Apply for the operation of an X-ray facility or report a significant change in operation

Prerequisites

Approval is granted if the legal approval requirements according to §§ 13 and 15 StrlSchG are met.
These are fulfilled if :

1. there are no facts that give rise to doubts about the reliability of the applicant, his legal representative or, in the case of legal persons or unincorporated associations of persons, the person entitled to represent or manage the company under the law, the articles of association or the articles of association and, if a radiation protection officer is not necessary, a of the natural persons named has the necessary expertise in radiation protection,
2. there are no facts that give rise to doubts about the reliability of the radiation protection officers and they have the necessary expertise in radiation protection,
3. the number of radiation protection officers required for safe execution of the activity has been appointed and they have been granted the powers required to fulfill their tasks,
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 taken,
5. there are no facts that give rise to doubts as to whether the personnel required to carry out the work safely are available,
6. it is guaranteed that the equipment is available and the measures have been taken which, in the case of an activity according to Article 12 paragraph 1 number 4, are required according to the state of the art so that the protective regulations are observed,
7. it is not an unjustified type of activity according to an ordinance pursuant to Section 6 Paragraph 3 or if, taking into account a report published pursuant to Section 7 Paragraph 2, there are no significant doubts as to the justification of the type of activity and
8. other public law regulations do not conflict.
9. Furthermore, a license to practice medicine or a temporary authorization to practice a medical profession according to § 15 StrlSchG is available.

Documents required

§ 16 StrlSchG: Required documents for the application for permits according to § 12 paragraph 1 number 4

1. Plans, drawings and descriptions that are necessary to check the approval requirements,
2. Information that makes it possible to check whether
   1. the number of radiation protection officers required for safe execution of the activity has been appointed and they have been granted the powers required to fulfill their tasks,
   2. it is guaranteed that the equipment is available and that state-of-the-art measures have been taken to ensure compliance with the protective regulations,
3. Information that makes it possible to check whether the radiation protection officer and the radiation protection officer are reliable and have the necessary expertise in radiation protection,
4. a copy of a radiation protection instruction in accordance with the ordinance pursuant to Section 73, if the issuance of a radiation protection instruction is required,

Ie in particular:

• Proof of expertise in radiation protection including proof of updating
• Certificate and test report on the radiation protection test of the device by an expert or an expert organization
• Type approval certificate with proof of the result of the quality control or CE certificate of conformity
• Evidence of knowledge of radiation protection for the personnel deployed, including proof of updating

§ 15 StrlSchG: Special requirements
In the case of approvals for X-ray equipment for use on animals in veterinary medicine, a license to practice medicine or proof of temporary exercise of the medical profession by the applicant or the radiation protection officer appointed by him must be submitted.

Please note

Approval must be obtained before the system is put into operation. The same applies to the planning of significant changes.

Deadlines

No

Procedure

As the operator of an X-ray machine, you must apply for approval for operation or for a significant change.
The authority will first check your application for completeness. In the second step, it is checked whether all the requirements are met.
Documents may be requested later. Approval will be given to you in writing.

Fees

No costs

Legal remedies

If the authority does not grant the permit or you want to take action against the permit, you can file a lawsuit

Legal basis

• §§ 12 para. 1 No. 4, 13, 15 of the law on protection against the harmful effects of ionizing radiation (StrlSchG )


• § 13 law for protection against the harmful effects of ionizing radiation (radiation protection law - StrlSchG)


• § 15 law for protection against the harmful effects of ionizing radiation (radiation protection law - StrlSchG)


• § 19 law for protection against the harmful effects of ionizing radiation (Radiation Protection Act - StrlSchG)

With the approval for a mobile veterinary X-ray facility, you can put the facility into operation or change it significantly in accordance with the approval.
Before you receive a permit, the competent authority will check whether you have submitted all the necessary documents and whether the legal requirements for the granting of the permit are met.
Please note that the approval also refers to the person(s) named as radiation protection officer. If there are changes in this area, these must also be communicated to the authority.
An example of other significant changes is the change of the image receiver of the approved X-ray facility.