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 4035 - USE OF RADIONUCLIDES IN THE HEALING ARTS
Section He-P 4035.47 - Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit

Universal Citation: NH Admin Rules He-P 4035.47

Current through Register No. 40, October 3, 2024

A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

(a) As approved in the Sealed Source and Device Registry to deliver therapeutic doses for medical uses, or in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of He-P 4035.15(a) are met; or

(b) Approved in the Sealed Source Device Registry to deliver a therapeutic dose for medical use. These devices may be used for:

(1) Therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but shall 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 FDA provided the requirements of He-P 4035.15(a) are met.

(See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07

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