7.18.2 - Recommendations
for medical locations
Patient safety
Since the hazard to people will depend on the treatment
being administered, hospital locations are divided into
groups as follows:
1. - Group Zero: where no treatment
or diagnosis using medical electrical equipment is administered,
e.g. consulting rooms;
2. - Group One: where medical electrical
equipment is in use, but not for treatment of heart (intracardiac)
conditions;
3. - Group Two: where medical electrical
equipment is in use for heart (intracardiac) conditions.
TN-C systems (where earth and neutral are
combined - see
{5.2.5}) is not allowed in medical locations because
load currents in PEN conductors and parallel paths can cause
electromagnetic interference to medical equipment. Protection
against direct contact must be by insulation of live parts
and by barriers or enclosures. SELV and PELV systems (see
{3.4.4}) may be used in Group One and in Group Two locations,
but is limited to 25 V r.m.s. a.c. or 60 V ripple free d.c.
Even at these voltages, protection of live parts by insulation
or by barriers or enclosures is essential. Exposed conductive
parts of PELV systems must be connected to the local equipotential bonding conductor. FELV Systems (see
{3.4.4}) may be used in Group Zero locations only.
Protection against indirect contact may
be by automatic disconnection of the supply (see
{3.4.6}), by electrical separation (see
{5.8.4}), or by the use of Class II equipment (see
{5.8.4}) except as indicated below:
For TN Systems
(see {5.2.3} and {5.2.4})
any medical equipment in Group One or in Group Two locations
which is situated within 2.5 m above the floor or within
1.5 m horizontally from the edge of the bed, operating table,
etc., on which the patient is lying, called the patient
environment (see {Fig 7.27}), must be RCD protected, the
rating of the device being 30 mA or less if the circuit
protection does not exceed 32 A, or 300 mA or less if the
circuit protection exceeds 32 A. Note, however, that in
Group Two locations, RCDs may only be used for X-ray units
or for equipment with a rated power greater than 5 kvA,
Fig 7.27 - The patient
environment
For IT systems (see
{5.2.2}) used
in Group One and Group Two situations, the same requirements
apply as in TN systems with earth fault protection provided
by RCDs.
For IT Systems (see
{5.2.6)) it is recommended that an IT system is used
for circuits supplying medical equipment that is intended
to be used for life-support of patients. This is because
the total absence of an earthing system makes indirect contact
an impossibility. Any medical equipment in Group Two which
is situated in the patient environment (see {Fig 7.27})
must have a safety isolating transformer incorporated into
its IT system, and must have an insulation monitoring device.
This device must have:
1. - acoustic and visual alarms
that are triggered at the first earth fault, and
2. - an a.c. internal resistance
of at least 100 kOhms, and
3. - a test voltage not exceeding
25 V, and
4. - a test current not exceeding
1 mA even under fault conditions, and
5. - activation when the insulation
resistance falls to less than 50 kOhms, and
6. - activation when any wiring
or earth is disconnected.
If a socket outlet on a patient bedhead
location in a Group Two situation is supplied from an IT
system, it must be fed from at least two separate circuits.
Socket outlets in a Group Two situation fed from other systems
(TN-S or TT) must be clearly marked to distinguish
them from IT system socket outlets. Any wiring system within
a Group Two location must supply only the equipment and
fittings in that group (see {Fig 7.28}.
Fig 7.28 Distribution
network with insulation monitoring
Supplementary equipotential bonding
This bonding is required within Groups One and Two
locations, the resistance of the bonding conductors not
exceeding 0.2 Ohms. In Group Two locations circuits supplying
electrical equipment situated within the patient environment
(see {Fig 7.27}), the voltage between extraneous conductive
parts and the protective conductor system must never exceed
20 mV, even under fault conditions. This figure is based
on the leakage current through the patient never exceeding
50 mA. Assuming a body impedance of 1 kOhm, this gives a
maximum voltage of 50 mV, 30 mV of which is assumed to be
the volt drop from the socket outlet to the equipment.
Explosion risk
The gases used as anaesthetics in operating theatres
are flammable if present in high concentrations. Provided
that there is adequate ventilation (20 air changes per hour)
no special precautions are necessary for the electrical
installation.
Standby power supplies
The failure of the power supply may well have fatal
consequences, for example if the lighting fails in an operating
theatre, or the feed to a life support system is lost in
an intensive care unit. Safety power supplies are split
into three categories depending on how quickly the supply
is restored after failure. The time periods are 0.5 s, which
applies to operating theatre lighting and where the standby
system will be an uninterruptible power supply unit (UPS),
15 s for most essential hospital supplies, where a standby
generator is likely, and more than 15 s, which is likely
to apply to offices, staff accommodation and so on. Emergency
lighting fed from a safety source is required at escape
routes, exit signs and locations of essential services in
Groups One and Two locations.
Department of Health recommendations
The Department provides guidance through its Health
Technical Memoranda (HTM) series of publications. These
extremely detailed volumes are available from HMSO bookshops.