Source: BUS Sachsen-Anhalt (Linie6PLus)

Application for type approval for devices containing radioactive substances and installations for the generation 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 generating ionising radiation. If you acquire a type approval for a device or installation, you can use it without a permit or notification.

With the granting of 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 facilities for the generation of ionising radiation to the BfS.

Notice:
The BfS grants the design approval for a maximum of 10 years. Upon application, you can have a granted design approval extended.

Prerequisites

Applications for approval may be submitted by

Legal persons who place a device or system on the market in Germany
- manufacturers or
- Persons and organisations who supply the device or system to Germany or have it supplied to them.

Further requirements:

They must guarantee by means of a quality control that only devices are manufactured or brought into Germany which correspond to the tested type.
The quality control must be supervised by an expert.

Required documents

When applying, you must submit:

Description of the design of the device and its application
Drawings (compilations, exploded views if applicable) with associated material specifications, in particular for shielding and source supports
Information on the emitter, in particular drawings of the emitter and information on the radiation classification in accordance with DIN EN ISO 2919, certificates or information on the UKP laser with performance data
information on permissible operating conditions and the intended duration of use
Operating instructions in German language
Quality control concept
take-back concept
current excerpt from the commercial register
Certificate of good conduct for presentation to the authorities from 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 in production
Form for administrative data
depending on the application: form for devices or form for plants

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 the effort involved

In case of special requirements, an advance payment may be requested.

You download the application forms from the BfS website and fill them out.
You must select one or more authorised 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 to other companies (e.g. TÜV) and must be independent in the performance of their activities. 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 by post, fax or e-mail to the BfS. Further documents can be sent by e-mail or via a filetransfer portal.The BfS will check your application. In the case of 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 awards 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.