Medical Electrical Installation Guidance Notes: Meigan'
Medical Electrical Installation Guidance Notes: Meigan'
Medical Electrical Installation Guidance Notes: Meigan'
Installation
Guidance Notes
‘MEIGaN’
Version 1.0
June 2005
Table of contents
3 Introduction......................................................................................................... 5
3.1 Background ......................................................................................................5
3.2 Document scope...............................................................................................5
3.3 Use of the document ........................................................................................6
4 Mains supply....................................................................................................... 6
4.1 Source of supply...............................................................................................6
4.2 Mains cables.....................................................................................................6
4.3 Mains supply quality .........................................................................................7
4.4 Mains supply impedance ..................................................................................7
4.5 Crimped connections........................................................................................8
4.6 Mains supply isolator and contactor .................................................................8
4.7 Contactor control circuit....................................................................................8
4.8 Over-current protection.....................................................................................9
4.9 Mains supply monitoring...................................................................................9
6 Socket-outlets................................................................................................... 14
6.1 Numbers and positions of socket-outlets........................................................14
6.2 Accessory boxes ............................................................................................15
6.3 Socket-outlet cable(s).....................................................................................15
6.4 MR diagnostic rooms......................................................................................15
6.5 Device mounted socket-outlets ......................................................................15
13 Glossary ............................................................................................................ 25
Team members
Charles Apps, Medical Device Specialist, MHRA
Fred Clarke, Consultant Radiology Engineer
Alan Denham, DHSS and PS (NI)
John Dunne, Consultant X-ray Engineer to NHSBSP
Mike Fitzgerald, St George’s Radiation Protection Centre
David Grainger, Senior Medical Device Specialist, MHRA
John Harper, Scottish Healthcare Supplies
Terry Hartshorn, Siemens Medical Solutions
Chris Holme, Principal Engineer (Electrical), NHS Estates
Mel King, Senior Medical Device Specialist, MHRA
Chris Lawinski, Consultant Physicist, KCARE
Jim Lefever, Senior Medical Device Specialist, MHRA
Brian Mansfield, Consultant Radiology Engineer
Dr Richard Mellish, Standards Manager, MHRA
Gavin McNally, Clinical Engineering Manager, DHSS and PS (NI)
Ian Pattenden, Southern Service Manager, GE Medical Systems
John Povey, Philips Medical Systems
Peter Robinson, Genesis Medical Pre-Installation Ltd
Nigel Tomlinson, Principal Scientific Advisor, NHS Estates
Andrew Ward, Welsh Health Estates
3 Introduction
3.1 Background
Annex 1 of this document is based on IEC 60364-7-710 and IEE Guidance Note 7. It
will be incorporated in a subsequent revision of HTM 2007.
This document, in conjunction with the above, replaces the electrical requirements of
TRS 89, which are no longer valid. Most of TRS 89 has been superseded by CE
marking. The remaining aspects of TRS 89 related to mechanical provisions will be
covered in a future publication.
The text within this document has been produced by the MHRA and representatives
from NHS Estates, the Scottish, Welsh and Northern Ireland administrations, NHS
electrical experts, medical device suppliers and pre-installation companies.
This guidance covers the electrical wiring and installation up to the terminals of
permanently installed medical devices and to the supply outlets for other medical
devices.
Purchasers and suppliers shall not change the original text. Any changes shall be
listed in an addendum.
Document support
Feedback and enquiries about this document are welcome at all times:
[email protected]
The electronic copy of this document in PDF format can be found on the MHRA
website: www.mhra.gov.uk
4 Mains supply
If both three-phase and single-phase supplies are needed in the same location, they
shall be derived from the same substation transformer.
All single-phase supplies within a medical location shall be from the same phase.
Mains cables shall be armoured or double insulated except where they are installed
in containment that provides an adequate degree of mechanical and electrical
protection.
The steel wire armour (SWA) shall not be used as the mains supply earth conductor.
Connection to earth shall be achieved by means of a separate copper conductor, of
the same cross sectional area as the phase conductors, unless the medical device
supplier specifies a greater cross sectional area. The copper earth conductor shall be
connected directly to the source of the supply unless it can be proved that a more
local distribution panel can provide a sufficiently sized copper earth conductor.
The conductors of three-phase cables shall be permanently identified as: L1, L2 and
L3 neutral as N and the earth by green/yellow insulation, as specified in BS 7671
Table 7A, Appendix 7. The phase conductor of the single-phase supply shall also be
identified as either L1, L2, or L3.
Room lighting or power cables shall not be contained in the medical device cable
containment.
Any of the following mains supply quality parameters that are specified by the
medical device manufacturer shall be checked for consistency with the
manufacturer’s specification:
• Supply frequency
• RMS phase voltage range
• RMS voltage sags
• RMS voltage surges
• Voltage unbalance
• Harmonic voltage distortion
• Voltage waveform profile
The mains impedance shall be measured (up to the room mains isolator) at the
earliest opportunity, so that the figure is available when reviewing the specification of
any imaging equipment on offer.
For imaging equipment that draws high currents, the mains supply impedance is
critical to the performance of the device. In the case of new buildings the mains
impedance can be calculated from the design parameters.
A means of isolating and switching electrical supplies to the medical device(s) shall
be provided at the medical location, in accordance with IEE regulations, sited in a
position readily accessible to the operator. The isolator shall include a means to lock
it in an off position.
Some medical devices may remain powered up, even when the OFF button on the
equipment is pressed. In some equipment, parts of the equipment may remain
powered up for a short period, even when the mains isolator is operated. This is
because the unit incorporates a UPS (uninterruptible power supply).
Where the mains supply isolator is intended as the routine means for switching on
and switching off, it shall be of a grade suitable for frequent use. However, if a
contactor is the usual means for switching on and switching off, only the contactor
needs to be rated for frequent use.
Where equipment is installed in a separate equipment room, but the mains isolator is
located in the diagnostic or treatment area, the medical device supplier shall install
any equipment necessary to meet their own lock-out procedures
At least one red emergency off button shall be provided in the contactor control
circuit. Additional emergency off buttons may be added to the circuit as necessary.
These buttons may incorporate protective shrouds to prevent accidental activation
and a twist-to-release mechanism.
One contact of the red emergency off button shall be normally closed and part of the
self-holding circuit. Other contacts may be needed, as specified by the medical
device supplier.
The emergency off button shall terminate radiation and remove the mains supply to
the room or location.
When more than one medical device control console is located in the same
room/area/location, each ‘MAIN EQUIPMENT ON/OFF’ control shall be suitably
located to clearly discriminate between each medical device control console.
Some manufacturers will also provide an ‘Emergency Stop’ function as part of the
medical device, in which radiation is terminated, together with some functions, while
maintaining the mains supply to parts of the equipment. ‘Emergency Stop’ can be
activated by means of buttons that are part of the equipment, or by means of red
push buttons either in the control area or in a location close to the patient position.
Three-phase supplies feeding medical devices shall have a phase rotation and
voltage monitoring device installed. This device shall prevent the contactor from
energising with:
5.1 General
Earthing and equipotential bonding conductors shall not intentionally carry load or
control currents.
The earth loop impedance of the supply shall be equal to or less than the phase
impedance.
An earth reference bar (ERB) shall be provided. The ERB installation shall comply
with the following requirements:
2. The ERB shall be close to the mains supply isolator except with MR units.
See 5.8 Magnetic resonance requirements.
5. The ERB shall contain one or more (see Figure 1) connection bar(s) insulated
from the building earth, having a cross sectional area capable of carrying the
maximum rated current of the mains supply fuses. The links between the bars
shall be of equivalent cross sectional area. The additional smaller bar (see
9. All installed equipment shall be earthed to the ERB if there are any
conductive surfaces that are accessible to either patients or staff. This
includes warning lights, injectors, water baths, contrast media warming
equipment, viewing boxes, powered drug cabinets etc. All such items shall be
returned to the ERB by means of a cable having a cross sectional area
sufficient to ensure that the bonding resistance between any conductive
surface is less than 0.2 Ω or as specified by the equipment manufacturer.
10. All non-powered equipment with metal surfaces shall be similarly bonded to
the ERB. This includes protective screens (including wings), metal sinks and
work surfaces, heating pipes and radiators, water pipes, drug cupboards,
ceiling mounted hardware, conduits, trunking and cable trays, steelwork
above the ceiling line (cross-bonded), Unistrut or Marstrut (cross-bonded),
steel or wire basket cable trays, steel floor ducts (lids to be fly-lead tagged),
steel floor plates (in or below floor line), metal support plates, metal cable
outlet plates, metal suspended ceiling tiles (cross-bonded), ‘computer’ flooring
(cross-bonded). All such items shall be returned to the ERB by means of a
cable. Earthing by means of trunking, conduits, or screening is not sufficient.
Where more than one circuit protective conductor is required for a medical device, or
complete medical device system, the following connection bars are required:
The connection bars shall have tapped holes. Crimp terminals shall be made of
tinned copper.
Crimped connections shall comply with section 4.5 Crimped connections. The
crimped terminals shall be attached to the connection bars with brass or copper bolts
and flat brass washers, they shall all be of matching size.
The mains supply circuit protection conductor shall be connected directly to the
mains supply distribution board at the source of supply at one end, and the ERB at
the other.
The earth impedance between any socket-outlet earth and the ERB shall not exceed
0.1 Ω. Please refer to chapter 11 Testing and verification.
The installation of socket-outlets shall ensure that the circuit protective conductors
together with the equipotential bonding conductor achieve an earth resistance value
of less than 0.1 Ω between any socket-outlet and the ERB.
The ERB shall be located on the diagnostic room side of the Faraday cage at the
earth connection point specified by the manufacturer. The brass stud used to connect
each side of the Faraday cage is deemed as the incoming earth to the diagnostic
room. This stud shall be securely connected to the Faraday cage. The ERB case
shall not be metal due to potential interference with the high magnetic field. The
supply-side conductor shall be one cable directly connected to the incoming supply
equipotential conductor.
5.9 Radiotherapy
In radiotherapy installations, any ‘earth wands’ shall be connected to the earth point
on the treatment table provided by the medical device supplier.
An earth wand is an insulated solid metal rod connected to earth with a flexible
equipotential conductor. Used by authorised personnel to ensure that residual
voltages are discharged before working on equipment.
Where a medical gas pendant is installed within the patient environment (as defined
in HTM 2007 Associated Information, Part 3, diagram C) then an equipotential
bonding conductor shall be connected to the ERB.
6 Socket-outlets
The number and location of socket-outlets, including those in the control area and
any other equipment rooms, shall be sufficient to avoid the need for extension leads
and trailing wires, taking account of possible extra equipment such as computers that
act as part of the hospital information technology system and image display
equipment.
The assessment shall also establish how many of the socket-outlets need to be on
isolated power supply (IPS) circuit(s) and how many can be on circuits protected by
residual current devices (RCDs).
For circuits protected by RCDs, consideration shall be given to the risk that
aggregation of leakage currents from many items of equipment connected to the
same circuit may cause unwanted tripping of the RCD.
Tower-mounted socket-outlets shall be mounted at least 100 mm from the floor to the
bottom edge of the lowest socket-outlet.
This is to prevent the introduction of potential or current from the building earth.
Socket-outlet cables shall be of sufficient size to ensure earth impedance is less than
0.1 Ω from socket-outlet to ERB. The cable run shall be as short as possible.
If IPS supplies are to be used, compatibility with mains filtering of the MR equipment
shall be ensured.
Where device mounted socket-outlets are provided as part of the medical device, the
socket-outlets shall be on the same phase as the room socket-outlets. The supply to
these socket outlets shall be via the device on which they are mounted, so that they
do not remain live when the device is turned off.
Unenclosed flexible power cables shall be double insulated, and shall be provided
with effective strain relief. The unenclosed cables shall be of adequate length to
prevent strain arising with articulated systems or equipment movements.
The emergency off shall remove all power to equipment in the room.
The emergency stop is a safety feature of the medical device. Some parts of the
device may remain powered after the emergency stop has been activated. In some
instances, operating the emergency stop button will initiate a graceful shutdown, in
which data is saved before the equipment is shut down completely.
The number and location of emergence stop/emergency off buttons shall be agreed
between the equipment supplier and the purchaser.
An emergency stop/off switch shall be provided near to the control console and within
any partitioned area. In radiotherapy installations, the emergency stop switch shall
also be activated when the treatment room door switch (or the maze interlock) is
activated.
The controlled area warning light may be connected so that it is illuminated when the
X-ray, CT or radiotherapy unit is switched on. The switching arrangements, location,
height, and number of illuminated warning signs shall be agreed with the local
radiation protection advisor (RPA).
This is intended for static vehicle use and does not apply to ambulances.
Electrical services associated with the vehicle or container shall be installed, tested
and commissioned in accordance with all current legislation, standards, codes of
practice and guidelines.
The external mains supply source supplying the transportable room shall be TN-S,
terminated in a BS EN 60309 compliant switched socket-outlet, which shall be
housed in a suitable weather protective lockable enclosure (minimum IP44). The
mains impedance to the socket-outlet shall be measured, and the value recorded. A
label shall be fixed to the enclosure giving the mains impedance and current rating of
the supply. Any power consumption meters shall also be housed in an appropriate
enclosure.
The equipment supplier shall confirm that imaging equipment can operate correctly
on the impedance measured.
The transportable room supplier shall provide a double-insulated mains lead that is of
sufficient length, terminated with an impact resistant connector (minimum IP44). It is
permitted to fit a mains lead with connectors at each end to facilitate rapid mains lead
replacement as well as deployment and stowage. Alternatively, a cable storage drum
may be provided to facilitate cable withdrawal and retrieval into the storage
enclosure.
The supply lead and connector rating shall be of sufficient size to prevent significant
voltage-drop with instantaneous loads (e.g. X-ray exposure) along with other
The supply lead and connector will be supplying the domestic load, which will be
mainly air conditioning, heating, lighting and ancillary equipment, and the medical
device load.
Mains leads shall be routed to prevent entrapment from moving trailer parts such as
the fold-away trailer sides.
The mains lead and its connectors form part of the overall electrical system.
Changing the length and/or cross sectional area without the supplier’s agreement
could increase the impedance and thus prevent the medical devices from functioning
correctly.
A label shall be provided on the vehicle, adjacent to the cable socket, indicating the
maximum mains impedance that the vehicle can operate on, this value shall be
specified by the equipment supplier.
Where an electrical generator is provided it shall have a power rating that is sufficient
to serve all electrical loads, including peak demands, at the rated voltage and
frequency and within acceptable voltage waveform requirements.
Where both landline and onboard generator supplies are provided, the isolator shall
be interlocked to prevent both supplies being simultaneously connected. The isolator
shall also be able to isolate both supplies simultaneously.
The power supply to the transportable diagnostic or treatment room shall have an
RCD. The RCD shall have a blue label attached with large white font bearing the
inscription ‘Press the RCD TEST button every time the unit is connected’.
A low impedance earth from the mains supply or from the generator shall be
provided. Earth rods, i.e. metal rods inserted into the ground to connect a cable to
ground potential, shall not be used.
The continuity and quality of earth shall be tested at least whenever the transportable
room is moved to a new location.
9 Application of standards
If all such items are supplied by the manufacturer of the main medical device and are
intended by the manufacturer to be assembled into a system, the power and/or signal
connections shall be made in accordance with the manufacturer’s instructions.
In this case, the manufacturer is responsible for the safety of the assembled system.
Manufacturers can generally be expected to apply EN 60601-1-1 but are entitled to
achieve safety in other ways if they choose.
In all other cases the installer shall make the power and signal connections in
accordance with the requirements of BS EN 60601-1-1.
10.1 Background
This section refers to a data communication system that exchanges patient data and
images to and from the medical device. The manufacturer is responsible for any
issues inside supplied equipment that is CE marked to the Medical Device Directives.
Currently, IT equipment that is not a medical device, such as the Patient Record or
Radiology Information System (RIS), is not covered by any single regulatory body.
If the medical device is to be connected to a data network, the device installer shall
ensure that the network data connection point is in accordance with relevant
information provided by the device manufacturer, that the network data connection
point itself satisfies any requirements specified by the device manufacturer and
11.1 General
Results of the testing shall be available to the healthcare organisation responsible for
the equipment before the first use of the equipment/installation.
Every crimped termination that is part of the medical device electrical installation
(covered by this document) shall be inspected to ensure that it is terminated in a
manner that will ensure that the minimum resistance will be added to the circuit.
All cable ends should be crimp tagged using a compatible crimp tool. Where barrel
terminations are provided, bootlace terminations should be fitted.
Cable ends should not be folded back. Crimp tags should be of the correct size to
enable all conductors to be included in the crimp. The tags should be firmly tightened
on the appropriate terminating bolts, which shall be of brass or copper, and fixed via
tapped holes to the connecting bar with brass or copper nuts and washers. Bolts,
studs and tags should be of matching size. See sections 4.5 and 5.6.
Medical devices and associated circuits may be phase sensitive and confirmation of
the direction of phase rotation shall be ascertained as early as is possible.
The three-phase supply shall be tested for phase rotation, using a phase rotation
meter, at the mains supply terminals of the medical device on completion of the pre-
installation phase. The medical device Installer shall also complete this test.
If phase rotation is incorrect, the pre-installer shall take action to ensure the phase
rotation is correct by altering the cable connections at the load side of the Isolator.
Phase rotation should then be re-checked and the results recorded.
The mains supply voltage shall be checked. Any deficiencies of the mains supply
voltage shall be brought to the attention of the installer.
The mains supply impedance between each phase combination (L1-L2, L2-L3, L3-
L1) shall be measured and recorded. In the case of single-phase supplies, the
impedance from phase to neutral shall be measured. If the measured value is outside
of the range specified by the medical device manufacturer, action shall be taken to
bring the supply impedance into the specified range.
Test that all TN-S single-phase supplies in the diagnostic or treatment room or area
are connected to the same phase; this includes socket-outlets mounted on any
equipment. One socket-outlet in the room shall be deemed as a reference socket-
outlet for the purpose of this test.
The measurement of resistance alone does not prove compliance, because paths
additional to that deliberately provided through the network could exist and could
obscure the fact of inadequate conductivity in the qualifying path. Inspection of
design and construction is an essential step in the verification process.
The resistance shall be measured with an earth continuity tester, between each
protective earth terminal, socket-outlet or every accessible metal part and the ERB.
The maximum acceptable resistance in this test shall be 0.1 Ω. A minimum current of
1 A shall be used.
Testing of the socket-outlets can be achieved by using a meter lead connected to the
earth pin of a 13A plug to check the total resistance (including insertion resistance) of
the socket-outlet (the other meter lead shall be connected to the ERB). The
resistance value obtained using a standard earth pin may be different to that
obtained by inserting a test probe into the socket.
Touch voltages
The voltage between the ERB and every accessible conductive surface (referred to
as the touch voltage) at the patient location shall be measured using a high
impedance digital voltmeter:
Note: A person competent to operate an X-ray unit must be present in order to carry
out this part of the test.
The measured values shall not exceed 100 mV DC/AC 50 Hz. However, any voltage
greater than 10 mV DC/AC 50 Hz shall be investigated.
These values include the accessible metal parts of any socket-outlets such as the
mounting screws (not the socket-outlet contacts).
The aim of this test is to check whether any significant voltages exist between metal
parts in the patient environment and the ERB. The MHRA has evidence of insufficient
supplementary equipotential bonding for medical devices. In one example, the high
touch voltage was due to the room mains supply and the medical device supply
coming from two different sub-stations.
A TN-C-S system is one in which earth and neutral are common over part of the
system. In many cases this arises due to a fault in some other location. The effect of
this is to inject part of the load current into the earth system, which will result in
potential differences occurring between various earth points, this will vary depending
on the amount of current flowing at the time. This will give rise to a high touch
voltage.
The measurement of touch voltage and bonding resistance, together with visual
inspection of the electrical installation, shall take place before the magnetic field is
energised.
The inspection and testing of the installation shall be carried out by a suitably
appointed ‘Competent Person’.
This person shall be assessed and appointed in writing by the ‘Authorised Person
(LV)’ who shall verify that the proposed Competent Person possesses the necessary
technical knowledge, skills and experience relevant to the nature of the installation to
be tested.
Final pass
Pass Fail Failure description (use if all pass
first time)
BS7671 2001(2004)
Additional requirements of
IPS circuits if installed
Touch voltages
Phase rotation
Equipotential bonding
Cable crimps
Specific tests
Door warning lights on same
phase (e.g. X-ray/laser)
Name:
Job title:
Employer’s details:
BS7671 2001(2004):
Signature Date
Signature Date
Great Britain. Health and Safety at Work Act 1974. London: HMSO; 1974.
Guidance notes for NHS trusts on requirements for mobile trailers for breast
screening - 03043. MHRA; June 2003.
Guidance notes on electrical safety in rooms used for colposcopy and the safe use of
electrosurgery for LLETZ procedures. NHSCSP Equipment Report 0401 Dec 2004.
HTM 2007 Electrical services supply and distribution. NHS Estates; 1993.
Statutory Instrument 1999 No. 3232 The Ionising Radiation Regulations 1999. HMSO
1999.
Statutory Instrument 2002 No. 618 The Medical Devices Regulations 2002.
HMSO; 2002.
www.legislation.hmso.gov.uk/si/si2002/20020618.htm
Statutory Instrument 2002 No. 2665 The Electricity Safety, Quality and Continuity
Regulations 2002. HMSO; 2002.
Authorised Person
An individual possessing adequate technical knowledge and having received
appropriate training, appointed in writing by the authorising engineer to be
responsible for the practical implementation and operation of management’s safety
policy and procedures on defined electrical systems. (See HTM 2007).
Competent Person
An individual who in the opinion of an Authorised Person has sufficient technical
knowledge and experience to prevent danger while carrying out work on a defined
electrical system (see HTM 2007).
Contactor
A remotely operated single or three-phase electro-mechanical switch. See Figure 2.
Emergency off
The emergency off button will remove all power to the medical device. In some
circumstances removing power from a device may be hazardous.
Emergency stop
The emergency stop button is used to arrest the system to a safe condition as
defined by the manufacturer. The manufacturer is responsible for which functions of
the device are terminated.
ERB
See earth reference bar.
Installer
The person who installs, erects, or assembles, a permanently installed medical
device(s).
IP number (IP44)
The IP number indicates the degree of environmental protection of the device, and is
made up of two numbers. The first number (4) indicates that the device is protected
against solid objects with a diameter of down to 1 mm. If this number were 6, it would
indicate that the device was totally dust-proof.
The second number indicates the degree of protection against liquids. The number 4
indicates that it would be protected against a water spray from any direction. A
limited ingress of water is permitted. If this number were 8 it would be protected
against immersion in water for long periods.
Mains impedance
It is convenient to consider the mains voltage to have been supplied by a constant-
voltage source, and all the resistances and impedances to be lumped together. It will
include all of the wiring, connections, switch-gear, and transformers, back to, and
including the alternator. In practical terms this value will usually come to between 0.1
and 0.5 Ω total.
Mains supply
A single-phase 230 V AC or three-phase 400 V AC supply.
Medical device
Means any instrument, apparatus, appliance, material or any other article, whether
used alone or in combination including the software necessary for its proper
application intended by the manufacturer to be used for human beings for the
purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease. This
text is quoted verbatim from the Medical Device Directives.
Micro-shock
Micro-shock is the passage of a low level of electricity through the body, which
causes no perceptible sensation. The threshold of sensation is at about the 1 mA
level. The subject cannot detect currents below this level. These low-level events are
of no consequence unless the current passes through the cardiac conductive tissue,
in which case ventricular tachycardia or ventricular fibrillation may be triggered.
Currents of the order of 10 µA can be enough to initiate ventricular fibrillation.
Phase rotation
This document refers to the phase denotations of L1, L2 and L3 (L1 leads L2 and L2
leads L3).
Pre-installer
The person responsible for carrying out whatever mechanical or electrical work is
needed to prepare the location so that the installation of the defined medical
device(s) can take place.