Section 180-7-067 - USE OF A SEALED SOURCE IN A REMOTE AFTERLOADER UNIT, TELETHERAPY UNIT, OR GAMMA STEREOTACTIC RADIOSURGERY UNIT067.01APPROVED SEALED SOURCE. A licensee must only use sealed sources:(A) As approved and as provided for in the NRC Sealed Source and Device Registry; or(B) In research according to an active Investigational Device Exemption application accepted by the FDA provided the requirements of 180 NAC 7-021, (A) are met.067.02APPROVED DEVICES. A licensee must only use devices: (A) 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 according to radiation safety conditions and limitations described in the Sealed Source and Device Registry; or(B) In research according to an active Investigational Device Exemption application accepted by the FDA provided the requirements of 180 NAC 7-021, (A) are met.180 Neb. Admin. Code, ch. 7, § 067
Amended effective 11/3/2020Amended effective 6/14/2023