Devices containing radioactive substances and equipment for the generation of ionizing radiation; application for type approval

If you want to manufacture devices containing radioactive substances or equipment for the generation of ionizing radiation that may be operated without a permit or notification, you can apply for a design approval.

Description

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

  • Required document/s

    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

Forms

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.

Status:19.12.2022

Responsible for editing:Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz

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