Erstellt am 15.12.2019 06:51

Ausgedruckt von null null

Type-approvals
Business management → Radiation protection

Requirement

Name

Type-approvals (B)

General information

Everyone who wants to launch greater quantities of equipment emitting ionising radiation on the market in Austria can apply for type-approval. Typical appliances which are approved within the framework of type-approval are ionisation smoke detectors, density meters, coating thickness gauges and level meters, baggage scanners, food control probes or gammagraphy devices. In this context a distinction is made between tools with lower and with higher potential hazard (application according to section 19 Radiation Protection ActGerman text, e.g. electron capture detectors and/or application according to section 20 Radiation Protection ActGerman text, e.g. gammagraphy devices or baggage scanners).

Maximum activity and dose rate values for the delimitation between approvals according to section 19 and section 20 Radiation Protection ActGerman text are laid down in section 8 of the Allgemeine Strahlenschutzverordnung.

The official type-approval procedure is very similar to the approval procedure for the handling of radiation sources.
Important obligations of the holder of an approval are:

  • Passing on of a type certificate for every appliance to the user (section 22 Radiation Protection ActGerman text): The certificate contains information about the approved type of use, the conditions and requirements for the use as well as information about the required controls.
  • Notification requirement to the Central Register of Radiation SourcesGerman text: For every appliance containing radioactive substances delivered preferably currently, but at least for each calendar year, name and address of the recipient, type and series number, number of the type certificate as well as radionuclide and activity are to be forwarded.
  • In the case of highly radioactive radiation sources (e.g. gammagraphy devices): Conclusion of a take-back agreement with the supplier.

Appliances approved according to section 19 Radiation Protection ActGerman text can be operated without handling authorisation. Also a notification of the competent radiation protection authority is only necessary if this is explicitly required in the type certificate. For appliances containing radioactive substances there is, however, a notification obligation to the Central Register of Radiation SourcesGerman text.
Type approvals according to section 20 Radiation Protection ActGerman text replace only in exceptional cases a handling authorisationGerman text of the holders, in any case there is a notification requirement to the competent radiation protection authority and for appliances with radioactive substances also to the Central Register of Radiation SourcesGerman text.

By means of the type certificate the user will be put in the position to be able operate the machine according to radiation protection requirements, however, there is also an obligation to comply also with all other radiation protection provisions not explicitly mentioned in the type certificate. In the case of appliances with radioactive substances this could be for example the conclusion of liability management provisions according to the Austrian Nuclear Liability ActGerman textor also the notification to the authority how the radioactive substances are disposed of after the end of use of the appliance.

Prerequisites

In the case of a domestic producer the domestic producer is entitled to file an application for a type-approval, whereas in the case of foreign producers, their assignees in Austria are entitled to file the application. In exceptional cases an application by the user is possible. As far as the reliability of the applicant is concerned there must not be any doubts.

The appliance must comply with the recognized state of technology.

In the case of type-approvals of appliances which are equipped with a CE label for the purposes of the Medical Devices Act it can be proceeded on the assumption that such appliances comply with the radiation protection requirements.

Deadlines

The authority shall issue a decree within a period of six months from filing an application.

Costs

Forms


Responsible department

Competent authority


Detail information

Procedure

The type-approval procedure takes place upon written application. The application must contain all documents allowing the authority to check whether the requirements for safe handling are met. This includes in particular:

  • Exact description of the appliance including plans
  • Indication of the purpose of use
  • Expert opinion by a qualified expert on the compliance with the technical requirements for type-approval
  • Safety assessment, accident analysis and, where appropriate, emergency plan
  • If necessary, a concept for the disposal of radioactive waste
  • Extract from the judicial record and from the register of companies
  • In case of highly radioactive sourcesGerman text: Proof of a take-back agreement with the supplier

After positive conclusion of the Audit, the authority shall issue a type approval decree containing conditions and requirements on the one hand for the placing on the market and on the other hand for the use. On the basis of the decree the holder of the approval shall issue the type certificate.

Legal basis

Sections 19 to 22 Radiation Protection ActGerman text