DHS 157.13(4)(j)(j) Manufacture and distribution of sources or devices containing radioactive material for medical use. The department shall approve an application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed under subch. VI for use as a calibration, transmission or reference source or for the uses listed in ss. DHS 157.65 (1), 157.66 (1), 157.67 (1) and 157.70 if all of the following conditions are satisfied:
DHS 157.13(4)(j)1.1. The applicant satisfies the general requirements in sub. (2).
DHS 157.13(4)(j)2.2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including all of the following:
DHS 157.13(4)(j)2.a.a. The radioactive material contained, its chemical and physical form and amount.
DHS 157.13(4)(j)2.b.b. Details of design and construction of the source or device.
DHS 157.13(4)(j)2.c.c. Procedures for and results of prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents.
DHS 157.13(4)(j)2.d.d. For devices containing radioactive material, the radiation profile of a prototype device.
DHS 157.13(4)(j)2.e.e. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests.
DHS 157.13(4)(j)2.f.f. Procedures and standards for calibrating sources and devices.
DHS 157.13(4)(j)2.g.g. Legend and methods for labeling the radioactive content of sources and devices.
DHS 157.13(4)(j)2.h.h. Instructions for handling and storing the source or device from the radiation safety standpoint. The 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; provided, that instructions that are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label.
DHS 157.13(4)(j)3.3. The label affixed to the source or device or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the department for distribution to persons licensed under subch. VI and s. DHS 157.62 (4) or under equivalent licenses of the NRC, an agreement state or a licensing state.
DHS 157.13(4)(j)4.4. If the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months, the applicant shall include in the application 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. In determining the acceptable interval for the test for leakage of radioactive material, the applicant shall submit all of the following information:
DHS 157.13(4)(j)4.a.a. Primary containment of the source capsule.
DHS 157.13(4)(j)4.b.b. Protection of primary containment.
DHS 157.13(4)(j)4.c.c. Method of sealing containment.
DHS 157.13(4)(j)4.d.d. Containment construction materials.
DHS 157.13(4)(j)4.e.e. Form of contained radioactive material.
DHS 157.13(4)(j)4.f.f. Maximum temperature withstood during prototype tests.
DHS 157.13(4)(j)4.g.g. Maximum pressure withstood during prototype tests.
DHS 157.13(4)(j)4.h.h. Maximum quantity of contained radioactive material.
DHS 157.13(4)(j)4.i.i. Radiotoxicity of contained radioactive material.
DHS 157.13(4)(j)4.j.j. Operating experience with identical sources or devices or similarly designed and constructed sources or devices.
DHS 157.13(4)(j)5.5. The source or device has been registered in the sealed source and device registry.
DHS 157.13(4)(k)(k) Requirements for license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications.
DHS 157.13(4)(k)1.1. The department shall approve an application for a specific license to manufacture industrial products and devices containing depleted uranium for use under s. DHS 157.11 (1) (c) or equivalent regulations of the NRC or an agreement state under the following conditions:
DHS 157.13(4)(k)1.a.a. The applicant satisfies the general requirements specified in sub. (2).
DHS 157.13(4)(k)1.b.b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to provide reasonable assurance that possession, use or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one year a radiation dose in excess of 10% of the annual limits specified in s. DHS 157.22 (1).
DHS 157.13(4)(k)1.c.c. The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.