be constantly displayed:
–
status of the power supply lines for medical locations of group 2;
–
circuit breaker tripping;
–
other disorders that are important for the operation of the medical location;
–
malfunction of communication systems;
with the possibility to forward all information to technical staff.
An indelible and easily readable written explanation shall be provided in the medical location, which includes the meaning of each type of signal, alarm and the procedures to be followed in case of a first fault.
For transformers in accordance with IEC 61558–2–15 supplying a medical IT system, monitoring of overload and over temperature conditions shall be applied.
In a medical IT system, it is recommended to use an IFLS.
Where an insulation fault location system is installed, it shall be in accordance with IEC 61557–9:2014, Annex A.
NOTE 2An IFLS eases the location of the faults, especially in case of intermittent faults.
710.414Protective measure: extra-low-voltage provided by SELV and PELV
710.414.1General
Add:
710.414.1.101If SELV and/or PELV circuits in medical locations of group 1 and group 2 are used, the nominal voltage applied to current-using equipment shall not exceed 25 V RMS AC or 60 V ripple free DC. Protection by basic insulation of live parts in accordance with IEC 60364‑4–41:2005, Clause A.1 or by barriers or enclosures in accordance with IEC 60364‑4–41:2005, Clause A.2 shall be provided.
NOTERipple-free is conventionally defined as an RMS ripple voltage of not more than 10 % of the DC component.
710.414.4Requirements for SELV and PELV circuits
710.414.4.1
Add:
In medical locations of group 1 and group 2, where PELV is used, exposed-conductive-parts of equipment shall be connected to the equipotential bonding busbar via a protective bonding conductor.
710.415Additional protection
710.415.2Additional protection: supplementary protective equipotential bonding
Add:
710.415.2.101In each medical location of group 1 and group 2, a supplementary protective equipotential bonding system 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 located within the patient environment:
–
extraneous-conductive-parts, unless they are intended to be isolated from earth;
–
screens against electrical interference fields, if installed;
–
connection to conductive floor grids, mesh and tapes, including those for static protection, if installed;
–
metal screens of isolating transformers, cable shields, etc., via the direct path to the protective earthing conductor;
Conductive parts intended to be isolated from earth shall not be connected to supplementary protective equipotential bonding.
Supplementary equipotential bonding connection points for the connection of ME equipment shall be available in group 2 locations and considered in group 1.
710.415.2.102In medical locations of group 1 and group 2, the resistance between simultaneously accessible exposed-conductive-parts, including the terminals for the protective conductor of socket-outlets and of fixed equipment, extraneous conductive parts and the equipotential bonding points shall be of such a value to meet the requirements of
710.411.3.2.5 and shall not exceed 0,2 Ω.
NOTEThe limit of 0,2 Ω is based on the use of a type B miniature circuit breaker rated current of 25 A to achieve the conventional touch voltage of 25 V AC.
National regulations may require other values.
710.415.2.103The equipotential bonding busbar shall be located within or near each medical location of group 1 and group 2. Connections shall be so arranged that they are accessible, labelled, clearly visible and that they can easily be individually disconnected.
710.42Protection for safety – Protection against thermal effects
710.421Protection against fire caused by electrical equipment
710.421.1General requirements
Add:
710.421.7.101Arc fault detection devices (AFDDs) shall not be used in circuits supplied by IT systems specified as medical IT systems in
710.411.6.
In circuits not supplied by medical IT systems, any use of an arc fault detection device (AFDD) shall be subject to a risk assessment.
NOTERisk assessments could involve the participation of fire inspectors, designers, architects and stakeholders.
Additional national legislation shall be observed.
710.44Protection for safety – Protection against voltage disturbances and electromagnetic disturbances
710.444Measures against electromagnetic influences
710.444.1General
Add:
Special consideration shall be given to electromagnetic interference and electromagnetic compatibility. Further information is provided in Annex B.
NOTEInformation about electrostatic control in healthcare can be found in IEC 61340 (all parts).
710.51Selection and erection of electrical equipment – Common rules
Add:
710.51.101Distribution boards
710.51.101.1General
Distribution boards shall be in accordance with IEC 61439 (all parts).
Separate distribution boards shall be provided for the general power supply and the electric supply system for safety services.
710.51.101.2Medical locations of group 2
Distribution boards for group 2 medical locations shall be installed in close proximity to the areas they serve and be clearly labelled. Distribution boards shall be installed outside the group 2 medical locations and should be safely secured against operation by unauthorized persons.
The medical IT distribution board should be located within 25 m of the area it serves. Leakage currents should be taken into consideration.
NOTE 1The 25 m are related to possible capacitive leakage current.
Recommendations for the minimum distances from the isolating transformers of the medical IT system to the equipment used within the patient environment are shown in informative Annex B.
The distribution board should be easily accessible for maintenance and be located on the same level and within the same fire compartment as the load it serves.
NOTE 2A distribution board for medical locations is one that fulfils the functions for the supplied medical location area assigned to it and where the main power supply voltage is monitored for operating the change-over to the electric supply system for safety services in accordance with
710.313.1.101 and
710.313.1.102.
710.51.102Electrical operating areas
Where electrical operating areas are provided, national regulations prevail. If no national regulations are available the following arrangements, if any, shall each be accommodated in their own enclosed electrical operating area:
–
switching stations with nominal voltages above 1 kV;
–
main distribution board for the general power supply including the sub-distribution board for this floor section, power factor correction and harmonic filtering;
–
main distribution board for the electric supply system for safety services including the sub-distribution board for this floor section;
–
stationary generating set for the electric supply system for safety services;
–
central batteries for the electric supply system for safety services, if the type of construction requires accommodation in an enclosed electrical operating area, as well as converter and control cabinets for the additional electric supply system for safety services.
710.512Operational conditions and external influences
710.512.1Operational conditions
Add:
710.512.1.101Isolating transformer for medical IT systems
Isolating transformers shall be in accordance with IEC 61558–2–15 and fulfil the following requirements.
At least one single-phase transformer shall be used for each medical IT system to supply equipment. The rated output shall not be less than 0,5 kVA and shall be limited to 10 kVA. Where several transformers are needed to supply equipment in one medical location, they shall not be connected in parallel.
However, if national regulations allow a three-phase transformer to be applied for the supply of single-phase loads, the construction or the method of connection shall be such, that no voltage increases to more than 250 V on the load side, 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 connection 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.
NOTEThe selection of an isolating transformer for medical IT systems with a short-circuit voltage suitable for the protection against overcurrent of the primary side and those of the final circuits is suitable for the design of the medical IT system.
710.512.2External influences
Add:
710.512.2.101Explosion risk
Additional precautions should be considered where hazardous conditions are likely to occur.
Electrical devices (socket-outlets and switches) installed all around 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), to minimize the risk of ignition of flammable gases.
NOTEFor medical supply units see ISO 11197.
710.514Identification
710.514.3Identification of neutral and protective conductors
Add:
710.514.3.101Protective bonding conductors for supplementary bonding shall be identified by the bi-colour combination GREEN-AND-YELLOW at least at the points of connection.
NOTESee IEC 60445:2017, Clause 6 for identification by colours of protective conductors.
710.514.5Diagrams
Add:
710.514.5.101Diagrams and documentation
In the absence of any national regulation, 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 diagrams showing distribution circuits of the normal (main) power supply and electric supply system for safety services in a single-line representation. These diagrams shall contain information on the location of all distribution boards;
–
all main distribution board block diagrams showing switchgear and controlgear and distribution boards in a single-line representation;
–
circuit diagrams of controls;
–
documentation showing verification of compliance with the requirements of standards (e.g. with
710.411);
–
list of loads permanently connected to the electric supply system for safety services indicating the normal currents and, in the case of motor-operated loads, the starting currents;
–
list of circuit breaker settings;
–
functional description for the operation of the electric sources for safety services and of the electric supply system for safety services.
710.514.5.102Operating instructions
Instructions for operation and maintenance of the electrical installation shall be provided. The documents should include:
–
instructions for operation, inspection, testing and maintenance of storage batteries and electric supply system for safety services, including the automatic transfer switching or automatic change-over equipment;
–
a logbook containing a record of all tests and visual inspections;
–
information regarding visual inspection(s).
710.52Selection and erection of electrical equipment – Wiring systems
710.520.4General
Add:
Any wiring system within group 2 medical locations shall be exclusive to the use of equipment and accessories in that location.
710.53Selection and erection of electrical equipment – Devices for protection for safety, isolation, switching, control and monitoring
710.531Equipment for protection against electric shock
710.531.2Devices for automatic disconnection of supply
710.531.2.2Overcurrent protective devices
710.531.2.2.3IT system
Add:
710.531.2.2.3.101Medical IT systems
Overcurrent protective devices may be used in the primary side of the isolating transformer for medical IT systems for short-circuit protection only.
Overload protection shall not be installed in the secondary circuit of the isolating transformer for medical IT systems.
Overcurrent protection against short-circuit and overload current shall be used for each final circuit.
A 2-pole circuit-breaker shall be installed for each final circuit of single-phase supplies.
710.531.2.3Residual current protective devices
710.531.2.3.3Types of RCDs
Add:
710.531.2.3.3.101Selection of residual current protective devices in medical locations
In medical locations of group 1 and group 2, where residual current protective devices are required, RCDs shall be selected according to the possible fault current arising. RCDs of type AC shall not be used.
In group 1 medical locations, it is permissible to use residual current protective devices (RCDs) in final circuits with overcurrent protective devices rated above 32 A.
Consideration should be given to limiting the number of socket-outlets on one final circuit to reduce the possibility of unwanted tripping of the residual current protective device (RCD) by the simultaneous use of multiple equipment.
Where residual current protective devices (RCDs) are used in medical locations of group 2, each individual ME equipment or ME system shall be protected by a dedicated residual current protective device (RCD).
The ease and procedure for resetting any residual current protective device (RCD) shall be considered and documented.
710.531.7Monitoring devices
Add as a paragraph:
In medical IT systems, the insulation shall be monitored with a MED-IMD in accordance with IEC 61557–8:2014, Annex A and Annex B. The MED-IMD shall be installed in the medical IT system distribution board.
710.535Co-ordination of protective devices
710.535.1Selectivity between overcurrent protective devices
Add:
710.535.1.101Selectivity between overcurrent protective devices of group 2 medical locations
In order to comply with the requirements for continuous supply of medical locations of group 2, full selectivity shall be ensured for any prospective overcurrent. In case of a short-circuit in a final circuit, the incoming circuits of the upstream distribution board shall not be interrupted.
710.536Isolation and switching
Add:
710.536.101Automatic transfer switching or automatic change-over equipment
In medical locations, where automatic transfer switching or automatic change-over equipment is installed, the following shall apply.
–
The automatic transfer switching or automatic change-over equipment shall comply with IEC 60947–6–1.
–
The wiring system between the automatic transfer switching or automatic change-over equipment and the subsequent overcurrent protection device shall be installed in an inherently short circuit and earth-fault free manner.
–
The automatic transfer switching or automatic change-over equipment shall be arranged so that safe separation between supply-lines is maintained.
–
Arrangements to allow for the maintenance of automatic transfer switching or change-over equipment shall be considered, for example, a bypass could be implemented.
710.537Monitoring
710.537.1General
710.537.1.3Selection of residual current monitoring devices (RCMs)
Add:
710.537.1.3.101Selection of residual current monitoring devices (RCMs) in group 1 and group 2 medical locations
In group 1 or group 2 medical locations, it is recommended to use residual current monitoring devices (RCMs) in accordance with
IEC 62020‑1. Any significant reduction of the insulation should be reported to the users and technical staff. The acoustic and visual alarm requirements of
710.411.6.3.101 are recommended if used in group 2 medical locations.
Where a residual current monitoring device (RCM) is used, the RCM type shall be selected according to the possible fault current arising, for example type A or type B.
710.55Selection and erection of electrical equipment – Other equipment
Add:
710.55.101Socket-outlets in medical locations of group 2
710.55.101.1Socket-outlets in Medical IT systems
In medical IT systems, a signal lamp or display shall be fitted to indicate the availability of supply for each final circuit supplying socket-outlets intended for ME equipment.
NOTEWhere socket-outlets are fitted with supply indicator luminaires, the emission of green light is preferred.
Switched socket-outlets shall not be used for medical IT systems.
The configuration of socket-outlets shall be as follows:
–
a single socket-outlet supplied by an individually protected circuit; or
–
several socket-outlets separately supplied by a minimum of two final circuits, with a maximum of six socket-outlets per final circuit.
710.55.101.2TN-S or TT systems
Socket-outlets for TN-S or TT systems shall either be:
–
incompatible with those used for medical IT systems; or
–
clearly and permanently marked, for example by colour coding.
710.559Luminaires and lighting installations
Add:
710.559.101Lighting circuits
In medical locations of group 1 and group 2 a minimum of two lighting circuits shall be provided by at least two different sources of supply.
The transfer time and level of illumination provided should be considered and aligned with national regulations.
710.56Selection and erection of electrical equipment – Safety services
710.560.4Classification
710.560.4.1
Replace by:
The classification of an electric supply system for safety services for medical locations are as follows:
–
class A – no-break: an automatic supply system which can ensure a continuous supply within specified conditions during the period of transition;
–
class C – short break: an automatic supply system available within 0,5 s;
–
class E – medium break: an automatic supply system available within 15 s;
–
class F – long break: an automatic supply system available in more than 15 s.
Electric supply systems for safety services provided for medical locations having differing classifications should meet the classification that gives the highest security of supply.
710.560.5General
Add:
710.560.5.101In medical locations, an electric supply system for safety services that, in accordance with this document, will energize the installations needed for continued operation in case of failure of the general power system, for a defined period within a pre-set switch-over time, is required.
The electric source for safety services shall automatically take over, if the voltage of one or more incoming line conductors of the main distribution board of the building with the main power supply drops to less than 85 % of the nominal voltage and during more than 0,5 s.
In group 1 medical locations outside hospitals or equivalent institutions, it may not be necessary to install any electric source for safety services, where failure of the supply presents no threat to safety.
Procedures for the periodic verification, planned maintenance and also possible emergency failures of the electric sources for safety services and the electric supply system for safety services should be in place.
710.560.6Electrical sources for safety services
Add:
710.560.6.101In case of a failure of the general power supply source, the electric source for safety services shall be energized to feed the equipment stated in
710.560.6.103.1,
710.560.6.103.2 and
710.560.6.103.3 with electric energy for a defined period of time and within a pre-determined transfer time.
NOTEFor more information on interconnecting cables between the individual components and subassemblies of the electric source for safety services, see IEC 60364‑5–52.
710.560.6.102Socket-outlets supplied from an electric source for safety services shall also be readily identifiable according to their safety services classification, for example by colour coding or labelling.
NOTEAdditional national requirements can be applicable.
710.560.6.103Detailed requirements for the electric source for safety services
710.560.6.103.1Transfer time is less than or equal to 0,5 s.
If the voltage drops below 85 % of the nominal voltage at the distribution board, an electric source for safety services that can provide a power supply for a period of at least 3 h shall be used for:
–
luminaries of operating theatre tables;
–
ME equipment and ME systems containing light sources or equipment essential to the procedure; as an example, this equipment may include endoscopes and essential equipment such as monitors;
–
critical life-supporting ME equipment and ME systems.
NOTEAssessment (
710.30) can identify other equipment requiring connection to an electric source for safety services with the above requirements.
The power supply shall be connected automatically within a transfer time not exceeding 0,5 s.
The duration of 3 h may be reduced to 1 h, if an independent electric source for safety services in accordance with
710.560.6.103.2 is installed.
710.560.6.103.2Transfer time is less than or equal to 15 s.
ME equipment and ME systems not connected to an electric source for safety services in accordance with
710.560.6.103.1 and applications in accordance with
710.560.9 shall be connected automatically and within 15 s to an electric source for safety services, which can maintain the connection for a minimum period of 24 h, when the voltage of one or more line conductors at the main distribution board for the electric source for safety services drops to less than 85 % of the nominal voltage and for more than 3 s.
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.
710.560.6.103.3Transfer time is longer than 15 s.
Equipment, other than those covered by
710.560.6.103.1 and
710.560.6.103.2, which is essential to maintain medical operations or equivalent services, shall be connected automatically (or manually) to an electric source for safety services, which can maintain the connection for a minimum period of 24 h. This equipment may include, for example:
–
technical building installations, in particular air conditioning, heating and ventilation systems, building services and waste disposal systems;
–
storage battery chargers;
–
fireman's lift or patient bed lift.
A risk assessment could lead to an extension of this 24 h period.
710.560.6.104Additional requirements for electric sources for safety services of medical locations of group 1 and group 2
An additional main incoming power supply such as an independent normal supply is not regarded as an electric source for safety services.
NOTEFor the use of unit-type power stations with jacking-piston combustion engines as an electric source for safety services, see ISO 8528‑1. For ratings of supplied power for specifications for prime power (PRP), see ISO 8528‑1:2018, 14.3.3.
710.560.6.1
Add:
Primary cells shall not be used as an electric source for safety services.
710.560.6.11
Add:
Where a UPS is used, it shall:
f)
be possible to start the UPS without any upstream supply available.
710.560.6.13
Add:
The availability (readiness for service) of the electric source for safety services shall be monitored and indicated at a suitable location.
710.560.9Emergency lighting applications
Add:
710.560.9.101Safety lighting
In the event of mains power failure, the transfer time to the electric source for safety services shall not exceed 15 s. The necessary minimum illuminance shall comply with national requirements and be provided for the following locations:
–
locations for switchgear and controlgear for emergency generating sets and for main distribution boards of the normal power supply and for the electric supply system for safety services;
–
locations intended for essential services. In each such location at least one luminaire shall be supplied from the electric source for safety services;
–
locations of central fire alarm and monitoring systems;
–
rooms of medical locations of group 1. In each such room at least one luminaire shall be supplied from the electric source for safety services;
In medical locations of group 1 outside hospitals or equivalent institutions, it may not be necessary to install any electric supply system for safety lighting and emergency escape lighting, if a failure of the supply does not prevent ending the procedure and safely evacuating the location.
–
rooms of medical locations of group 2. A minimum of 50 % lumen shall be supplied from the electric source for safety services.
If selective protection by disconnection of supply is applicable, it shall be so arranged that the protective equipment does not disconnect all the lighting circuits of the room or escape route.
NOTENational regulations can require shorter transfer times.
710.6Verification
710.6.4Initial verification
Add:
710.6.4.101Initial verification shall be carried out in accordance with national regulations. If no national regulations exist, the following inspections and tests are recommended.
The tests specified under items a) to h) and in addition to the requirements of IEC 60364‑6, shall be carried out and recorded, both prior to commissioning and after alterations or repairs and before re-commissioning:
a)
functional test of change-over devices in accordance with the manufacturer's instructions;
b)
functional test of MED-IMD and the overload monitoring systems of medical IT systems and acoustical/visual alarm systems as recommended by the manufacturer;
d)
verification of the integrity of the facilities for equipotential bonding required by
710.415.2.101;
e)
verification of the integrity of the facilities for the electric supply system for safety services required by
710.56;
f)
mathematical verification of the compliance of the selectivity of the electric supply system for safety services regarding planning documents and calculation;
g)
mathematical verification of the applied protective measures for compliance with the requirements for medical locations of group 1 and group 2 with attention to the requirements of
710.535.1;
h)
visual verification that the marking of the rating of the isolating transformer is in accordance with
710.512.1.101 and design documents.
710.6.5Periodic verification
Add:
710.6.5.101
NOTEThe procedures for the periodic inspection are usually done in close cooperation with the medical staff so that the risk for patients is reduced to a minimum.
The procedures for periodic inspection shall be carried out in accordance with national regulations.
Items a) to i) are recommended:
a)
functional testing of change-over devices: in accordance with the manufacturer's instructions and at least every 12 months;
b)
functional testing of the medical insulating monitoring devices (MED-IMD) and overload monitoring system of medical IT systems and acoustical/visual alarm systems: 12 months;
c)
measurement verifying the supplementary equipotential bonding: 36 months;
d)
verifying integrity of facilities required for equipotential bonding: 36 months;
e)
monthly functional testing of electric supply system for safety services in accordance with the manufacturer's instructions:
–
for a UPS and combustion engines: at least 80 % of the rated power;
–
batteries: a minimum of 15 min;
–
combustion engines: a minimum of 60 min;
A risk assessment is required before testing standby generators in long-term parallel with the grid.
f)
annual functional testing of the electric supply system for safety services in accordance with the manufacturer's instructions:
–
for a UPS and combustion engines: at least 80 % of the rated power;
–
batteries: capacity test for a minimum of 15 min;
–
combustion engines, until rated running temperature is achieved: endurance run for a minimum of 120 min;
–
generators black start testing: at least once every 12 months;
A risk assessment is required before testing standby generators in long-term parallel with the grid.
g)
checking the tripping of RCDs at IΔn: according to the manufacturer's instructions and at least every 12 months;
h)
visual inspection, functional tests and measurements of the electrical installation, especially to verify the protection against electric shock, including the settings of adjustable protective devices: at least 12 months;
i)
functional test of the lighting of exit signs, escape routes, locations for switchgear and control gear: 12 months.
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Figure 710.1 — Example of a patient environment |
NOTEThe dimensions show the minimum extent of the patient environment in a free surrounding.
SOURCE: IEC 60061‑1:2005, Figure A.9. |