New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 4000 - NEW HAMPSHIRE RULES FOR THE CONTROL OF RADIATION
Part He-P 4047 - USE OF RADIATION MACHINES: THERAPEUTIC RADIATION MACHINES
Section He-P 4047.12 - Other Use of Electronically-Produced Radiation to Deliver Therapeutic Radiation Dosage
Universal Citation: NH Admin Rules He-P 4047.12
Current through Register No. 40, October 3, 2024
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.
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