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
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.
Processing time
within 12 months
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.
Links to more information
Status:19.12.2022
Responsible for editing:Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz
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