Apply for approval of the design for devices containing radioactive substances and installations for the production of ionising radiation
Description
The Federal Office for Radiation Protection (BfS) is responsible for issuing type approvals for devices containing radioactive substances and systems for the generation of ionising radiation. If you purchase a type approval for a device or plant, you can use it without a permit or display.
By granting type approval, the BfS confirms that the tested types meet 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 as well as for systems for the generation of ionising radiation to the BfS.
Hint:
The BfS grants type approval for a maximum of 10 years. Upon request, you can have a type approval granted extended.
Applications for admission can be submitted by:
- legal persons placing a device or installation on the market in Germany
- Manufacturer or
- Persons and organisations who deliver the device or plant to Germany or have it delivered
Further requirements:
- You must ensure with a quality control that only devices are manufactured or brought to Germany that correspond to the tested type
- Quality control must be monitored by an expert
When applying, you must submit:
- Description of the design of the device and its application
- Drawings (compilations, exploded drawings, if necessary) with associated material specifications, in particular for shields and source brackets
- Information on the radiator, in particular drawings of the radiator and information on the radiation classification according to 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
- Concept of quality control
- Take-back concept
- Current excerpt from the commercial register
- Certificate of good conduct for submission to authorities by the persons representing the applicant (e.g. management)
- Proof of qualification of the technical manager of the production
- Proof of qualification of the experts to be appointed for quality control during production
- Administrative information form
- depending on the application: form for devices or form for attachments
The Federal Office for Radiation Protection (BfS) and, if applicable, the Federal Institute for Materials Research and Testing (BAM) will charge costs for processing your application for type approval.
- BfS: between EUR 2,000 and EUR 9,000, depending on expenditure
- BAM: between 1,000 EUR and 3,000 EUR, depending on the effort
In case of special conditions, an advance payment may be required.
within 12 months
- Application for type approval for devices incorporating radioactive substances and for installations for the production of ionising radiation
- Administrative information form
- Technical information form for devices containing radioactive substances
- Technical information form for installations producing ionising radiation
You must submit the application for type approval in writing to the Federal Office for Radiation Protection (BfS).
- You download the application forms on the BfS website and fill them out.
- You must select one or more experts to oversee quality control. Experts are persons who have knowledge and experience in radiation protection as well as knowledge of the structure and construction of the device concerned. They can belong to their own or other companies (e.B. TÜV) and must be independent in the exercise of their activities. Experts shall 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 can send the completed and signed application forms 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 filetransfer portal. The BfS will examine your application. The Federal Institute for Materials Research and Testing (BAM) is involved in devices containing radioactive substances.
- If all requirements are met, the BfS issues type approval and assigns a type mark. The admission certificate and the designation of the experts will be sent to you by the BfS by post with a notification.
Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU)
The text was automatically translated based on the German content.
