Washington Administrative Code
Title 246 - Health, Department of
RADIATION
Chapter 246-240 - Radiation protection Medical use of radioactive material
PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 246-240-351 - Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit

(a) 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

(b) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active IDE application accepted by the FDA provided the requirements of WAC 246-240-066(1) are met.

(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 in accordance with radiation safety conditions and limitations described in the sealed source and device registry; or

(b) In research in accordance with an active IDE application accepted by the FDA provided the requirements of WAC 246-240-066(1) are met.