Illinois Administrative Code
Title 32 - ENERGY
Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL
Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 335.8010 - Use of a Sealed Source in Remote Afterloader Units, Teletherapy Units or Gamma Stereotactic Radiosurgery Units
Universal Citation: 32 IL Admin Code ยง 335.8010
Current through Register Vol. 48, No. 52, December 27, 2024
a) A licensee shall only use sealed sources:
1) Obtained from a person specified in
Section 335.35, or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements; or
2) 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
3) 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 Section 335.35 are met.
b) A licensee shall use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:
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
2) In research in accordance with an active
Investigational Device Exemption (IDE) application accepted by the U.S. Food
and Drug Administration provided the requirements of Section 335.35 are
met.
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