Source: BUS Sachsen-Anhalt (Linie6Plus)

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

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.

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

Prerequisites

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

Required documents

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

Fees (costs)

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.

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.