Apply for type approval for devices with radioactive substances and systems for generating ionizing radiation

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 in.
• 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 their own or 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 required approval. You must inform the BfS of the experts and their qualifications when submitting the application.
• Send the completed and signed application forms together with the other required documents to the BfS by post, fax or e-mail. You can send further documents by e-mail or via a file transfer portal and the BfS will check your application. For devices containing radioactive substances, the Federal Institute for Materials Research and Testing (BAM) will be involved.
• If all requirements are met, the BfS issues the type approval and awards a type mark. The approval certificate and the designation of the experts will be sent to you by post with a notification from the BfS.

Applications for approval can be submitted by

• legal persons who place a device or system on the market in Germany
  • manufacturers or
  • Persons and organizations who deliver the device or system to Germany or have it delivered to Germany

Further requirements:

• You must carry out quality control to ensure that only devices that comply with the tested type are manufactured or shipped to Germany
• The quality control must be supervised by an expert

You must submit the following with your application

• Description of the design of the device and its application
• Drawings (compilations, possibly exploded views) with associated material specifications, in particular for shielding and source holders
• Information on the emitter, in particular drawings of the emitter and information on the beam classification in accordance with DIN EN ISO 2919, certificates or information on the USP laser with performance data
• Information on permissible operating conditions and the intended duration of use
• Operating instructions in German
• Quality control concept
• Return concept
• Current extract from the commercial register
• Certificate of good conduct for submission to the authorities by the persons representing the applicant (e.g. management)
• Proof of qualification of the technical production manager
• Proof of qualification of the experts to be appointed for quality control during production
• Form for administrative information
• Depending on the application: form for devices or form for systems

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 expenditure

An advance payment may be required under special circumstances.

none

within 12 months

• §§ 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)

• Antrag auf Bauartzulassung für Vorrichtungen, in die radioaktive Stoffe eingefügt sind, sowie für Anlagen zur Erzeugung ionisierender Strahlung
• Formblatt zu administrativen Angaben
• Formblatt zu technischen Angaben für Vorrichtungen, in die radioaktive Stoffe eingefügt sind
• Formblatt zu technischen Angaben für Anlagen zur Erzeugung ionisierender Strahlung

The text was automatically translated based on the German content.