Betrieb einer Röntgeneinrichtung oder wesentliche Änderung des Betriebs anzeigen

§ 12 para. 1 no. 4 Radiation Protection Act - StrlSchG

If you operate a mobile X-ray unit in connection with an application on animals in veterinary medicine or if this approved activity changes significantly, you are obliged to notify the competent authority in order to obtain a permit.

With the permit for a veterinary X-ray facility, you can put the facility into operation or make significant changes to it in accordance with the permit.

Please note that the permit relates to the person named as the radiation protection officer. If there are changes in this area, these must also be reported to the authority.

An example of other significant changes is the change of the image receiver of the approved X-ray equipment.

You need the following documents for the application for permits:

1. plans, drawings and descriptions required to check the conditions for approval,

2. information that makes it possible to check whether
a) the number of radiation protection officers necessary for the safe performance of the activity has been appointed and that they have been granted the necessary powers to perform their duties,
b) it is ensured that the equipment is available and measures have been taken which are necessary according to the state of the art to ensure that the protection regulations are complied with,

3. information that makes it possible to check whether the person responsible for radiation protection and the radiation protection officers are reliable and have the necessary expertise in radiation protection,

4. a copy of a radiation protection instruction in accordance with the legal ordinance, if a radiation protection instruction is required,

I.e. in particular:

• Proof of specialist knowledge in radiation protection including proof of updating
• Certificate and test report on radiation protection testing of the device by an expert or an expert organization
• Type approval certificate with confirmation of routine testing or CE certificate of conformity
• Proof of knowledge of radiation protection for the personnel deployed, including updates of these certificates

In the case of approval of equipment for use on animals, you also need to submit a license to practice medicine or proof of temporary exercise of the medical profession.

You will receive approval if the legal requirements for approval are met.

These are fulfilled if:

1. there are no facts that give rise to concerns about the reliability of the applicant, their legal representative or, in the case of legal entities or associations of persons without legal capacity, the persons authorized to represent or manage them in accordance with the law, articles of association or partnership agreement and, if a radiation protection officer is not required, one of the aforementioned natural persons has the necessary expertise in radiation protection,
2. Furthermore, a license to practice medicine or a temporary authorization to practice medicine exists.
3. there are no other public law regulations to the contrary.
4. it is not an unjustified type of activity according to a legal regulation or if, taking into account a published report, there are no significant doubts about the justification of the type of activity and
5. it is ensured that the equipment is available and the measures are taken which, in the case of an activity, are necessary according to the state of the art so that the safety regulations are complied with,
6. there are no facts giving rise to doubts as to whether the personnel required to carry out the activity safely are available,
7. it is ensured that the persons otherwise involved in the activity have the necessary knowledge and skills with regard to the possible radiation hazard and the protective measures to be applied,
8. the number of radiation protection officers necessary for the safe performance of the activity has been appointed and they have been granted the powers necessary for the performance of their duties,
9. there are no facts that give rise to concerns about the reliability of the radiation protection officers and they have the necessary expertise in radiation protection,

As the operator of an X-ray machine, you must apply for a permit for operation or for a significant change.

The authority will first check your application for completeness. The second step is to check whether all requirements are met.

Documents may be requested at a later stage. The permit will be issued to you in writing.

Before commissioning or before making the significant change.

You must obtain approval before commissioning the system. The same applies to the planning of significant changes.

You can take legal action if the authority does not grant the permit or if you wish to take legal action against the permit.

• Operation of an X-ray facility for use on animals in veterinary medicine or significant modification of the facility Issue
  • The operation of X-ray equipment in connection with an animal in veterinary medicine must be approved
  • Significant changes to an already approved facility must also be approved
  • This does not apply to X-ray equipment for the operation of which it is sufficient, also taking into account the need for approval

• Responsible: Saxony-Anhalt State Office for Consumer Protection - Department 51.4 Radiation Protection

Please contact the Saxony-Anhalt State Office for Consumer Protection
Department 51.4 Radiation protection

Forms available: Yes

Written form required: Yes

Informal application possible: No

Personal appearance necessary: No
Online services available: No