Genehmigung für den Betrieb einer Röntgeneinrichtung oder die wesentliche Änderung des Betriebs zur Teleradiologie beantragen

Would you like to operate a teleradiology X-ray facility or make significant changes to it? Then you must first apply for a permit from the competent authority.

With the permit, you may put a teleradiology X-ray system into operation or make significant changes to it.

Significant changes to a teleradiology X-ray system can be, for example

• Change of room
• Structural changes to the room
• Change of the image receiver

The authority will first check whether you have submitted all the necessary documents and meet the legal requirements. Changes in the personnel of the radiation protection officer must also be reported again. If there are no objections to the commissioning or modification, you will receive the permit.

If it is a construction procedure, it may make sense to involve the responsible radiation protection authority at an early stage.

In addition to the main application for approval, the following documents must be submitted:

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 if it is necessary to issue a radiation protection instruction,

This means in particular

• Proof of expertise 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 to these certificates

• There are no concerns about the reliability of the applicant or the radiation protection officer.
• The radiation protection officer must have the necessary expertise in radiation protection.
• You need a sufficient number of radiation protection officers and they must have the necessary authorizations for their tasks.
• You need sufficient personnel to carry out the work safely.
• They must have sufficient equipment and appropriate measures to comply with state-of-the-art protection regulations.
• This is a justified type of activity and does not conflict with any other public law regulations.

• As the operator of an X-ray machine, you must apply for a permit to operate it or for a significant change.
• If it is a construction procedure, it may make sense to involve the radiation protection authority at an early stage.
• 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.

You must submit the permit application before commissioning the X-ray equipment. You may only put the X-ray equipment into operation once the permit has been issued.

Before commissioning the X-ray equipment.

There are no indications or special features.

Action before the administrative court

• Operation of an X-ray facility or significant change in operation Authorization for teleradiology
• Companies with teleradiology X-ray facilities must obtain a permit for their operation if
  • they wish to put the X-ray equipment into operation for the first time
  • wish to make significant changes to the operation of the X-ray equipment, e.g:
    • change of room
    • structural changes to the room
    • change of the image receiver
• The requirements and evidence necessary for the application relate, for example, to
  • the reliability of the applicant
  • the reliability and expertise of the radiation protection officer
  • equipment and measures taken to comply with the protection regulations
  • justification of the type of activity
• Application for approval must be submitted prior to the commissioning or implementation of the modification of a teleradiology X-ray facility
• Responsible: competent authority for radiation protection

Responsible: Department of Radiation Protection in the Ministry for Energy Transition, Climate Protection, Environment and Nature of the State of Schleswig-Holstein (MEKUN)

Ministry for Energy Transition, Climate Protection, Environment and Nature of the State of Schleswig-Holstein

Department of Radiation Protection at theMinistry for Energy Transition, Climate Protection, Environment and Nature of the State of Schleswig-Holstein (MEKUN)