Current through Register Vol. 48, No. 9, September 27, 2024
7.5.1 Safety Device. A device which prevents
the entry of any portion of an individual's body into the primary beam path, or
which causes the beam to be shut off upon entry into its path, shall be
provided on all open-beam configuration x-ray equipment. A registrant may apply
to the Department for an exemption from the requirement of a safety device.
Such application shall include:
7.5.1.1 A
description of the various safety devices that have been evaluated;
7.5.1.2 The reason each of these devices
cannot be used;
7.5.1.3 A
description of the alternative methods that will be employed to minimize the
possibility of an accidental exposure, including procedures to assure that
operators and others in the area will be informed of the absence of the safety
devices; and
7.5.1.4 The procedure
for notifying proper persons in the event of an accident. This list shall
include the names, addresses, and telephone numbers.
7.5.2 The operator shall be in immediate
attendance at all times when the equipment is in operation except when the area
is locked to protect against unauthorized or accidental entry.
7.5.3 When not in use, equipment shall be
secured in such a manner as to be inoperable by unauthorized persons.
7.5.4 Warning Devices. Open-beam
configuration x-ray equipment shall be provided with a readily discernible
indication of:
7.5.4.1 X-ray tube status
(ON-OFF) located near the radiation source housing, if the primary beam is
controlled in this manner, or
7.5.4.2 Shutter status (OPEN-CLOSED) located
near each port on the radiation source housing, if the primary beam is
controlled in this manner.
7.5.5 Warning devices shall be labeled so
that their purpose is easily identified.
7.5.6 Warning devices shall have fail-safe
characteristics.
7.5.6.1 Where couplings exist
(e.g., between the x-ray tube and the collimator of the diffractometer, etc.),
they shall prevent radiation from escaping the coupling.
7.5.6.2 Each port of the radiation source
housing shall be provided with a beam shutter interlocked with the x-ray
apparatus coupling, or collimator, in such a way that the port will be open
only when the collimator or coupling is in place.
7.5.7 Operating Procedures. The registrant
shall create and make available to x-ray operators written operating
procedures. The procedures shall include, but not be limited to:
7.5.7.1 Policies and procedures for personnel
monitoring;
7.5.7.2 Policies and
procedures for controlling access to radiation areas;
7.5.7.3 Policies and procedures for locking
and securing the x-ray unit;
7.5.7.4 Policies and procedures for pregnant
employees; and
7.5.7.5 Policies and
procedures for training new employees.
7.5.8 Operator training.
7.5.8.1 No person shall be permitted to
operate, repair, modify, or maintain open-beam configuration analytical x-ray
equipment unless such person has received instruction in and demonstrated
competence in:
7.5.8.1.1 Identification of
radiation hazards associated with the use of the equipment;
7.5.8.1.2 Significance of the various
radiation warning and safety devices incorporated into the equipment or the
reasons they have not been installed on certain pieces of equipment and the
extra precautions required in such cases;
7.5.8.1.3 Proper operation of the equipment
per manufacturer's guidelines and registrant's written operating
procedures;
7.5.8.1.4 Radiation
survey instruments: operation, calibration, limitations, and survey techniques,
if applicable;
7.5.8.1.5
Characteristics of ionizing radiation;
7.5.8.1.6 Methods of controlling radiation
dose;
7.5.8.1.7 Units of radiation
dose;
7.5.8.1.8 Personnel
monitoring and the use of personnel monitoring equipment;
7.5.8.1.9 Symptoms of an acute localized
exposure;
7.5.8.1.10 Proper
procedures for reporting an actual or suspected overexposure; and
7.5.8.1.11 The regulations contained in this
Part, and the applicable sections of Part III.
7.5.8.2 Instruction and demonstration of
competence shall be documented in writing and these records shall be available
for review.