12 Va. Admin. Code § 5-481-1653 - Hand-held radiographic unit
In addition to the applicable provisions found elsewhere
in this chapter, the following provisions apply to a
1. A hand-held radiograph unit
shall be:
a. Certified by the manufacturer
pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and
Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V,
Part C - Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of
the Federal Food, Drug and Cosmetic Act ; and
21 CFR
1020.30, Diagnostic x-ray systems and their
major components.
b. Registered
with the agency in accordance with applicable parts of this chapter.
c. Maintained and operated in accordance with
the manufacturer's specifications.
2. For all uses:
a. Operators of a hand-held radiographic unit
shall be specifically trained to operate such equipment.
b. When operating a hand-held radiographic
unit , operators shall wear dosimetry unless otherwise authorized by the
agency .
c. A hand-held radiographic
unit shall have the backscatter radiation shield in place to protect the
operator during operation.
d. The
operator shall ensure there are no bystanders within a radius of at least six
feet from the patient being examined with a hand-held radiograph
unit.
e. A hand-held radiographic
unit shall not be used in hallways or waiting rooms.
Notes
Statutory Authority: § 32.1-229 of the Code of Virginia.
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