Type approval procedure for devices containing radioactive substances and for accelerators - Additional information

Legal basis

The type approval procedure for devices containing radioactive substances or accelerators is regulated by §§ 45 - 48 of the "law for reorganizing regulations concerning the safety against the hazards of ionizing radiation" (Recht zum Schutz vor der schädlichen Wirkung ionisierender Strahlung - Strahlenschutzgesetz – StrlSchG) together with §§ 16, 17, 24, 25 and 26 of the "Ordinance on the Protection against Damage and Injuries Caused by Ionizing Radiation" (Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung - Strahlenschutzverordnung - StrlSchV).

In general, § 12 (1) no. 1 StrlSchG the handling of "other radioactive substances" requires an authorization, which is granted by the Federal States’ authorities responsible for executing the legislation on radiation protection.

However, according to § 5 (1) together with Annex 3 part A no. 4 StrlSchV type-approved devices do not require an authorisation. Such devices may be operated without license or notification. Please note, that this exception applies for the use and does not apply for installation, disassembly and maintenance of these devices. The storage of type-approved devices is also subject to restricting regulations acc, to Annex 3 part B no. 5 StrlSchV. Additionally, type-approved accelerators can also be operated without license or notification acc. to Annex 3 part C no. 1 StrlSchV.

Type-approved devices fulfil sophisticated technical requirements - thus, a high level of radiation protection is ensured whilst the use of such devices. The type approval covers the entire type, which means, that any individual device does not require specific testing or licensing by another German authority.

According to § 185 (1) no. 4 StrlSchG the Federal Office for Radiation Protection (BfS) is the competent authority for granting type approvals. By granting a type approval the competent authority confirms that the essential radiation protection features of the tested prototypes comply with the requirements laid down in §§ 45 - 48 StrlSchG in connection with §§ 16, 17, 24, 25 and 26 StrlSchV.

These requirements comprise

• the limitation of the activity of the contained radioactive substance,
• the limitation of the dose rate of at a distance of 10 cm from the surface of the device,
• the tightness of the radioactive source,
• further constructive requirements and
• a concept for the disposal or recycling of the device.

Accelerators have to comply with the limitation of the dose rate at a distance of 1 µSv/h at 10 cm from the surface of the accelerator.

Type approval procedure

Either the manufacturer or the distributor of the device or accelerator can apply for a type approval. Once BfS has received the application documents, BfS proves whether the device is qualified for a type approval procedure, in particular with respect to its characteristics relevant for radiation protection. When the entire application documents have been submitted, BfS performs the type testing. In case of devices containing radioactive sources, the BfS involves the Federal Institute for Materials Research and Testing (BAM) for an assessment of the tightness, the material and design of the device as well as for the evaluation of the quality assurance. The applicant submits the relevant prototypes to the testing authorities, as requested.

Finally, BfS evaluates the results of the type testing procedure. If the device or accelerator complies with all requirements, the BfS grants the type approval and assigns a type approval number. Acc. to § 46 (6) StrlSchG an application file shall be completed within twelve months after the entire relevant documents or the prototype have been submitted.

Persons in charge

Depending on the application, either the manufacturer or the distributor as a legal entity holds the type approval of the device or the accelerator. A type approval can only be granted if there are no concerns as to the reliability of the applicant. This will be proved by submitting a current excerpt from the commercial register and the Certificate of good conduct from the company manager to be presented to public authorities pursuant to § 30 (5) of the Federal Central Register Act.

The manufacturer has to designate a person who is in charge of the technical management of production and who has sufficient technical competence. His/her competence shall be verified by the specification of his/her area of responsibility and by his/her qualification for the task.

Quality control and qualified expert (§ 24 (1) no. 1 - 3 StrlSchV)

The holder of the type approval shall ensure by means of quality control that only devices, which comply with the requirements according to the granted type approval, are put into circulation. The relevant concept concerning the quality control shall be submitted to BfS.

The quality control procedures implemented at the holder of the type approval shall be supervised by a qualified expert who will be appointed by the BfS. Quality control shall be supervised independently and free of instructions from any superior. In order to appoint a qualified expert, the applicant shall designate one or several persons considered to be qualified for this task.

If the type approval holder is the manufacturer of the device, it is recommended to designate a staff member of the manufacturer as qualified expert.

If the type approval holder is the distributor of the device, the qualified expert may be

• a qualified member of staff of the distributor or
• an external expert (e.g. a member of staff of the manufacturer's or an independent expert pursuant to § 172 StrlSchV).

BfS has to be informed about the name of the qualified expert, his/her area of responsibility and his/her qualification. In case that the qualified expert shall be exchanged or further persons shall be appointed as qualified experts the BfS has to be informed in due time in order to reassign the responsibilities.

Requirements concerning the application documents

The application documents required for a type approval for devices containing radioactive substances or accelerators must contain the necessary administrative and technical information. During the type testing procedure for devices containing radioactive substances, the Federal Institute for Materials Research and Testing (BAM) may require further documentation, which will be requested directly from the applicant.

Together with the application for type approval, the following documents have to be submitted to BfS:

Administrative details form in single copy

• References provided by the applicant (i.e. manufacturer or distributor), e.g. an excerpt from the commercial register or the "Handling licence for radioactive substances" issued by the competent State authority
• Certificate of good conduct pursuant to § 30 (5) of the Federal Central Register Act issued for the representative of the applicant (e.g. Managing Director)
• Name and details on the experience of the person, that is in charge of the technical management of production
• A relevant concept concerning the quality control with name and details of the designated qualified expert for supervising the quality control
• A concept for the disposal or recycling of the device

Technical details form in duplicate:

• Type/Model, purpose or utilization of the device
• Description of operating principle, construction characteristics and the essential radiation protection features of the device
• Details on quality assurance within the manufacturing process (e.g. certificate acc. to ISO 9001), quality concept
• Technical documentation and drawings, details on design, dimensions and material of the essential radiation protection features
• Existing certificates (e.g. from countries outside Germany)
• Operating instructions (manual) in German language containing information about the radiation protection measures and their operating conditions
• Details on the intended terms of use, ambient conditions, maintenance instructions and specific service notes (if applicable)
• In case of devices containing radioactive substances further information is required concerning the radioactive source: maximum activity, chemical and physical characteristics of the radionuclide, design and material of the enclosing, mounting of the radioactive source, model and name of manufacturer, Source Certificate (if available), as well as details on the safety system in place

Special requirements:

1. Requirements concerning anti-theft protection of ionization smoke detectors: It must be possible to fix ionization smoke detectors in such a way that they can only be removed with the help of special tools; e.g. the access to the radioactive source must be prevented by sealing relevant screws
2. Requirements concerning maintenance: It must be ensured that the installation, disassembly and maintenance of the type-approved device must not be performed by the owner but has to be performed by the manufacturer or by authorised and trained personnel (i.e. persons with sufficient technical experience and the authorization required) only.
3. Requirements concerning leakage tests: Generally, leakage tests – with the exception of the leakage test carried out by the manufacturer – are not required if the radioactive source used in the device has an ISO classification, that complies with at least DIN EN ISO 2919 Table 3. If further details are required, the BAM will request more information from the applicant.

Type approval modifications

Technical modifications .of the type-approved device, especially concerning the features relevant for radiation protection, require an amendment to the approval certificate, which must be applied for at the BfS

The applicant shall submit documents to BfS which contain the description of the entire intended modifications with respect to the essential radiation protection features, together with a free form application for a modification of the type approval. In case drawings are submitted, these shall comply with the relevant standards for technical documentation. The relevant documents will be verified by BfS. In case of modifications relevant to radiation protection BfS may require another type testing and may involve the BAM too. The applicant provides the relevant prototypes to the testing authorities if requested.

BfS shall be informed immediately about changes of the type approval holder’s trade name, the manufacturer, the persons in charge etc. by submitting relevant documents (e.g. excerpt from the commercial register or proof of qualification).

If the requirements are fulfilled, an amendment to the approval certificate will be granted. A corresponding procedure will be performed in case of the application of an extension of the type approval (see Questions and Answers).

Limitation and extension of type approvals

According to § 46 (5) StrlSchG the type approval is granted for a maximum period of ten years. This approval period may be extended on request. A free form application for an extension of the type approval shall be submitted at least three months before the type approval expires.

Forms on administrative and technical details and current versions of the relevant drawings of the device (in duplicate) shall be enclosed.

In case of an application for extension of the type approval it has to be verified that the device conforms to the state of the art technical requirements. The BfS may require another type testing and may involve the BAM too. The applicant provides the relevant prototypes to the testing authorities if requested.

If the requirements are fulfilled, an amendment to the approval certificate concerning the expiry date will be granted..

Costs

All costs related to granting, amending and extending a type approval shall be borne by the applicant according to § 21 (1) no. 4 of the German Atomic Energy Law (AtG).

The costs – fees and expenses – will be determined separately by BfS and BAM according to their relevant scale of fees. Foreign applicants who have not been in contact with the BfS before may be required to provide reasonable financial security in advance. The same procedure may apply for German applicants who did not pay their debts or who have paid their debts with a significant delay in the past.