Does new handheld x-ray equipment require a critical examination?

Does new handheld x-ray equipment require a critical examination?

Regulation 32 of the Ionising Radiations Regulations requires the installer of equipment to undertake tests to demonstrate that the basic safety features of the equipment are working correctly. In addition an ‘acceptance test’ should be carried out by the dental practice for the purposes of the Ionising Radiation (Medical Exposure) Regulations to ensure adequate clinical performance of the equipment.

For handheld equipment, these tests may either be carried out by the supplier at the point of sale, or alternatively by a dental service agent engaged by the practice. The tests must be of the individual item of equipment supplied; type-test data for the type of equipment supplied is not sufficient.

The HSE have recently provided the following clarification which may be helpful:

“IRR17 Regulation 32(2) Critical Examination
This regulation requires a person who “erects or installs an article” to “to undertake a critical examination”. HSE’s legal advisers have recently clarified that this applies to any item of “work with ionising radiation” that is brought into use. This includes articles that might be considered “mobile” devices (i.e. those not requiring any physical/mechanical fixings). Whilst it may have been customary to say that mobile equipment did not require a Critical Examination, it has always been HSE’s expectation that safety features and warning devices, etc, should be checked before first use and the medical sector has typically been able to demonstrate that that this takes place. RPAs would usually be involved in determining the nature and extent of these tests, as well as being consulted if any anomalies were found.
In keeping with the above legal advice, these tests should now be referred to as a Critical Examination. The levels of testing HSE has observed appear to be fit for purpose and no additional tests should be required. Further to this, there is no need to conduct a new Critical Examination on any equipment already in use, providing that appropriate tests have been carried out and this can be demonstrated.”