Type approval procedure pursuant to the German Radiation Protection Ordinance (StrlSchV)
- Supplementary information on the application

Legal basis

The type approval procedure for equipment and devices in which radioactive substances are inserted is regulated by §§ 25 to 27 together with Annex V of the “Ordinance on the Protection against Damage and Injuries Caused by Ionizing Radiation” (Radiation Protection Ordinance – StrlSchV).

In general, § 7 (1) StrlSchV stipulates the requirement of authorization for the handling of “other radioactive substances”. Authorization is granted by the Federal States’ authorities responsible for the execution of the Radiation Protection Ordinance.

However, the Radiation Protection Ordinance permits exceptions to this general rule in the case of type-approved devices. Such devices may be operated without license or notification. The exception does not apply to installation, disassembly and maintenance of these devices. The storage of type-approved devices is also subject to restricting regulations (§ 8 (1) in connection with Annex I part B no. 4 and 5).

Type-approved devices are characterised by a high level of radiation protection which is ensured for the handling and use of such devices. The type approval covers the entire type, i.e. the individual device does not require specific testing or licensing by the competent authority of the Federal state..

According to the Radiation Protection Ordinance, the Federal Office for Radiation Protection (BfS) is the competent authority for granting type approvals. In 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 §§ 25 and 26 in connection with Annex V StrlSchV. These requirements relate to the activity of the inserted radioactive substance and the local dose rate in the vicinity of the device, the tightness of the radiation source and certain constructive requirements. A take-back concept must be presented describing where the devices will remain when they are no longer in use.

Type approval procedure

Either the manufacturer or the distributor of the device can apply for a type approval. Once BfS has received the written application documents, BfS assesses whether the device is eligible for type approval, in particular with respect to the radiation protection-relevant features. When all application documents have been submitted, BfS performs the type testing. In this context, BfS consults the Federal Institute for Materials Research and Testing (BAM) for an assessment of the tightness, material selection and the design of the component enclosing the radioactive substance as well as for an evaluation of quality assurance aspects. The applicant submits the relevant prototypes to the testing authorities, as requested.

BfS evaluates the results of the type testing procedure. If all requirements are complied with, BfS grants the type approval and awards a type approval label.

Persons in charge

Depending on the application, either the manufacturer or the distributor of the devices holds the type approval as legal entity. A type approval can only be granted if there are no concerns as to the reliability of the applicant. To this end, proof must be furnished in the form of a current excerpt from the commercial register and the company managers’ Certificates of good conduct to be presented to public authorities pursuant to § 30 (5) of the Federal Central Register Act.

The manufacturer shall designate a person who is in charge of the technical management of production and whose technical competence must be indisputable. Such competence shall be confirmed by designating the individual’s area of responsibility and by furnishing proof of his/her qualification for this task.

Quality control and qualified expert (§ 27 (1) no. 1 and 2 StrlSchV)

The type approval holder shall ensure by means of quality control that only devices conforming to the granted type approval are put into circulation. The quality control concept shall be submitted to BfS.

Such quality control shall be supervised by a qualified expert to be appointed by BfS. Quality control shall be supervised independently and free of instructions from superiors. For the appointment of a qualified expert, the applicant shall designate one or several persons considered apt for this task.

If the type approval holder is the manufacturer of the device, a staff member of the manufacturer is generally appointed 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 § 66 StrlSchV).

BfS shall be informed of the relevant expert’s name, area of responsibility and qualification. In the event that a different person or further persons shall be appointed as qualified expert(s) BfS shall be informed in due time in order to reassign the responsibilities.

Requirements of the application documents

The application documents required for a type approval pursuant to StrlSchV must comply with the requirements set out in Annex V part C StrlSchV and must contain the necessary administrative and technical information. During the type testing process, the Federal Institute for Materials Research and Testing (BAM) may require further documentation. In this case the applicant will be requested to submit such documents.

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. a copy of an excerpt from the commercial register or the “Handling licence for radioactive substances” (Genehmigung zum Umgang mit radioaktiven Stoffen) issued by the competent Federal State authority
• Certificate of good conduct pursuant to § 30 (5) of the Federal Central Register Act issued for the individual representing the applicant (e.g. manager)
• Name and details on the technical experience of the person in charge of the technical management of production
• Quality control concept, designated qualified expert for supervising quality control
• Description of the take-back concept

Technical details form in duplicate:

• Type designation, purpose of use of the device
• Description of construction and operating principle of the device, constructive features, presentation of the essential radiation protection features
• Details on the inserted radioactive substance: maximum activity, chemical and physical quality, nature and material of the component enclosing the radioactive substance, method of fastening the radioactive source to its mount
• Type and manufacturer of the radioactive source, certificate (ISO 9001 classification)
• Details on quality assurance in the manufacturing process
• Details on the restriction of access to the radiation source in the assembly
• Technical documentation and drawings, details on design, dimensions and material of the essential radiation protection features
• Copies of existing certificates (e.g. from countries outside Germany)
• Operating instructions (manual) in German language containing reference to the radiation protection measures and conditions
• Details on the intended term of use, ambient conditions, intended operational demands and special service notes (if applicable)
• Proof confirming the existence of a quality assurance programme (Annex V part A no. 5 StrlSchV) for examination by BAM. (certificate or further documents on confirmation of ISO 9001:2008)

Technical notes:

1. Anti-theft protection: 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; access to the radiation source must e.g. be constricted by sealing the relevant screws.
2. Service notes: It must be ensured that the acquirer of the type-approved device will commission only the manufacturer or authorised and trained personnel (i.e. individuals with the necessary expertise and the required authorization) with the installation, disassembly and maintenance of the device as well as with repairs and service.
3. Leakage tests – with the exception of the acceptance test carried out by the manufacturer – will generally not be required if the radioactive sources used in the device have at least an ISO classification according to DIN ISO 2919 Table 3. In the event that further details are required in this context, BAM will request the applicant to provide the necessary information.

Type approval modifications

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

The applicant shall submit documents to BfS which contain a complete and unambiguous description of the planned modifications with respect to the essential radiation protection features, together with a free-form application for a type approval modification. In the event that drawings are submitted, these shall comply with the applicable standards for technical documentation. The relevant documents shall be presented to BfS for verification.

BfS shall also be immediately informed of 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, the approval certificate will be amended.

Limitation and extension of type approvals

The type approval is granted for a maximum period of ten years. This approval period may be extended on request.

The free-form application for an extension of the type approval shall be submitted at least three months before expiration of the approval period. The forms on administrative and technical details of the device shall be enclosed. An updated version of the drawings used for type approval shall also be enclosed (in duplicate).

In the case of an application for an extension of the type approval it has to be verified that the device conforms to the state-of-the-art according to the legal regulations valid at the time of the application. Further fundamental type tests involving BAM may be required.

If the requirements are fulfilled, the approval authority will grant an extension of the type approval.

The type approval becomes invalid with expiration of the approval period. A new type approval can only be granted after passing another type approval procedure.

Costs

The costs arising in connection with granting, changing and extending type approvals (according to § 21 (1) no. 4 of the German Atomic Energy Law – AtG) shall be borne by the applicant. The costs – fees and expenses – will be determined separately by BfS and BAM according to the applicable scales of fees. Applicants having their registered office outside Germany who have not been in contact with the competent authorities before may be required to provide reasonable financial security in advance. The same may be required of German applicants who paid their debts with a significant delay in the past or even did not pay their debts.