South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-64 - X-Rays (Title B)
Part I - GENERAL PROVISIONS
Section 61-64.I.RHB 1.10 - Records

Universal Citation: SC Code Regs 61-64.I.RHB 1.10

Current through Register Vol. 48, No. 9, September 27, 2024

1.10.1 Each registrant shall keep records showing the receipt, transfer, use, storage, and disposal of all sources of radiation and major components, including, but not limited to, controls, tubes, tables, cassette holders, and transformers. The registrant shall maintain these records until disposal is authorized by the Department. Such authorization shall be made in writing. All records shall be readily available at the facility for Departmental review. Additional record requirements are specified elsewhere in this regulation.

1.10.2 The registrant shall maintain the following information for each x-ray system for inspection by the Department:

1.10.2.1 Model and serial numbers of all tubes, controls, and beam limiting devices;

1.10.2.2 Tube rating charts and cooling curves, for units certified by the U.S. Food and Drug Administration, and for units regulated under Part IV and Part V;

1.10.2.3 Aluminum equivalent filtration of the useful beam, including any routine variation for units regulated under Part IV and Part V;

1.10.2.4 Records of surveys, tests, equipment performance tests, maintenance, and modifications performed on the x-ray system(s), with the names of persons who performed such services. Records shall be maintained for five (5) years; until the next Department inspection; or until the registrant no longer possesses the equipment; and

1.10.2.5 A copy of all correspondence with the Department regarding that x-ray system.

1.10.3 Each registrant shall maintain a current inventory listing that indicates the model number, serial number, shielding acceptance number (if applicable), date of last equipment performance test, location and status of each control, and identification of each control or generator installed since the last Departmental inspection including the date of installation. The inventory listing shall be made available to the Department upon request.

1.10.4 All records required by this regulation shall be accurate and true.

1.10.5 Each record required by this Part shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The registrant shall maintain adequate safeguards against tampering with and loss of records.

Disclaimer: These regulations may not be the most recent version. South Carolina may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.