| (103) Traceable to a national standard--This indicates
that a quantity or a measurement has been compared to a national standard,
for example, the National Institute of Standards and Technology, directly
or indirectly through one or more intermediate steps and that all
comparisons have been documented.
(104) Tube--An x-ray tube, unless otherwise specified.
(105) Tube housing assembly--The tube housing with
tube installed. It includes high-voltage and/or filament transformers
and other appropriate elements when such are contained within the
tube housing.
(106) Useful beam--Radiation that passes through the
window, aperture, cone, or other collimating device of the source
housing. Also referred to as the primary beam.
(107) X-ray control panel--A device that controls input
power to the x-ray high-voltage generator and/or the x-ray tube. It
includes equipment such as timers, phototimers, automatic brightness
stabilizers, and similar devices that control the technique factors
of an x-ray exposure.
(108) X-ray field--That area of the intersection of
the useful beam and any one of the set of planes parallel to and including
the plane of the image receptor, whose perimeter is the locus of points
at which the exposure rate (air kerma rate) is 1/4th of the maximum
in the intersection.
(109) X-ray high-voltage generator--A device that transforms
electrical energy from the potential supplied by the x-ray control
to the tube operating potential. The device may also include means
for transforming alternating current to direct current, filament transformers
for the x-ray tubes, high-voltage switches, electrical protective
devices, and other appropriate elements.
(110) X-ray system--An assemblage of components for
the controlled production of x-rays and include a radiation machine.
It includes minimally an x-ray high-voltage generator, an x-ray control,
a tube housing assembly, a beam-limiting device, and the necessary
supporting structures. Additional components that function with the
system are considered integral parts of the system.
(111) X-ray tube--Any electron tube that is designed
to be used primarily for the production of x rays.
(f) Morgues, forensic medicine, and educational facilities.
(1) Morgues shall comply with the following requirements:
(A) subsection (b)(1) and (2) of this section concerning
scope;
(B) subsection (c) of this section concerning prohibitions;
(C) subsection (e) of this section concerning definitions,
as applicable;
(D) subsection (i)(2) of this section concerning operating
and safety procedures;
(E) subsection (i)(4) of this section concerning protective
devices;
(F) subsection (i)(11) of this section concerning holding
of tube;
(G) subsection (k)(1) of this section concerning warning
labels;
(H) subsection (m)(1)(A) of this section concerning
fluoroscopy; and
(I) subsection (s)(1)(A) - (I), and (R) of this section
concerning records.
(2) Facilities conducting training using non-humans
shall comply with all the requirements of this section except for
the following:
(A) subsection (i)(5) of this section concerning operator
credentialing;
(B) subsection (j) of this section concerning radiographic
entrance exposure (air kerma) limits;
(C) subsections (p), (q) and (r) of this section concerning
film processing; and
(D) subsection (o) of this section concerning equipment
performance evaluation.
(g) Requirements for bone densitometers. Bone densitometers
shall be exempt from this chapter except for the following:
(1) §289.203 of this title, §289.204 of this
title, §289.205 of this title, §289.226 of this title, and §289.231
of this title;
(2) healing arts screening and medical research in
accordance with §289.226(h) and (t) of this title;
(3) purpose and scope in accordance with subsections
(a) and (b) of this section;
(4) prohibitions in accordance with subsection (c)(1)
and (2) of this section;
(5) definitions in accordance with subsection (e) of
this section, as applicable;
(6) operating and safety procedures in accordance with
subsection (i)(2) of this section;
(7) operator training in accordance with §140.521
of this title (relating to Bone Densitometry Training);
(8) gonadal shielding in accordance with subsection
(i)(13) of this section;
(9) warning labels in accordance with §289.231(z)
of this title.
(10) record requirements for authorized use locations
and authorized records locations for mobile services in accordance
with subsection (s)(1)(A) - (D), (G), (J), (R), and (s)(2) of this
section; and
(11) record requirements for mobile services in accordance
with subsection (s)(1)(A), (D), (H), and (J) of this section. These
records shall be maintained with the bone densitometer authorized
to be used for mobile services.
(h) Certified x-ray systems. In addition to the requirements
of this chapter, the registrant shall not make, nor cause to be made,
any modification of components or installations of components certified
in accordance with the United States Food and Drug Administration
(FDA) Title 21, CFR, Part 1020, "Performance Standards for Ionizing
Radiation Emitting Products," as amended, in any manner that could
cause the installations or the components to fail to meet the requirements
of the applicable parts of the standards specified in Title 21, CFR,
Part 1020, except where a variance has been granted by the Director,
Center for Devices and Radiological Health, FDA. A copy of the variance
shall be maintained by the registrant in accordance with subsection
(s)(1) of this section for inspection by the agency.
(i) General operating requirements.
(1) Technique chart. A technique chart relevant to
the particular radiation machine shall be provided or electronically
displayed in the vicinity of the control panel and used by all operators.
(2) Operating and safety procedures.
(A) Each registrant shall have and implement written
operating and safety procedures. The procedures shall include, but
are not limited to, the following as applicable:
(i) posting notices to workers in accordance with §289.203(b)
of this title;
(ii) instructions to workers in accordance with §289.203(c)
of this title;
(iii) notifications and reports to individuals in accordance
with §289.203(d) of this title;
(iv) ordering x-ray exams in accordance with §289.231(b)(1)
of this title;
(v) occupational dose requirements in accordance with §289.231(m)
of this title;
(vi) personnel monitoring requirements in accordance
with §289.231(n), (q), and (s) of this title;
(vii) posting of a radiation area in accordance with §289.231(x)
of this title;
(viii) use of a technique chart in accordance with
paragraph (1) of this subsection;
(ix) use of protective devices in accordance with paragraph
(4) of this subsection;
(x) credentialing requirements for individuals operating
radiation machines in accordance with paragraph (5) of this subsection;
(xi) exposure of individuals other than the patient
in accordance with paragraph (7) of this subsection;
(xii) holding of patients or image receptors in accordance
with the following;
(I) a list of circumstances in which mechanical holding
devices cannot be routinely utilized; and
(II) a procedure used for selecting an individual to
hold or support the patient or image receptor.
(xiii) gonadal shielding in accordance with paragraph
(13) of this subsection;
(xiv) control of scattered radiation in accordance
with subsection (m)(8) of this section; and
(xv) film processing program or digital image processing
protocols in accordance with subsections (p), (q), and (r) of this
section.
(B) The registrant shall maintain the operating and
safety procedures in accordance with subsection (s)(1) of this section
for inspection by the agency.
(C) The procedures shall be made available to each
individual operating a radiation machine, including any restrictions
of the operating technique required for the safe operation of the
particular x-ray system.
Cont'd... |
