Exemptions

In accordance with the provisions of Article 20 of the Regulation on Authorizations for Radiation Facilities and Radiation Applications, devices that produce radiation with voltage less than or equal to 30 kV are exempt from authorization obligations, provided that the dose rate does not exceed 1 µSv/hour (0.1 mrem/hour) at any point 10 cm away from their accessible surfaces under normal operating conditions.

Radiation-generating devices operating with a voltage above 30 kV may be exempted from the obligations regarding authorization by being evaluated by the Authority, provided that the dose rate does not exceed 1 µSv/hour (0.1 mrem/hour) at any point 10 cm away from the accessible surfaces under normal operating conditions and provided that they are used safely.

The companies that will apply to the Authority to be evaluated within the scope of exemption must send a document (For example, type approval certificate issued by the German Federal Office for Radiation Protection –BfS-) showing that the dose rate measurements taken at a distance of 10 cm from all surfaces of the device by the authorized organizations (regulatory bodies in the country where the radiation sources are produced or organizations authorized by regulatory bodies) do not exceed 1 µSv/hour (0.1 mrem/saat), or a document indicating that the device has been exempted by the regulatory authirities. In addition, technical documents containing the kV, mA values of the device and the dose rate values read on the surfaces of the device should also be sent.

Within the framework of harmonization studies with the European Union Acquis carried out by the Authority, during activities related to the use of ionizing radiation sources, within the framework of ensuring parallelism with Directive 96/29/EURATOM dated 13.05.1996, which determines the principles for the protection of individuals, society and the environment from the harmful effects of ionizing radiation, for electrical devices that are deemed appropriate for use by the Authority taking into account their advantages against possible damages, in accordance with the provisions of the Article 20 of the Regulation, the notification obligation will continue and these devices may be exempted from the obligations regarding authorization.

Exemptions granted by the Authority may be revoked when deemed necessary in terms of radiation safety and the security of radioactive sources. An application for authorization is required for radiation sources whose exemption has been revoked.

X-RAY DEVICES WITH LICENSE EXEMPTION TO USE AND OWN

As a result of the examination of the documents submitted to the Authority, the devices with the following features are exempted from authorization, provided that they notify the Authority together with their technical catalogue.

X-RAY DEVICES EXEMPTED FROM LICENSING