Betrieb einer Röntgeneinrichtung oder wesentliche Änderung des Betriebs Erteilung

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

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

Before you receive a permit, the competent authority will check whether you have submitted all the necessary documents and whether the legal requirements for granting the permit are met.

Please note that the permit relates to the person named as the radiation protection officer. If there are any 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.

§ 16 StrlSchG: Documents required for the application for licenses pursuant to § 12 paragraph 1 number 4

1. plans, drawings and descriptions which are necessary for the examination of the licensing requirements

2. information which 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 powers necessary for the performance of their duties
b) it is ensured that the equipment is available and measures have been taken that are necessary according to the state of the art to ensure compliance with the protection regulations,

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 statutory order pursuant to Section 73, if the issue of a radiation protection instruction is required,

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 of these certificates

In the case of approval of equipment for use on animals, a license or proof of temporary exercise of the medical profession must also be submitted in accordance with § 15 StrlSchG.

The license is granted if the statutory licensing requirements pursuant to Sections 13 and 15 StrlSchG are met.

These are fulfilled if:

1. there are no facts that give rise to concerns about the reliability of the applicant, his legal representative or, in the case of legal persons or associations of persons without legal capacity, the persons authorized to represent or manage the company 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. other regulations under public law do not conflict with this
3. it is not an unjustified type of activity in accordance with a statutory instrument 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
4. it is ensured that the equipment is available and the measures have been taken which, in the case of an activity pursuant to Section 12 (1) No. 4, are necessary according to the state of the art in order to comply with the safety regulations,
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 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,
7. 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,
8. 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,
9. Furthermore, they have a license to practice medicine or a temporary authorization to practice medicine in accordance with § 15 StrlSchG.

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.

2 to 6 weeks

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

If the authority does not grant the permit or you wish to take legal action against the permit, you can file a complaint.

• 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 a notification in accordance with Section 19 (1) is sufficient, even taking into account the need for approval in accordance with Section 19 (2)

Responsible: LAVG

State Office for Occupational Safety, Consumer Protection and Health (LAVG)

Forms available: No

Written form required: Yes

Informal application possible: Yes

Personal appearance necessary: No