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Sealed Sources and Devices Toolkit

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

On this page:

• Regulations
• Guidance
• Registration Certificate Types
• Fees
• Forms

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, 34.21. 34.22, 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

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).

Regulatory guides are issued in 10 divisions and are intended to aid licensees and others in implementing regulations. The guides most applicable to nuclear materials are in

• Division 6, Products
• Division 8, Occupational Health

The guide most applicable to sealed source and device registration is Regulatory Guide 6.9, Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material.

Web (HTML) versions of some regulatory guides are available for viewing or downloading at this site. In the index for each division of guides, the number of each guide available at this site is underscored. All active final and draft guides are also available in NRC's Agencywide Documents Access and Management System (ADAMS).

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.

Registration Certificate Types

We register either sealed sources or sealed source and device combinations.

Fees

Holders of sealed source and device certificates are required to pay an annual license fee to the NRC. These fees are explained in our Materials Fee Billing Handbook. 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. 1), especially Section 6 , How to File and Appendix A , Application and Review Checklist.

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Tuesday, February 13, 2007