Documents to be submitted to the Federal Institute for Materials Research and Testing (BAM)

For an application for a type approval for devices containing radioactive substances the following documents have to be submitted in order to be presented to the Federal Institute for Materials Research and Testing (BAM) to carry out type testing:

• description of the type of device and its application,
• drawings (i.e. compilations) of the device including material specifications,
• specifications and drawings of the radioactive source, source classification according to DIN EN ISO 2919, certificates,
• intended working life and ambient restrictions,
• documents concerning the quality assurance of the manufacturing procedures of the source and the device according to annex 3 of the Proposal of the German Radiation Protection Commission (SSK) concerning requirements for the type approval of devices containing radioactive substances.