Canada Amends Radiation Regulations for Dental Equipment
08 December 2017
The Canadian government has amended the current radiation regulations for X-ray dental equipment effective 15 May 2018 in an effort to strengthen radiation safety requirements - in alignment with International Electrotechnical Commission standards - for new equipment, broaden the scope of the current regulations to address new and modern dental X-ray technologies (such as cone beam computer tomography and hand-held equipment) and require the provision of information to support optimisation of equipment use, such as quality control specifications.
The amendments will require manufacturers to provide additional information for each piece of dental X-ray equipment, including quality control procedures and dosimetric information. These information requirements are more extensive than what is currently addressed in the regulations and provide operators with the ability to properly operate and maintain their machines, ensuring consistent and appropriate patient dose delivery. Canadian authorities have also introduced a new requirement for a label on transportable hand-held dental X-ray equipment to inform operators of radiation safety considerations associated with these devices.
Requirements in the current regulations for X-ray dental equipment have been amended with respect to such features as minimum tube voltage setting (by increasing it from 50 kV to 60 kV), exit field size for intra-oral devices (by reducing the maximum diameter from seven to six centimetres), radiation absorbing filters (by increasing the minimum attenuation requirements for extra-oral devices), X-ray field limitations (by including requirements specific to CBCT machines) and focal spot to skin distance (by increasing to 20 cm for intra-oral devices). Canadian authorities believe these changes will reduce the radiation risk to which the patient and operator are exposed during the operation of the X-ray device. In addition, the amendments will enable the importation and sale of transportable hand-held intra-oral dental devices in Canada while introducing requirements to mitigate radiation risks from these devices.
- Medical Supplies & Medicine
- North America