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Laws and Rules - X-Ray Machines and Services


NOTICE

On March 19, 2020, DSHS Radiation Control began receiving information that some medical facilities are limiting access to vendors due to restrictions they have implemented because of COVID-19. Those prohibitions include restricting or barring access to licensed medical physicists who conduct required machine testing, which would result in a delay in conducting physics surveys. 

The current Texas regulations on mammography, fluoroscopy, computed tomography, and other x-ray devices require testing at a specified interval. DSHS also aligns its practices to guidance offered by federal regulatory agencies such as the U.S. Food and Drug Administration. 

DSHS supports facilities’ efforts to protect public health and offers the following guidance for registrants to ensure a continuity of radiation safety during COVID-19-related restrictions. This is a fluid situation and subject to change. 
 
Mammography Devices
The U.S. Food and Drug Administration has a policy for mammography devices that allows facilities to notify their state inspector or state certifying agency and request permission in writing to defer the current survey until the extenuating circumstance(s) is no longer applicable. The policy requires facilities to make the notification before the expiration of their current physics survey.  

In its request, the facility must include the date the survey expires, explain in writing the reason for the requested deferral, and propose a schedule showing the date by which the deferred physics survey will be completed. As the date when COVID-19 restrictions will end and the resources available for testing at the end of restrictions may be unknown at this time, the facility may satisfy this requirement by describing the efforts they plan to take in the three months immediately following the survey expiration. The department understands this proposed schedule may need to be amended.  
 
Quality assurance testing will still need to be performed by the facility for as long as they continue to perform imaging procedures. In situations where the mammography device requires repair before being used, the facility will direct patients to a facility with properly working mammography devices until the repairs and testing can be completed.  
 
Mammography facilities should notify Trae Windham at trae.windham@dshs.texas.gov to request permission to defer the current survey.
 
Fluoroscopy, Computed Tomography, and Other X-Ray Devices
If the physics survey is delayed due to circumstances related to COVID-19, the facility is required to document the issue and determine a schedule to have the required testing completed. This documentation should start before the current physics survey expires. If the proposed schedule needs to be amended, the facility should update their documentation. This documentation should be made available to department inspection staff upon request. In situations where the x-ray device requires repair before being used, the facility will direct patients to a facility with properly working x-ray devices until the repairs and testing can be completed.  
 
Questions can be sent to RadiationXRayInspections@dshs.texas.gov


Table of Contents


Texas Laws - Health and Safety Code

Texas Laws and Statutes Governing Radiation Control
Statute Title
Chapter 401 Radioactive Materials and Other Sources of Radiation

X-Ray Machine Registration Rules - Title 25, Texas Administrative Code


Medical X-Ray

Rules Covering Registration of Medical X-Ray Machines
Rule Title Revision Date
§289.203 (HTML)
§289.203 (PDF, 109KB)
Notices, Instructions, and Reports To Workers; Inspections 10/01/11
RC Form 203-1
(PDF, 65KB)
"Notice to Employees" RC Form 203-1 (standalone document) 10/01/11
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.205 (HTML)
§289.205 (PDF, 91KB)
Hearing and Enforcement Procedures 12/27/07
§289.226 (HTML)
§289.226 (PDF, 199KB)
Registration of Radiation Machine Use and Services 12/17/13
§289.227 (HTML)
§289.227 (PDF, 328KB)
Use of Radiation Machines in the Healing Arts
See Note 289.227
05/01/13
§289.227 - FAQs
(PDF, 357KB)
Questions and Answers - 25 TAC §289.227, Use of Radiation Machines in the Healing Arts 01/13/15
§289.230 (HTML)
§289.230 (PDF, 309KB)
Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography 04/29/12
§289.231 (HTML)
§289.231 (PDF, 280KB)
General Provisions and Standards for Protection Against Machine-Produced Radiation 12/29/11

Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices

Rules Covering Registration of Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices
Rule Title Revision Date
§289.203 (HTML)
§289.203 (PDF, 109KB)
Notices, Instructions, and Reports To Workers; Inspections 10/01/11
RC Form 203-1
(PDF, 65KB)
"Notice to Employees" RC Form 203-1 (standalone document) 10/01/11
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.205 (HTML)
§289.205 (PDF, 91KB)
Hearing and Enforcement Procedures 12/27/07
§289.226 (HTML)
§289.226 (PDF, 199KB)
Registration of Radiation Machine Use and Services 12/17/13
§289.227 (HTML)
§289.227 (PDF, 328KB)
Use of Radiation Machines in the Healing Arts
See Note 289.227
05/01/13
§289.227 - FAQs
(PDF, 357KB)
Questions and Answers - 25 TAC §289.227, Use of Radiation Machines in the Healing Arts 01/13/15
§289.229 (HTML)
§289.229 (PDF, 338KB)
Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices 12/29/11
§289.231 (HTML)
§289.231 (PDF, 280KB)
General Provisions and Standards for Protection Against Machine-Produced Radiation 12/29/11

Dental X-Ray (Includes Cone Beam CT)

Rules Covering Registration of Dental X-Ray Machines, Including Cone Beam CT
Rule Title Revision Date
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.232 (HTML)
§289.232 (PDF, 852KB)
Radiation Control Regulations for Dental Radiation Machines 06/25/19
§289.232(i)(5)(B)(iii) (PDF, 44KB) "Notice to Employees" RC Form 232-1 (for Dentists only) 06/25/19
Texas Dental Association Podcast (HTML)
TDA SoundByte Episode 5: The Truth about New Dental X-Ray Equipment Regulations
2/14/20

Veterinary X-Ray Machines

Rules Covering Registration of Veterinary X-Ray Machines
Rule Title Revision Date
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.233 (HTML)
§289.233 (PDF, 654KB)
Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine 10/12/08
§289.233(i)(3)(F)(vii) (PDF, 32KB) "Occupational Exposure Record" RC Form 233-1 (for Veterinarians Only) 10/12/08
§289.233(i)(4)(B)(iii) (PDF, 66KB) "Notice to Employees" RC Form 233-2 (for Veterinarians Only) 10/12/08

Veterinary X-Ray with Accelerator

Rules Covering Registration of Veterinary X-Ray Machines
Rule Title Revision Date
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.229 (HTML)
§289.229 (PDF, 338KB)
Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices 12/29/11
§289.233 (HTML)
§289.233 (PDF, 654KB)
Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine 10/12/08
§289.233(i)(3)(F)(vii) (PDF, 32KB) "Occupational Exposure Record" RC Form 233-1 (for Veterinarians Only) 10/12/08
§289.233(i)(4)(B)(iii) (PDF, 66KB) "Notice to Employees" RC Form 233-2 (for Veterinarians Only) 10/12/08

Industrial X-Ray Machines (Includes Minimal Threat)

Rules Covering Registration of Industrial X-Ray Machines, Including Minimal Threat
Rule Title Revision Date
§289.203 (HTML)
§289.203 (PDF, 109KB)
Notices, Instructions, and Reports To Workers; Inspections 10/01/11
RC Form 203-1
(PDF, 65KB)
"Notice to Employees" RC Form 203-1 (standalone document) 10/01/11
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.205 (HTML)
§289.205 (PDF, 91KB)
Hearing and Enforcement Procedures 12/27/07
§289.226 (HTML)
§289.226 (PDF, 199KB)
Registration of Radiation Machine Use and Services 12/17/13
§289.228 (HTML)
§289.228 (PDF, 104KB)
Radiation Safety Requirements for Analytical and Other Industrial Radiation Machines 05/01/08
§289.231 (HTML)
§289.231 (PDF, 280KB)
General Provisions and Standards for Protection Against Machine-Produced Radiation 12/29/11

Industrial Radiography X-Ray Machines

Rules Covering Registration of Industrial Radiography X-Ray Machines
Rule Title Revision Date
§289.203 (HTML)
§289.203 (PDF, 109KB)
Notices, Instructions, and Reports To Workers; Inspections 10/01/11
RC Form 203-1
(PDF, 65KB)
"Notice to Employees" RC Form 203-1 (standalone document) 10/01/11
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.205 (HTML)
§289.205 (PDF, 91KB)
Hearing and Enforcement Procedures 12/27/07
§289.226 (HTML)
§289.226 (PDF, 199KB)
Registration of Radiation Machine Use and Services 12/17/13
§289.228 (HTML)
§289.228 (PDF, 104KB)
Radiation Safety Requirements for Analytical and Other Industrial Radiation Machines 05/01/08
§289.231 (HTML)
§289.231 (PDF, 280KB)
General Provisions and Standards for Protection Against Machine-Produced Radiation 12/29/11
§289.255 (HTML)
§289.255 (PDF, 217KB)
Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography 03/22/15

Industrial X-Ray Accelerator

Rules Covering Registration of Industrial X-Ray Accelerators
Rule Title Revision Date
§289.203 (HTML)
§289.203 (PDF, 109KB)
Notices, Instructions, and Reports To Workers; Inspections 10/01/11
RC Form 203-1
(PDF, 65KB)
"Notice to Employees" RC Form 203-1 (standalone document) 10/01/11
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.205 (HTML)
§289.205 (PDF, 91KB)
Hearing and Enforcement Procedures 12/27/07
§289.226 (HTML)
§289.226 (PDF, 199KB)
Registration of Radiation Machine Use and Services 12/17/13
§289.228 (HTML)
§289.228 (PDF, 104KB)
Radiation Safety Requirements for Analytical and Other Industrial Radiation Machines 05/01/08
§289.229 (HTML)
§289.229 (PDF, 338KB)
Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices 12/29/11
§289.231 (HTML)
§289.231 (PDF, 280KB)
General Provisions and Standards for Protection Against Machine-Produced Radiation 12/29/11

X-Ray Service Companies

Rules Covering X-Ray Service Companies
Rule Title Revision Date
§289.203 (HTML)
§289.203 (PDF, 109KB)
Notices, Instructions, and Reports To Workers; Inspections 10/01/11
RC Form 203-1
(PDF, 65KB)
"Notice to Employees" RC Form 203-1 (standalone document) 10/01/11
§289.204 (HTML)
§289.204 (PDF, 85KB)
Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services 09/07/14
§289.205 (HTML)
§289.205 (PDF, 91KB)
Hearing and Enforcement Procedures 12/27/07
§289.226 (HTML)
§289.226 (PDF, 199KB)
Registration of Radiation Machine Use and Services 12/17/13
§289.227 (HTML)
§289.227 (PDF, 328KB)
Use of Radiation Machines in the Healing Arts
See Note 289.227
05/01/13
§289.227 - FAQs
(PDF, 357KB)
Questions and Answers - 25 TAC §289.227, Use of Radiation Machines in the Healing Arts 01/13/15
§289.228 (HTML)
§289.228 (PDF, 104KB)
Radiation Safety Requirements for Analytical and Other Industrial Radiation Machines 05/01/08
§289.229 (HTML)
§289.229 (PDF, 338KB)
Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices 12/29/11
§289.230 (HTML)
§289.230 (PDF, 309KB)
Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography 04/29/12
§289.231 (HTML)
§289.231 (PDF, 280KB)
General Provisions and Standards for Protection Against Machine-Produced Radiation 12/29/11
§289.232 (HTML)
§289.232 (PDF, 572KB)
Radiation Control Regulations for Dental Radiation Machines 10/12/08
§289.233 (HTML)
§289.233 (PDF, 654KB)
Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine 10/12/08

Notes Regarding Specific Rules

§289.227 - View the DSHS letter sent to registrants and other interested parties:


Last updated May 29, 2020