South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-63 - Radioactive Materials (Title A)
Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS
Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 61-63.IV.H.RHA 4.58 - Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit
Universal Citation: SC Code Regs 61-63.IV.H.RHA 4.58
Current through Register Vol. 48, No. 9, September 27, 2024
4.58.1 A licensee must only use sealed sources:
4.58.1.1 Approved and as
provided for in the Sealed Source and Device Registry in photon emitting remote
afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to
deliver therapeutic doses for medical uses: or
4.58.1.2 In research involving photon-emitting
remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
units in accordance with an active Investigational Device Exemption (IDE)
application accepted by the U.S. Food and Drug Administration provided the
requirements of RHA 4.19.1 are met.
4.58.2 A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:
4.58.2.1 Approved in the Sealed Source and Device
Registry to deliver a therapeutic dose for medical use. These devices may be used
for therapeutic medical treatments that are not explicitly provided for in the
Sealed Source and Device Registry, but must be used in accordance with radiation
safety conditions and limitations described in the Sealed Source and Device
Registry; or
4.58.2.2 In research in
accordance with an active Investigational Device Exemption (IDE) application
accepted by the FDA provided the requirements of RHA 4.19.1 are
met.
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