Information - Services - Formalities by subjects - Equipment, goods and materials - Plant operation and testing - Devices containing radioactive substances and equipment for the generation of ionizing radiation; application for type approval - Dienstleistungsportal Bayern

Description

The Federal Office for Radiation Protection (BfS) is responsible for issuing type approvals for devices containing radioactive substances and systems for generating ionizing radiation. If you acquire a type approval for a device or installation, you can use it without a permit or notification.

By issuing the type approval, the BfS confirms that the tested type meets the legal requirements for radiation protection. The type approval covers the entire design. No further special approval or testing is required for individual devices.

You submit your application for type approval for devices in which radioactive substances are inserted as well as for systems for the generation of ionizing radiation to the BfS.

Note:
The BfS grants type approval for a maximum of 10 years. Upon application, you can have a granted type approval extended.

Prerequisites

Applications for approval may be submitted by:

• Legal persons who place a device or plant on the market in Germany
  • Manufacturer or
  • Persons and organizations that supply the device or system to Germany or have it supplied to them.

Further requirements:

• They must ensure by means of a quality control that only devices are manufactured or shipped to Germany that correspond to the type tested
• The quality control must be supervised by an expert.

Procedure

You must submit the application for type approval in writing to the Federal Office for Radiation Protection (BfS).

• You download the application forms from the BfS website and fill them out.
• You must select one or more experts to supervise the quality control. Experts are persons who have knowledge and experience in radiation protection as well as knowledge of the design and construction of the device in question. They may belong to the company itself or to other companies (e.g. TÜV) and must be independent in the performance of their duties. Experts monitor that no device is placed on the market whose design deviates from the desired approval. You must inform the BfS of the experts and their qualifications when submitting the application.
• You send the completed and signed application forms together with the other required documents to the BfS by mail, fax or e-mail. You can send further documents by e-mail or also via a filetransfer portal.The BfS will check your application. For devices containing radioactive substances, the Federal Institute for Materials Research and Testing (BAM) is involved.
• If all requirements are met, the BfS issues the type approval and issues a type mark. The approval certificate and the determination of the experts will be sent to you by mail with a notice from the BfS.

Deadlines

none

Processing time

within 12 months

Required documents

• Erforderliche Unterlage/n

  Bei der Antragstellung müssen Sie einreichen:

  • Beschreibung der Bauart der Vorrichtung und deren Anwendung
  • Zeichnungen (Zusammenstellungen, gegebenenfalls Explosionszeichnungen) mit zugehörigen Werkstoffspezifikationen insbesondere zu Abschirmungen und Quellenhalterungen
  • Angaben zum Strahler, insbesondere Zeichnungen des Strahlers und Angaben zur Strahlenklassifikation gemäß DIN EN ISO 2919, Zertifikate beziehungsweise Angaben zum UKP-Laser mit Leistungsdaten
  • Angaben zu zulässigen Betriebsbedingungen und der vorgesehenen Dauer der Nutzung
  • Betriebsanleitung in deutscher Sprache
  • Konzept der Qualitätskontrolle
  • Rücknahmekonzept
  • aktueller Handelsregisterauszug
  • Führungszeugnis zur Vorlage bei Behörden von den Personen, die den Antragsteller vertreten (zum Beispiel Geschäftsführung)
  • Nachweis über Qualifikation des technischen Leiters der Herstellung
  • Nachweis über Qualifikation der zu benennenden Sachverständigen für die Qualitätskontrolle bei der Herstellung
  • Formblatt zu administrativen Angaben
  • je nach Antrag: Formblatt für Vorrichtungen oder Formblatt für Anlagen

Forms

• Form, Bavaria-wide: Formblatt zu technischen Angaben für Vorrichtungen, in die radioaktive Stoffe eingefügt sind

  Please note

  This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

• Form, Bavaria-wide: Formblatt zu technischen Angaben für Anlagen zur Erzeugung ionisierender Strahlung

  Please note

  This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

• Form, Bavaria-wide: Antrag auf Bauartzulassung für Vorrichtungen, in die radioaktive Stoffe eingefügt sind, sowie für Anlagen zur Erzeugung ionisierender Strahlung

  Please note

  This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

• Form, Bavaria-wide: Formblatt zu administrativen Angaben

  Please note

  This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

Fees

• The Federal Office for Radiation Protection (BfS) and, if applicable, the Federal Institute for Materials Research and Testing (BAM) charge costs for processing your application for type approval.

  • BfS: between EUR 2,000 and EUR 9,000, depending on the effort involved
  • BAM: between EUR 1,000 and EUR 3,000, depending on the effort involved

  
  In case of special requirements, an advance payment may be requested.

Legal bases

• §§ 45 – 49 Gesetz zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (Strahlenschutzgesetz – StrlSchG)
• §§ 16, 17, 24 - 26 Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (Strahlenschutzverordnung – StrlSchV)

Links to more information

• Allgemeine Informationen zum Verfahren auf der Internetseite des Bundesamts für Strahlenschutz
• Vorschlag der Strahlenschutzkommission für Anforderungen an die Bauartzulassung von Vorrichtungen, in die radioaktive Stoffe eingefügt sind, auf der Internetseite des Bundesamts für Strahlenschutz
• Angaben zur Bestimmung des Sachverständigen zur Überwachung der Qualitätskontrolle auf der Internetseite des Bundesamts für Strahlenschutz