All x-ray equipment must comply with the Medical Devices Regulations 2002 (as amended) [1] and have CE marking, which indicates that the equipment complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
* Note: Following Brexit, medical devices placed on the GB market will have a UKCA mark. This UKCA mark is a requirement of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) [1].
All x-ray equipment must be properly maintained and tested, according to the advice of the manufacturer, the supplier and your Radiation Protection Adviser (RPA).
Suppliers, erectors and installers of dental x-ray equipment are required under the Ionising Radiations Regulations 2017 (IRR17) [2] and the Medical Device Regulations 2002 [1] to provide the Employer with adequate information about the proper use, testing and maintenance of the equipment.
The recommendations and advice in the following sections refer to conventional intra-oral and panoramic x-ray machines.
For information on the recommended specifications, testing and use of hand-held dental x-ray equipment refer to the ‘Guidance on the Safe Use of Hand-held Dental X-ray equipment’ [3] Note that Chapter 4 of this document has been superseded by the ‘Guidance Notes for Dental Practitioners on the Safe Use of X-ray Equipment’ [4].
For guidance on CBCT refer to the ‘Guidance Notes for Dental Practitioners on the Safe Use of X-ray Equipment’ [4].
Sources of information
- The Medical Devices Regulations 2002 (as amended)
- The Ionising Radiations Regulations 2017
- Guidance on the Safe Use of Hand-held Dental X-ray Equipment (2016) Public Health England
- Guidance Notes for Dental Practitioners on the Safe Use of X-ray Equipment (2nd edition) (2020) Faculty of General Dental Practice (UK)