Sealed Sources and Devices Toolkit

This toolkit is designed to help licensees find key information easily.

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Regulations

The NRC's regulations are found in Chapter I of Title 10, "Energy," of the Code of Federal Regulations (CFR). Chapter I is divided into Parts 1 through 199. The following parts contain the requirements most relevant to sealed sources and devices:

  • Part 21 - Reporting of defects and noncompliance
  • Part 30.19 - Self-luminous products containing tritium, krypton-85, or promethium-147
  • Part 30.20 - Gas and aerosol detectors containing byproduct material
  • Part 31.5 - Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere (devices used under the general license in Part 31.5)
  • Part 31.7 - Luminous safety devices for use in aircraft
  • Part 31.10 - General license for strontium-90 in ice detection devices
  • Parts 34.20, 34.21, 34.27 - Radiography equipment
  • Parts 39.31(a), 39.35, 39.41 - Well-logging equipment
  • Parts 36.21(a), 36.59 - Irradiators
  • Part 32.74 - Sealed sources and devices for medical use
  • Part 32.30 - Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer

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Guidance

Consolidated materials guidance is published in "Consolidated Guidance About Materials Licenses" (NUREG-1556), Volume 3, Applications for Sealed Source and Device Evaluation and Registration).

Other guidance that may be of interest to applicants and licensees may be found in Information Notice 96-20, Demonstration of Associated Equipment Compliance with 10 CFR 34.20, April 4, 1996.

Regulatory Issue Summary RIS 13-01, Use Of Aftermarket Sealed Sources Registered Under 10 CFR 32.210.

Registration Certificate Types

The NRC registers sealed sources, devices, and sealed source/device combinations.

Fees

Holders of sealed source and device certificates are required to pay an annual license fee to the NRC. Refer to the schedule of materials fees for the fees required.

Forms

See "Applications for Sealed Source and Device Evaluation and Registration" (NUREG-1556, Vol. 3, Rev. 2), especially Section 6, How to File and Appendix A, Application and Review Checklist.

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