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Source: BUS Sachsen-Anhalt (Linie6PLus)

Apply for approval for the operation of an X-ray facility or the significant modification of the operation for teleradiology

Description

The permit allows you to put a teleradiology X-ray system into operation or make significant changes to it. Before you receive the permit, the authority will check whether you have submitted all the necessary documents and whether the legal requirements are met. Changes in the personnel of the radiation protection officer must also be reported again. Examples of other significant changes are

  • a change of room,
  • the image receiver
  • or structural changes to the room.

Approval will be granted if the relevant requirements are met. The requirements are met if

  1. there are no facts that give rise to concerns about the reliability of the applicant, his or her legal representative or, in the case of legal entities or associations of persons without legal capacity, the persons authorized to represent or manage them by 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. 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,
  3. the number of radiation protection officers necessary for the safe performance of the activity has been appointed and they have been granted the necessary powers to perform their duties,
  4. 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,
  5. there are no facts giving rise to doubts as to whether the personnel required to carry out the activity safely are available,
  6. it is ensured that the equipment is available and that the measures are taken which, in the case of an activity in accordance with § 12 paragraph 1 number 4, are necessary according to the state of the art so that the protective regulations are complied with,
  7. it is not an unjustified type of activity in accordance with an ordinance pursuant to Section 6 (3) or if, taking into account a report published in accordance with Section 7 (2), there are no significant doubts as to the justification of the type of activity, and
  8. other provisions of public law do not conflict with this.

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 carry out 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,

i.e. 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

Before commissioning the X-ray equipment

  • 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.

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

The text was automatically translated based on the German content.

Authority
Landesamt für Verbraucherschutz
Freiimfelder Straße 68
06112 Halle (Saale), Stadt
Remark: The head office is located in Halle (Saale). The addresses of the individual locations can be found on the website of the State Office for Consumer Protection.
0345 52162200
0345 5643439

Monday 07:00 - 16:00

Tuesday 07:00 - 16:00

Wednesday 07:00 - 16:00

Thursday 07:00 - 16:00

Friday 07:00 - 15:30

Saturday closed

Sunday closed

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