Dental X-ray machines

Dental X-ray equipment should be designed, constructed and installed to be
in compliance with recognised European standards pertaining to all aspects of
equipment safety (e.g. electrical, mechanical and radiation protection).

Dental X-ray equipments

It must meet the relevant essential requirements for safety and performance of
the Medical Devices Directive. All products that fall within the scope of the Directive must meet certain essential safety and administrative requirements and are to be CE marked to show that they comply. Such products may then be freely sold throughout the EU without being subject to additional national regulations. It is required that suppliers, erectors or installers of dental X-ray equipment provide adequate information pertinent to the proper use, testing and maintenance of the equipment. In some member states there maybe further requirements relating to the supply of X-ray machines.

Dental X-ray machines

In addition, the European Council Directives  covering the use of ionising
radiation , place requirements on equipment owners to ensure
equipment is tested so that the safety of both staff using the equipment and
patients undergoing diagnosis is optimised. The overall aim being to ensure
that dose to both staff and patients is kept as low as reasonably achievable.

Dental X-ray machines maintenance and testing

It is essential that the features of dental X-ray machines pertaining to the
radiation safety of both users and patients be correctly maintained. To ensure
this, the equipment needs to be in good mechanical and electrical order.
Regular maintenance and associated checks should be performed in
accordance with the recommendations of the manufacturer, the supplier, and
the qualified expert/medical physics expert. As well as the actual X-ray
equipment, it should be remembered that automatic processors should be
subject to a regular maintenance programme to ensure that they are
operating optimally as this has a direct effect on patient dose.
Dental X-ray equipment should be subject to the following inspections/tests
:
_ Critical examination of plans for installation from the point of view of
radiation safety of staff and members of the public
_ Acceptance test – performed prior to the equipment’s use in clinical
practice
_ Routine tests – these should be performed at regular intervals and
following any significant maintenance procedure
The exact arrangements for carrying out these tests on dental X-ray
machines and the criteria for remedial action vary from country to country
within the EU dependent on local legislative requirements and guidance.
Qualified experts or medical physics experts should normally be involved.
European criteria of acceptability have been established for intraoral
radiography units and it is also recommended that the European criteria for
general radiographic units can be applied to cephalometric units. In
general, there is a significant level of agreement with regard to the main
features to be tested and criteria of acceptability .