South Australian Consolidated Regulations South Australian Consolidated Regulations99—Apparatus used for mammography or soft tissue radiography
(1) Apparatus that is
used for mammography or soft tissue radiography must—
(a) if
the apparatus had been registered under the revoked Health Act
regulations—comply with—
(i)
the requirements of subregulations (2) to (6)(a), (7),
(8) and (11); and
(ii)
the requirements of either subregulations (9)(a) and (10)
or subregulation (9)(b);
(b) in
any other case—comply with the requirements of subregulations (2) to
(16).
(2) A device or stand
designed to hold the image receptor must have a protective backing with a lead
equivalent of at least 0.25mm.
(3) If X-ray tube
potential, current or exposure time—
(a) are
capable of being varied—control settings must be provided on the control
panel so that the required value of tube potential, current and exposure time
or a combination of these can be set without a trial exposure being made; or
(b) are
not capable of being varied—the values of that potential, current or
exposure time must be indicated on the control panel.
(4) The half value
layer of the primary beam must, for every available kilovoltage, be not less
than the value of half value layer shown in the table set out in Schedule 7 as
being appropriate to the selected kilovoltage.
(5) The apparatus must
be fitted with a device that will terminate the exposure after a preset—
(a) time
interval; or
(b)
product of tube current and time; or
(c)
programmed exposure.
(6) The exposure
switch fitted to the apparatus must—
(a) have
a circuit closing contact that—
(i)
can be maintained only by continuous pressure; and
(ii)
makes it impossible to make repeat exposures without
releasing the switch; and
(iii)
in the case of programmed exposures—makes it
possible to interrupt the exposure at any stage of the programme; and
(b) not
be operable in parallel with any other exposure switch.
(7) The X-ray tube
housing must be supported so that it remains stationary when placed in
position for radiography.
(8) The apparatus must
produce a consistent linear radiation output so that—
(a) the
coefficient of variation of at least five measurements of radiation output
taken at the same exposure settings must be less than or equal to 0.05; and
(b) the
coefficient of variation of at least five values of the ratio of radiation
output to charge, where the radiation output is measured at a fixed
kilovoltage and the charge is that indicated on the control panel and is
varied from measurement to measurement, must be less than or equal to 0.1.
(9) The apparatus must
incorporate a device that provides a warning to the operator whenever the tube
is energised, being a warning that consists of—
(a) a
clearly distinguishable red or amber light; and
(b) an
audible signal that is audible at the location from which the equipment is
operated and indicates either the duration or termination of the exposure.
(10) If the apparatus
does not have the audible signal referred to in subregulation (10) it must not
have an indicator light on the control panel that is the same colour as the
light referred to in that subregulation.
(11) The apparatus
must have a readily accessible mains switch to control the supply of mains
power to the apparatus and a mains indicator light to indicate when the
control panel is energised and the mains switch is in the "ON" position.
(12) The X-ray
field—
(a) must
extend to the edge of the patient support that is designed to be adjacent to
the chest wall of the patient and must not extend beyond that edge by more
than 5mm; and
(b) must
not extend beyond any edges of the image receptor by a distance greater than
2% of the focal spot to image receptor distance.
(13) The X-ray tube
must be enclosed in a housing so that the equivalent dose rate from leakage
radiation, measured at a distance of 1 metre from the focus of that tube over
a detection area not larger than 10 000mm 2 , does not exceed 1
millisievert in 1 hour at each rating specified by the manufacturer for that
tube in that housing.
(14) If more than one
X-ray tube can be operated from a single control panel, except in the case of
diagnostic X-ray apparatus specifically designed for two tube techniques, it
must not be possible to energise more than one X-ray tube at the same time and
there must be an indication—
(a) on
the control panel; and
(b) at
or near the tube housing,
showing which X-ray tube is selected.
(15) If an apparatus
is fitted with an automatic exposure control—
(a) the
selection of the control must, when it takes place, be clearly indicated on
the control panel; and
(i)
the exposure time to no more than six seconds; or
(ii)
the product of the tube current selected and exposure
time delivered to no more than 600 milli-ampere seconds; and
(c)
where an exposure has been terminated after the period referred to in
paragraph (b)—a visible or audible signal must indicate that
termination has occurred and manual resetting of the control must then be
required before further automatically timed exposures can be made.
(16) The position of
the focal spot must be clearly indicated on the tube housing.