10 CFR 32.210

Sealed Source and Device Registration ===§ 32.210 Registration of product information.===

a

(a) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the NRC for evaluation of radiation safety information about its product and for its registration.

b

(b) The request for review must be sent to the NRC's Office of Federal and State Materials and Environmental Management Programs, ATTN: SSDR by an appropriate method listed in § 30.6(a) of this chapter.

c

(c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

d

(d) The NRC normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the NRC formulates reasonable standards and criteria with the help of the manufacturer or distributor. The NRC shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Subpart A of this part includes specific criteria that apply to certain exempt products and subpart B includes specific criteria applicable to certain generally licensed devices. Subpart C includes specific provisions that apply to certain specifically licensed items.

e

(e) After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

f

(f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with-

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the registration certificate.

g

(g) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(1) Calibration and reference sources containing no more than:

(i) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or

(ii) 0.37 MBq (10 μCi), for alpha emitting radionuclides; or

(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(i) The intended recipients are licensed under part 33 of this chapter or comparable provisions of an Agreement State; or

(ii) The recipients are authorized for research and development; or

(iii) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.

h

(h) After the certificate is issued, the Commission may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Commission will complete its evaluation in accordance with criteria specified in this section. The Commission may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested.

Federal Register

, as amended at 60 FR 24551, May 9, 1995; 68 FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 31, 2008; 77 FR 43695, Jul. 25, 2012]

External Links

NRC website 10 CFR 32.210

v t e Code of Federal Regulations
Title 10 Part 32 - PART 32-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
10 CFR: 1 2 4 5 7 9 10 11 12 13 14 15 16 19 20 21 25 26 30 31 32 33 34 35 36 37 39 40 50 51 52 54 55 60 61 62 63 70 71 72 73 74 75 76 81 95 100 140 150 160 170 171
1, Purpose and scope 2, Definitions 3, Maintenance of records 8, Information collection requirements: OMB approval 11, Exempt Concentrations and Items 12, Same: Records and material transfer reports 13, Same: Prohibition of introduction 14, Certain items containing byproduct material; requirements for license to apply or initially transfer 15, Same: Quality assurance, prohibition of transfer, and labeling 16, Certain items containing byproduct material: Records and reports of transfer 17, 18, Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license 19, Same: Conditions of licenses 20, Same: Records and material transfer reports 21, Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for "in vivo" diagnostic use for humans to persons exempt from licensing; Requirements for a license 22, Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer 23, Same: Safety criteria 24, Same: Table of organ doses 25, Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer 26, Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer 27, Same: Safety criteria 28, Same: Table of organ doses 29, Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer 30, Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer 31, Certain industrial devices containing byproduct material: Safety criteria 32, Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer 40, 51, Generally Licensed Items 52, Same: Material transfer reports and records 53, Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer 54, Same: Labeling of devices 55, Same: Quality assurance; prohibition of transfer 56, Same: Material transfer reports 57, Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer 58, Same: Labeling of devices 59, Same: Leak testing of each source 60, 61, Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer 62, Same: Quality assurance; prohibition of transfer 71, Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license 72, Specifically Licensed Items 74, Manufacture and distribution of sources or devices containing byproduct material for medical use 201, Serialization of nationally tracked sources 210, Sealed Source and Device Registration 211, 301, Violations 303, Criminal penalties Appendices:

10 CFR 32.210

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10 CFR 32.210

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h

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