Source: BUS Sachsen-Anhalt (Linie6PLus)

Apply for a permit to operate an X-ray facility or make a significant change to the operation of teleradiology

Description

With the permit, you may put a teleradiological X-ray facility into operation or significantly modify 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 staff of radiation protection officers must also be reported again. Examples of other significant changes include:

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

Requirements

Approval will be granted to you if the respective requirements are met. The conditions are fulfilled if:

there are no facts from which doubts arise as to the reliability of the applicant, his or her legal representative or, in the case of legal persons or associations of persons without legal capacity, the persons 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, one of the natural persons mentioned has the necessary expertise in the field of radiation. possesses radiation protection,
there are no facts that give rise to doubts about the reliability of the radiation protection officers and that 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 powers necessary for the performance of 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 that give rise to doubts as to the availability of the personnel necessary for the safe performance of the activity,
it is ensured that the equipment is available and that the measures have been taken which, in the case of an activity pursuant to § 12 (1) number 4, are necessary according to the state of the art to ensure that the protective regulations are complied with,
it is not an unjustified type of activity according to a statutory ordinance pursuant to § 6 (3) or if, taking into account a report published pursuant to § 7 (2), there are no significant doubts as to the justification of the type of activity, and
do not conflict with other provisions of public law.

Which documents are required?

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

1. plans, drawings and descriptions necessary for the examination of the conditions for approval;

2. Information enabling it to be verified whether:
(a) the number of radiation protection officers necessary for the safe performance of the activity has been appointed and they have been granted the powers necessary for the performance of their duties;
(b) it is ensured that the equipment is in place and that measures are taken which are necessary in accordance with the state of the art to ensure compliance with the protective requirements;

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 the issuance of a radiation protection instruction is required,

i.e. in particular:

Proof of expertise in radiation protection incl. update certificate
Certificate and test report on radiation protection testing of the apparatus by an expert or an expert organization
Type approval certificate with routine test confirmation or CE certificate of conformity
Proof of knowledge in radiation protection of the personnel deployed, including updates of these certificates

As an operator of an X-ray machine, you must apply for a permit to operate it or for a significant modification.
If it is a construction process, 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. It may happen that documents are requested.
Permission will be given to you in writing.