N.H. Admin. Code § He-P 4032.07

Current through Register No. 45, November 7, 2024

Section He-P 4032.07 - Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use

(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to He-P 4035 for use as a calibration, transmission, or reference source, or sources for the uses in manual brachytherapy, or sealed sources for diagnosis, or sealed source for the use in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit in accordance with He-P 4035 shall be approved if:

(1) The applicant satisfies the general requirements in He-P 4030.09;

(2) The applicant submits the following radiation safety information for each type of source or device:

a. The byproduct material contained, its chemical and physical form, and amount;

b. Details of design and construction of the source or device;

c. Procedures for, and results of, prototype tests to demonstrate that the source or device maintains its integrity under stresses likely to be encountered in normal use and accidents;

d. For devices containing byproduct material, the radiation profile of a prototype device;

e. Details of quality control procedures to ensure that production sources and devices meet the standards of the design and prototype tests;

f. Procedures and standards for calibrating sources and devices;

g. Legend and methods for labeling sources and devices for their radioactive content; and

h. Instruction for handling and storing the source or device from the radiation safety standpoint, as follows:

1. These instructions shall be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; or

2. If the instructions are too lengthy for such label, they may be summarized on the label and printed in detail on a brochure which is referenced on the label;

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains the following information:

a. The radionuclide;

b. Quantity;

c. Date of assay; and

d. A statement that includes the name of source or device which is licensed by DHHS/RHS for distribution to persons licensed pursuant to He-P 4035 or under equivalent licenses of the Nuclear Regulatory Commission, an agreement state, or licensing state; and

(4) The source or device has been registered in the Sealed Source and Device Registry.

(b) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months:

(1) The application shall include sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and

(2) In determining the acceptable interval for test of leakage of radioactive material, DHHS/RHS will consider information that includes, but is not limited to:

a. Primary containment (source capsule) ;

b. Protection of primary containment;

c. Method of sealing containment;

d. Containment construction materials;

e. Form of contained radioactive material;

f. Maximum temperature withstood during prototype tests;

g. Maximum pressure withstood during prototype tests;

h. Maximum quantity of contained radioactive material;

i. Radiotoxicity of contained radioactive material; and

j. Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

N.H. Admin. Code § He-P 4032.07

(See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07

Amended by Volume XXXV Number 49, Filed December 10, 2015, Proposed by #10983, Effective 11/24/2015, Expires11/24/2025.