Pennsylvania Portable X-ray Regulations

Dec 15, 2022 6:49:34 AM / by Chad Hutchison

The Department of Environmental Protection, Radiation Protection program manages all licensing, registration, and regulations for portable x-rays in the state of Pennsylvania. 

X-ray License in Pennsylvania

Any individual who operates an X-ray machine shall be instructed adequately in safe operating procedures and be competent in the safe use of the equipment. 

Once an operator is adequately instructed, you must have continuing education in the key areas of:

  • Radiation safety
  • Biological effects of radiation
  • Quality assurance and quality control to ensure ongoing competence

The Bureau of Radiation Protection (BRP) radiological requirements of 25 Pa. Code 221.11(b) have specific requirements for the determination of competence and continuing education; they apply to all operators of diagnostic X-ray equipment.

Registering an X-ray Device

The Radiation Control Division is responsible for the registration of 11,000+ facilities possessing over 33,000 X-ray units. By regulation under 25 Pa. Code Chapter 216.2, handheld units that use an X-ray tube must be registered as radiation-producing machines with the Department of Environmental Protection’s (DEP) Bureau of Radiation Protection within 30 days of acquisition.

Regulations for Portable X-ray Equipment

Requirements When Using Handheld Analytical X-ray Equipment

An important safety requirement applies when using portable devices in Pennsylvania. Because most handheld units do not have a safety device (interlock) as required by 25 Pa. Code, Chapter 227.11a, you must apply to the DEP for an exemption from this regulation prior to use. 

  • Mandated training must be provided to the operators, and documented records must be maintained. (25 Pa. Code, Chapter 227.14)
  •  Safety device inspection and checks, e.g., lights and LCD readouts, shall be performed at least annually and documented for review by the department. (25 Pa. Code, Chapter 227.12a(e))
  • Operating procedures shall be written and available to operators of the analytical equipment. (25 Pa. Code, Chapter 227.13a(a))
  • Emergency procedures shall be written and available to operators of the analytical equipment. (25 Pa. Code, Chapter 227.13a(d))
  • A written radiation safety program based on the radiation protection principles that are as low as reasonably achievable shall be developed, documented and implemented. The radiation protection program shall be reviewed at least annually. (25 Pa. Code, Chapter 219.5 and 10 CFR 20.1101)
  • Analytical X-ray equipment shall be labeled “CAUTION RADIATION – THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED” or words having a similar intent. Unless the device produces high intensity X-rays, no further labeling is required. (25 Pa. Code, Chapter 227.11a(f)(2))
  • Personnel dosimeters, preferably finger and/or wrist dosimeters, are required to be worn during operation. Exposure records shall be maintained by the facility and available to the operator. (25 Pa. Code, Chapter 227.14(b))
  •  The registrant must maintain control of the device at all times to prevent theft or operation by an unauthorized user. (25 Pa. Code, Chapter 219.132)

 

Disclaimer: The information in this document is solely for reference material. Regulations change often. To be sure of the most up-to-date laws, contact your local and state agencies.

Additional Resources

Bureau of Professional and Occupational Affairs 

State Board of Medicine 

P.O. Box 2649

Harrisburg, PA 17105-2649

(717) 783-5919

Pennsylvania Radiology License

Bureau of Radiation Protection

Department of Environmental Protection

Bureau of Radiation Protection

P.O. Box 8469

Harrisburg, Pennsylvania 17105-8469

(717) 787-3720

Tags: Portable X-ray Regulations

Chad Hutchison

Written by Chad Hutchison

Founder and CEO of Maven Imaging, Chad Hutchison has been in the medical imaging equipment market since 2003. As his business grew, he pioneered buying and selling medical equipment online and eventually began offering leasing and financing to meet market demands and help customers. His market expertise goes beyond traditional medical imaging and finance support, as he’s spearheading cloud-based lending solutions for vendors across the sector.