Medical X-ray systems

The installation and operation of a medical X-ray system is subject to authorization. In the medical sector, the Office of Public Health is the licensing and supervisory authority.

Requirements for medical facilities

The requirements for obtaining a license are defined in radiation protection legislation, in particular

• The existence of medical expertise (medical responsibility; medical expertise)
• Appointment of at least one trained radiation protection expert (technical expertise)
• sufficient liability insurance in the company
• Equipment, aids, facilities and premises must correspond to the state of the art in science and technology
• Implementation of a quality assurance program (acceptance test, constancy tests, maintenance with status check of the entire imaging chain)
• Compliance with radiation protection regulations(dosimetry, protective equipment, education and training, etc.)

The website of the Swiss Federal Office of Public Health (FOPH) publishes guidelines for X-ray systems on various topics such as technical quality assurance, diagnostic reference values and personal protection. These guidelines specify the legal requirements and reflect the current state of science and technology.

Authorization procedure

Prior to installation, the operator must submit a license application with radiation protection construction plans of the X-ray room and corresponding calculations of the structural radiation protection in accordance with the X-ray Ordinance(chRöV). The responsible persons must be designated by name and trained in accordance with their functions.

The completed application form "Operation of a medical X-ray system" can be submitted to the Office of Public Health electronically and without a signature by e-mail(martin.stricker@llv.li).

Examination and granting of authorization

If all the necessary requirements are met on the basis of the documents submitted, the permit for installation and operation will be issued by the Office of Public Health. Without this permit, the X-ray system may not be installed and handed over for operation by the supplier.
The permit is valid for a limited period of 10 years. It always refers to the medical operation with the responsible persons as well as to the area of application, type and location of the X-ray system.
The licensing procedure is subject to a fee, the fees are regulated in the Fees Ordinance .

Tasks and changes during the period of validity

In the event of a change of license holder (e.g. transfer of practice) or relocation of the facility, both within the practice and in the event of relocation of the practice, the previous license expires and a new license application must be submitted with the new conditions. Under certain conditions, a permit can only be amended during its term. The Office of Public Health must be notified immediately of any changes that make it necessary to amend the license.

The license holder must ensure the functioning of the entire X-ray system by means of a quality assurance program for radiation protection (Art. 26 chRöV). In addition, all persons who handle ionizing radiation must be trained and educated in radiation protection in accordance with their responsibilities and activities.

During the period of validity of a license, the Office of Public Health carries out random inspections and audits in the medical facilities to check whether the radiation protection regulations are being implemented and, in particular, whether the quality checks, especially the maintenance/condition checks by the X-ray companies, have been carried out correctly.

Tasks and duties of the radiation protection expert (technical expertise)

The license holder or the person in charge of an establishment is responsible for ensuring that the radiation protection regulations are complied with. To this end, they must appoint an appropriate number of radiation protection experts and provide them with the necessary skills and resources (Art. 16 Radiation Protection Act).

The duties and tasks of the radiation protection expert(s) are divided into the following areas in particular:

• Administrative and organizational tasks
• Education and training in radiation protection
• Technical tasks
• Waste treatment
• Reporting duties
• Incident management

The duties and tasks of the radiation protection expert are clearly summarized in the FOPH guidelines "Duties and tasks of the radiation protection expert in the area of the use of ionizing radiation".