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Electronic Code of Federal Regulations

e-CFR data is current as of June 2, 2020

Title 10Chapter IPart 35Subpart H → §35.657


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart H—Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units


§35.657   Therapy-related computer systems.

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(a) The source-specific input parameters required by the dose calculation algorithm;

(b) The accuracy of dose, dwell time, and treatment time calculations at representative points;

(c) The accuracy of isodose plots and graphic displays;

(d) The accuracy of the software used to determine sealed source positions from radiographic images; and

(e) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

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