Strahlenschutz, Genehmigung zum Betrieb einer Anlage zur Erzeugung ionisierender Strahlung beantragen

• § 10 Strahlenschutzgesetz (StrlSchG) –Genehmigungsbedürftige Errichtung von Anlagen zur Erzeugung ionisierender Strahlung
• § 12 StrlSchG – Genehmigungsbedürftige Tätigkeiten
• § 13 StrlSchG – Allgemeine Voraussetzungen für die Erteilung der Genehmigung; Aussetzung des Genehmigungsverfahrens
• § 14 StrlSchG – Besondere Voraussetzungen bei Tätigkeiten im Zusammenhang mit der Anwendung am Menschen
• § 15 StrlSchG – Besondere Voraussetzungen bei Tätigkeiten im Zusammenhang mit der Anwendung am Tier in der Tierheilkunde
• § 17 Absatz 1 Satz 1 StrlSchG – Anzeigebedürftiger Betrieb von Anlagen zur Erzeugung ionisierender Strahlung
• Anlage 2 zu § 16, § 25 Absatz 2, § 40 Absatz 4, § 46 Absatz 1 StrlSchG – Erforderliche Unterlagen zur Prüfung von Genehmigungsanträgen
• Merkposten zu Antragsunterlagen in den Genehmigungsverfahren für Anlagen zur Erzeugung ionisierender Strahlen nach § 11 Abs. 1 und 2 StrlSchV
• Strahlenschutzverordnung (StrlSchV)
• Verwaltungskostengesetz des Freistaates Sachsen (SächsVwKG)
• Sächsisches Kostenverzeichnis (SächsKVZ) – Nr. 87

If you want to operate an installation for the generation of ionising radiation, you either need a permit or you must submit a notification, or you may operate the installation without a permit and notification. This depends on the technical and physical parameters of the installation.

Systems for generating ionising radiation are devices that can generate particle or photon radiation with an energy of at least five kiloelectronvolts. These include

• Electron accelerators,
• Ion accelerators,
• Plasma systems and
• Laser systems, in particular ultrashort pulse lasers.

No authorisation or notification is required in the following special cases:

• Your system for generating ionising radiation has a type approval or
• the potential difference is no more than 30 kilovolts and the local dose rate at a distance of 0.1 metres from the touchable surface of the system is no more than one microsievert per hour or
• in the case of a laser system: the irradiance of the laser radiation is no more than one E13 watt per square centimetre and the local dose rate at a distance of 0.1 metres from the touchable surface of the system is no more than one microsievert per hour.

You do not need a licence to operate the following equipment, but must submit a notification:

• Plasma equipment whose operation does not exceed the local dose rate of ten microsieverts per hour at a distance of 0.1 metres from the walls of the area that is inaccessible during operation for electrotechnical reasons, or
• Ion accelerators whose operation does not exceed the local dose rate of ten microsieverts per hour at a distance of 0.1 metres from the touchable surface.

You can find more detailed information on the notification in the corresponding service description here in Amt24 (see -> Further information).

If you wish to operate a system that does not fall under the above-mentioned categories, you must obtain a licence. In the application for a licence, you must prove that your planned operation is justified and safe.

Notes:

• Installations for the generation of ionising radiation are not permitted: X-ray equipment and interference emitters (see -> Further information), as well as nuclear facilities.
• In certain cases, you will need a licence under radiation protection law for the construction of an installation for the generation of ionising radiation. The criteria are listed in § 10 of the Radiation Protection Act (StrlSchG). Further information can be found in the corresponding service description here in Amt24 (see -> Further information).

• Application,
• Details of the person responsible for radiation protection and their authorised representative,
• Certificate of good conduct of document type O for the applicant or the person authorised to represent the applicant,
• Details of the facility for the generation of ionising radiation,
• if applicable, information on the handling and storage of dismantled activated system components,
• Description of the work processes and procedures,
• Details of the radiation protection officer, including proof of the necessary expertise in radiation protection,
• Details of other persons involved and necessary personnel, including proof of the necessary expertise or knowledge in radiation protection, if applicable,
• Estimates of occupational exposure and population exposure,
• Radiation protection instructions,
• safety report, if applicable,
• Documentation on rules of behaviour and measures in the event of accidents/incidents

For more information on the documents that you must submit with your application, please refer to the list of items to be included with the application (see -> Legal basis).

General authorisation requirements:

• There must be no facts that give rise to concerns about the reliability of the person obliged to notify.
• The activity must be justified.
• Appointment of radiation protection officers with the necessary expertise to fulfil the tasks and in sufficient numbers
• A sufficient number of personnel to carry out the activities safely
• Proof of state-of-the-art technology and measures to comply with the protection regulations

Additional special requirements for activities in connection with the use on humans:

• Licence to practise as a doctor or dentist (or authorisation to temporarily practise as a doctor or dentist)
• Ensuring the availability of medical physics experts in defined treatments in sufficient numbers
• Proof of ensuring the lowest possible exposure during examinations or the dose distribution required for the intended purposes during treatments
• Further requirements also apply to the authorisation for teleradiology.

Additional special requirements for activities in connection with the use on animals in veterinary medicine:

• Licence to practise as a veterinarian, doctor or dentist (or authorisation to temporarily practise as a veterinarian, doctor or dentist)

In principle, the applicant is obliged to obtain information on the applicable legal requirements in accordance with the Radiation Protection Act (StrlSchG).

Fee range: EUR 795.00 to EUR 18,813 (depending on expenses)

• Submit your application for a licence to operate an ionising radiation facility to the competent authority.
• The competent authority will check the application received and will address any questions or additional requirements to the contact person you have specified.
• If all requirements are met, the competent authority will send you the notification and the invoice to be paid by post.

at least 2 weeks

The processing time depends on the complexity of your system and the planned operation and on the completeness of the documents you submit.

none

The ionising radiation production facility is to be operated in Saxony. If you wish to apply for the mobile operation of a facility for the generation of ionising radiation, you must have your habitual residence in Saxony or your organisation must have its registered office in Saxony.

Objection (details in the notification)