Type-approvals

• Companies wishing to place equipment on the market in Austria that may emit ionising radiation or contain radioactive substances, and
• users of such equipment.

• List of type approvals in Austria in the non-medical field (→ BMK)^{German text}
• Data Protection and Privacy Statement pursuant Art. 13 DSGVO (Application for Type Approval) (→ BMK)^{German text}

There are no specific deadlines to be observed.

In Austria, an application for type approval can be made if the device contains radiation sources, if certain conditions are fulfilled and if the device is to be placed on the market in larger quantities (section 33 of the Strahlenschutzgesetz 2020). The advantage for the user of the respective device is a lower administrative effort compared to individual licensing in accordance with sections 15 and 17 of the Strahlenschutzgesetz 2020. By receiving the type certificate, the user is enabled to operate the device in accordance with the specifications (conditions and requirements) of the approval authority. In addition to the conditions and requirements explicitly stated in the typecertificate, the user is obliged to comply with all applicable radiation protection regulations from the Strahlenschutzgesetz 2020 and the associated ordinances.

Devices with a lower hazard potential may be approved as a type approval according to section 33 of the Strahlenschutzgesetz 2020. All other devices must be subject to individual licensing (sections 15 and 17 of the Strahlenschutzgesetz 2020 – practices subject to authorisation). Examples of equipment that have already been approved as a type approval are electron capture detectors for gas chromatography, X-ray spectrometers, baggage scanners or food control equipment.

For the classification of the hazard potential, the activity of the radioactive substance contained therein and the local dose rate in the environment are decisive. Low hazard potential means that

• the local dose rate of the device used at 10 cm from the surface shall not exceed 3 µSv/h, and
• where a radionuclide is used for the activity, ten times the exemption limit must be observed.

The exemption limit for the total activity has remained unchanged compared to that in the radiation protection law applicable thus far.

The company placing the device on the market will report every transfer of a type-approved device to a user via the Central Source Register. This also applies if no radioactive substances are contained, as in the case of pure X-ray equipment, for example. Any transfer of the equipment by the user to another company must also be administered in the Central Source Register. Until 1 August 2020, this obligation to notify applied only to equipment containing radioactive sources. Reporting in the Central Source Register automatically results in a notification to the competent authority for the user.

Essential obligations of the holder of a type approval are:

• The enclosure of a type certificate for each device to the user as well as operating instructions in the German language for each device (section 35 paragraph 1 of the Strahlenschutzgesetz 2020). The type certificate is an official document and contains information on the approved use as well as the conditions and requirements for use. A detailed list of the contents of the design certificate is contained in section 23 paragraph 1 of the Allgemeine Strahlenschutzverordnung 2020.
• Before placing the product on the market for the first time, a sample of the type certificate must be submitted to the Federal Ministry for Climate Protection, Environment, Energy, Mobility, Innovation and Technologies (BMK) for examination. If no objections are raised within 14 days, the device may be placed on the market with the type certificate (section 35 paragraph 2 Strahlenschutzgesetz 2020).
• Obligation to report to the Central Source Register: For each device placed on the market, the name and address of the user, if applicable company register number, type and serial number, number of the type certificate and, if applicable, the radionuclide used with the associated activity must be entered without delay.

Essential obligations of the user of a type-approved device are:

• The device may only be used for the application approved in accordance with the type certificate. The conditions and requirements specified in the type approval certificate must be fulfilled and adhered to.
• The competent authority must be informed in writing without delay of the commencement of the activity and a copy of the type certificate must be sent to it. This notification must be made in addition to the notification of transfer in the Central Source Register.
• The device must be passed on together with the type certificate, the operating instructions and all other documents relevant to radiation protection enclosed with the device. It must be reported via the Central Source Register.
• The termination of the activity shall be notified to the competent authority without delay. If equipment containing radioactive substances is disposed of, then the user must prove that it has been disposed of in accordance with radiation protection regulations.

Innovations with the entry into force of the new radiation protection law on 1 August 2020

Only devices with a lower hazard potential may be approved as type approval. This means not more than a 3 µSv/h local dose rate at a distance of 10 cm from the surface and not more than ten times the exemption limit as the activity. For devices that have been approved in the past as a type approval, transitional provisions can be found in the Strahlenschutzgesetz 2020 (section 157 paragraph 2 to 5).

The notification obligations of the person placing the product on the market and the user have been clearly defined.

For all type-approved devices, the transfer must be reported to the Central Source Register. This also applies to equipment that does not contain radioactive substances. The obligation to report applies both to the transfer from the person placing the equipment on the market to the user and from the user to another user.

The person placing a type-approved device on the market must provide evidence that the characteristics of the type approval are fulfilled for each device to be placed on the market.

The costs are based on Appendix 1 – Section VII of the Bundesverwaltungsabgabenverordnung 1983 (Federal Administrative Fee Ordinance 1983) and section 14 tariff (5) and (6) of the Gebührengesetzes 1957 (Fees Act 1957)

• Sections 33 to 36 of the Strahlenschutzgesetz 2020 (Radiation Protection Act 2020)
• Sections 21 to 25 of the Allgemeine Strahlenschutzverordnung 2020 (General Radiation Protection Ordinance 2020)

The procedure for approval of a design type shall be carried out on written application. This can be submitted electronically. According to section 22 of the Allgemeine Strahlenschutzverordnung 2020, the application must contain all the documents that will enable the authority to verify whether the conditions for safe use of the device are met. This includes in particular:

• Indication of the intended use of the device
• The exact description of the device including plans (such as technical drawings, lead shielding) and description of the safety devices relevant for radiation protection
• Functionality
• Technical and other radiation protection relevant information on the source
• Proof of compliance with the requirements for type approval in accordance with section 21 of the Allgemeine Strahlenschutzverordnung 2020
• Demonstration that the equipment is designed in such a way that under normal operating conditions the release of radioactive substances into the environment is prevented with certainty
• Criminal records and extract from the commercial register
• Presentation of the precautions and measures taken to ensure that each device corresponds to the characteristics of the type (for example, through proof of an internal company QM system, ISO certification)

After positive completion of the test, the authority will issue a type approval certificate within six months. The period does not begin to run until the application has been submitted in full.

The type approval certificate contains the conditions and requirements for placement on the market on the one hand and use on the other. The conditions and requirements for use must be included in the type approval certificate by the holder of the type approval. The user is legally obliged to comply with these conditions and requirements.

The approval of a type may be applied for by a domestic manufacturer. In the case of foreign manufacturers, their authorised representative(s) in Austria is/are entitled to submit an application. There must not be any doubts regarding the reliability of the applicant.

The device must correspond to the recognised current level of technology (state-of-the-art).

• Approval as design type: Federal Ministry for Climate Protection, Environment, Energy, Mobility, Innovation and Technology (→ BMK)
• Use of type-approved devices: the respective office of the state government.