Quantcast Lesson 4: Prepare and Process a Food and Drug Administration Form 2579 - Radiographic X-ray

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LESSON 4
PREPARE AND PROCESS A FOOD AND DRUG ADMINISTRATION
FORM 2579
Section I. PREPARATION
4-1.
GENERAL
Due to medical and legal implications relating to the exposure of humans to
ionizing radiation, accurate records are required to verify all assemblies, services,
adjustments, and calibrations of diagnostic X-ray equipment have been performed is
such a manner as to minimize patient exposure. Form Food and Drug Administration
(FDA) 2579 is the required record of the assembly and installation of certified diagnostic
X-ray systems. A blank Form FDA 2579 is shown in figure 4-1.
NOTE:
Forms printed prior to April 1989 are obsolete and are not to be
used.
4-2.
WHEN REQUIRED
a. A Form FDA 2579 must be prepared whenever a specified component of a
diagnostic X-ray system is installed in any Department of Defense (DOD) activity which
is certified to comply with the Standard. The Standard is 21, Code of Federal
Regulations (CFR), Part 1020, Standards for Protection Against Radiation.
b. A Form FDA 2579 must be prepared whenever any active or inactive military
member or civilian employee of the DOD, who, in the course of official duties, installs
certified X-ray equipment in any activity of the Federal or state governments of the
United States, regardless of the location.
c. A Form FDA 2579 must be prepared if the manufacturer's labeling contains a
statement such as "This component is certified to comply with the Standard in effect at
the date of manufacture," and the date of manufacture was 1 August 1974 or thereafter.
d. A Form FDA 2579 is also required when the installation or assembly of X-ray
diagnostic equipment is performed as an off-duty activity of DOD personnel who are
engaged in authorized self employment or are employed by another individual or
corporation.
4-3.
WHEN NOT REQUIRED
The Form FDA 2579 is not required when the X-ray system components are
temporarily installed as "loaners."
MD0351
4-2



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