Source: BUS Sachsen-Anhalt (Linie6PLus)

Applying for approval for the operation or significant modification of mobile X-ray equipment in veterinary medicine

Description

You require a corresponding permit to operate or significantly change the operation of technical X-ray equipment that requires a permit. Before you receive the permit, the authorities will check the legal requirements and the documents submitted.

Prerequisites

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

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 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.

radiation protection officer is not required, one of the aforementioned natural persons has the necessary expertise in radiation protection,
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,
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,
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,
there are no facts giving rise to doubts as to whether the personnel required to carry out the activity safely are available,
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,
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
other provisions of public law do not conflict with this.

Required documents

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,

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

Notification / application for approval in accordance with the Radiation Protection Act (StrlSchG)

Procedure

As the operator of an X-ray machine, you must apply for approval for operation or for a significant change.
If it is a construction procedure, it may be advisable 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.