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

Service Description

The Federal Office for Radiation Protection (BfS) is responsible for issuing type approvals for devices with radioactive substances and systems for generating ionizing radiation. If you obtain a type approval for a device or system, you can use it without approval 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 type. No special approval or testing is required for individual devices.

You submit your application for type approval for devices in which radioactive substances are inserted and for systems for generating ionizing radiation to the BfS.

Note:
The BfS issues the type approval for a maximum of 10 years. You can apply to have a type approval extended.

Process flow

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.

Requirements

Applications for admission 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

Which documents are required?

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

What are the 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 expenditure


An advance payment may be required under special circumstances.

What deadlines do I have to pay attention to?

none

Processing duration

within 12 months

Legal basis

Appeal

Further Information

Author

Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU)

Professionally released on

01.09.2020

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

Competent Authority

Bundesamt für Strahlenschutz (BfS)

Postal address
Post office box 10 01 49
38201 Salzgitter

Address
Willy-Brandt-Straße 5
38226 Salzgitter
Telephone
+49 30 18333-0
Fax
+49 30 18333-1885
E-Mail
Contact us
WWW
Website of the Federal Office for Radiation Protection
DE-Mail
epost@bfs.de-mail.de

Further Authorities

Bundesamt für Strahlenschutz (BfS), Bauartzulassungen
Postal address
Post office box 100149
38201 Salzgitter
Telephone
+49 30 183331410
Fax
+49 30 183331415
E-Mail
Contact us