Section He-P 4047.12 - Other Use of Electronically-Produced Radiation to Deliver Therapeutic Radiation Dosage A person shall not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not appropriately regulated under any existing category of therapeutic radiation machine, until:
(a) The applicant or registrant has, at a minimum, provided DHHS/RHS with: (1) A detailed description of the device and its intended application(s):(2) Facility design requirements, including shielding and access control;(3) Documentation of appropriate training for authorized user physician(s) and radiation therapy physicist(s);(4) Methodology for measurement of dosages to be administered to patients or human research subjects;(5) Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety;(6) Radiation safety precautions and instructions; and(7) Other information requested by DHHS/RHS in its review of the application.(b) The applicant or registrant has received approval from DHHS/RHS to utilize the device in accordance with the regulations and specific conditions DHHS/RHS considers necessary for the medical use of the device.N.H. Admin. Code § He-P 4047.12
Derived From Volume XXXV Number 32, Filed August 13, 2015, Proposed by #10894, Effective 7/21/2015, Expires 7/21/2025.