Devices or accelerators that have been granted a type approval may be used in a mainly professional context without a license and without a notification. Type approved devices are characterised by a high level of radiation protection for the operation of such devices. Regulatory control focuses on the approval of the entire type so that any individual device does not need to be approved or evaluated by the competent authorities of the Federal States.

It was considered by the International Atomic Organisation (IAEO), that devices bearing a low radiological risk should be released from regulatory control so that controls don’t have to be performed when they are not necessary. This principle has been implemented in § 5 together with Annex 3 part A and B StrlSchV in order to allow for the handling of devices without authorization. According to these provisions, radioactive sources may be handled without licensing if the source activity does not exceed the exemption limits set out in Annex 4, Table 1, Column 2. The exemption limit reflects a certain level of activity below which the radiological risk arising from the handling of the radioactive source is negligible.

If a radioactive source with an activity above the exemption limit is enclosed and inserted into a device and the radiological risk arising from the handling of this device is negligible because of the specific design of the device, the device may also be released from regulatory control by granting a type approval. An essential element of the type approval procedure acc. to § 45 to 48 StrlSchG is to prove the relevant preconditions acc. to § 16 and § 17 StrlSchV by BfS as the competent authority.

The requirements in order to obtain a type approval for devices containing radioactive substances or for accelerators are set out in § 16 and § 17 of the Radiation Protection Ordinance (StrlSchV) in its current version – which conforms to the provisions of the EURATOM basic standard (Directive 2013/59/EURATOM as of 5^th of December 2013).

The preconditions for a type approval for devices containing radioactive substances are laid down in § 16 StrlSchV. Thus, the activity of the inserted radioactive substance is restricted to ten times of the exemption limit (at maximum). The radioactive substance must be enclosed and covered so that it cannot be touched. The ambient equivalent dose rate (local dose rate) at a distance of 10 cm from the surface must not exceed 1 µSv/h under standard operating conditions. Additionally, the applicant shall prove, that a reasonable, standard-based quality assurance system is established in the manufacturing process of the devices and the radioactive sources. This requirement should ensure that every single manufactured device complies with the approved type and that the quality remains constant. A concept must be presented describing how and where the device and/or the radioactive source will be disposed of when it is no longer used.

The preconditions for a type approval for accelerators are laid down in § 17 StrlSchV. Thus, the ambient equivalent dose rate (local dose rate) at a distance of 10 cm from the surface must not exceed 1 µSv/h under standard operating conditions.

According to § 185 (1) no. 4 StrlSchG the Federal Office for Radiation Protection (BfS) is responsible for granting type approvals for devices containing radioactive substances and for accelerators. Please send applications for type approvals together with the required form sheets to the following address:

Acc. to § 187 (1) no. 1 StrlSchG the Physikalisch-Technische Bundesanstalt (PTB) is responsible for type approvals for all kinds of x-ray devices since 2019. You can get more information at the corresponding website.

To the topic

• Details on the appointment of a qualified expert for supervising quality control according to § 24 no.1 to 3 StrlSchV
• Application form sheets
• Documents to be submitted to the Federal Institute for Materials Research and Testing (BAM)

Generally, the type tests will be performed by the BfS. Additionally, in case of devices with radioactive sources the Federal Institute for Materials Research and Testing (BAM) is consulted for an assessment of the tightness, material selection and the design of the device as well as for an evaluation of quality assurance aspects.

The applicant shall submit the relevant prototypes to the testing authorities upon request.

In some cases the BfS may accept exceptions from the general requirements set out in StrlSchV. However, the level of radiation protection must be ensured by design, material and function of the device nonetheless.

Under particular conditions a type approval might be granted for a device that contains a radioactive substance even if this substance is not tightly enclosed but is covered and non-touchable. This kind of exception is permitted, for example, for some ion mobility spectrometers. However, the design of the entire device must ensure, that the relevant tightness requirements are complied with.and the radioactive source itself must be protected from external influences and any potential damage (i.e. from corrosive gases).

BfS as competent authority for type approvals can schedule longer or shorter time intervals for the mandatory regular leakage tests of the radioactive source. Furthermore, a type approval might be granted even if the activity of the contained radioactive substance exceeds the tenfold of the exemption limit. However, a safe operation of the device concerning the radiation protection requirements must be guaranteed nonetheless.

Type approved devices must be designed so that no further leakage tests are necessary apart from the acceptance test carried out by the manufacturer and the mandatory leakage tests according to § 25 (4) StrlSchV, that have to be performed every ten years.

The applicant might be excepted from the obligation to perform leakage tests in case the tightness of the radioactive source is ensured – which must be verified by an expertise submitted by the Federal Institute for Materials Research and Testing (BAM). This kind of exception is possible, if the radioactive source used in the device fulfils at least the requirements of the ISO classification according to DIN EN ISO 2919 Table 3 and tightness of the radioactive source is ensured with respect to material, design and operating conditions of the device.

No, type approvals will not be granted for devices with contained radioactive substances with an activity below the exemption limit acc. to Annex 4, Table 1, Column 2 StrlSchV. Acc. to § 5 (1) StrlSchV a practice for commercial purposes (no private use) involving a radioactive substance with an activity below the exemption limit is free from licensing or notification anyway.

On the other hand, you might apply for a license of the production of a device as a consumer good containing radioactive substances pursuant to § 40 StrlSchG, in particular as a “consumer good which is used mainly in a professional and not in a domestic context” (§ 41 (2) StrlSchG). An application for a license of the production of a consumer good containing radioactive substances pursuant to § 40 StrlSchG has to be submitted to the competent authority of the Federal State.

Yes, a femtosecond laser (ultra short pulse laser - USP laser) is a laser machine, that may come within the scope of the radiation protection regulations StrlSchG and StrlSchV, because the plasma resulting from the laser beam hitting the target material can cause ionizing radiation. In this case USP lasers are considered being an “accelerator” acc. to § 5 (2) StrlSchG. The origin of ionizing radiation from USP lasers is quite complex and depends on the operational mode of the laser, the target material and the geometry of the beam.

Not every USP laser is subject to radiation protection regulations. In particular, USP lasers, where the beam intensity is less than 1013 W/cm² and the ambient equivalent dose rate at a distance of 10 cm from the surface of the laser does not exceed 1 µSv/h, are free from licensing or notification acc. to Annex 3 part C no. 2 StrlSchV. According to Annex 3 part C no. 1 StrlSchV USP lasers, which are type approved, are free from from licensing or notification too. Every other USP laser, which does not fulfill the above mentioned requirements, is subject to licensing.

An USP laser might get a type approval, if it is ensured, that the ambient equivalent dose rate at a distance of 10 cm from the surface of the laser does not exceed 1 µSv/h at standard operating conditions acc. to § 17 StrlSchV. An application for a type approval acc. to § 45 (1) no. 1 StrlSchG of an USP laser can be submitted to the BfS and will be granted in case all the legal requirements are fulfilled.

Yes. In case the radiation protection relevant features (design and activity of the radioactive source, device shielding etc.) of a type approved device are modified, an amendment to the approval certificate must be applied for at the BfS.

The type approval holder shall submit relevant technical documents to BfS, which contain a complete and explicit description of the intended modifications, together with a free form application for a type approval modification. BfS decides – optionally consulting the Federal Institute for Materials Research and Testing (BAM) – if another type test of the modified device is necessary. If all the requirements are fulfilled, the type approval certificate will be amended and the amendment will be published in the Federal Gazette.

A type approved device, which has been taken into operation (means: it is currently used), must not be changed concerning its radiation protection relevant features. Otherwise, the corresponding type approval is not valid anymore and the device might not be operated free from licensing and notification.

The BfS must be informed immediately in case the type approval holders trade name, the manufacturers name or the persons in charge etc. do change. All changes require an amendment to the approval certificate to be applied for at BfS. Such application shall be accompanied by official or notarized documents - for example an excerpt from the commercial register, a partnership agreement, a Certificate of good conduct to be presented to public authorities pursuant to § 30 (5) of the Federal Central Register Act and/or qualification certificates.

The operator of a type approved device can sell or transfer the device to third parties. A copy of the type approval certificate and its amendments has to be handed over to the new owner ("acquirer") together with all technical documents. The acquirer can continue the use of the device provided that the requirements of the granted type approval are fulfilled.

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

A free form application in order to extent the expiry of the type approval shall be submitted to BfS at least three months before the type approval expires. Such application shall be accompanied by the administrative and technical form sheets filled out completely. Type drawings of the device in its current version shall also be submitted.

In case of an application for extending the type approval it will be proved that the device conforms to the state-of-the-art according to the legal and technical requirements valid at the time of the application. Another type testing performed by the BfS - and possibly the BAM - may be required. If all requirements are fulfilled, BfS will extend the type approval.

An extension of the type approval period is not possible when the type approval is already expired. In this case the type approval holder has to apply for a new type approval, if desired.

Once the approval period has expired, the device must not be put into circulation as "type approved device".

Every type approved device, that has been put into circulation (is in use) when the approval period expires, can be operated further on – provided that the requirements of the corresponding type approval are still fulfilled. This remains valid since the device complies with the essential radiation protection relevant features and is not damaged and the BfS has not announced, that the device must no longer be operated.

According to § 25 (5) StrlSchV the user of a type approved device must return the device to the holder of the type approval immediately after the end of use. If this is not possible, the device and/or the radioactive source shall be delivered to a collecting depot of the Federal State ("Landessammelstelle") or to a facility as determined by the competent Federal State Authority.