+39 0444 233711
info@soiort.com

HISTORY

A company founded at
the state of the art

SIT SpA was formed by the merger of Sordina, founded in 1878, with New Radiant Technology, a specialist in radiation emitter devices. Drawing on the experience of an organisation that produced the first operating table, the first steriliser and the first mobile linear accelerator in history, SIT is now world leader in the manufacture of LINACs for IORT (Intra Operative Radiation Therapy) and operates on every continent, with installations, business units, distributors and engineers.
It is the only Italian company, and one of the few worldwide, capable of designing, building and distributing linear electron accelerators (LINACs) for IORT. Its creation sprang from the desire to provide an industrial form to a wealth of knowledge in the field of particle physics, microwaves, electronics and vacuum brazing.

The construction of electronic accelerators requires a combination of high-level expertise in widely varying sectors, ranging from ultra high vacuum technology to microwaves, radio-frequency emissions and high voltages. These skills are made available, even individually, to industry and national and international research.

The device manufacturing and service provision cycles are carefully designed and developed to optimise both production times and the costs of the materials used. The company has designed and built various types of particle accelerators to order for both private customers and the public sector.

Technology for quality of life

SIT stands for ceaseless research and innovation, with unique technological solutions intended to increase the efficacy of therapy for patients, who demand instruments capable of improving both their life expectancy and their quality of life.

Our daily task: improvement

SIT has adopted a quality policy that has led to today’s UNI EN ISO 9001:2008 and UNI EN ISO 13485:2004 certification. We view quality as the best way of planning, implementing and improving our management of the production, sales and managerial process. The aim is always to assure the customer complete, prompt, professional service.

The quality management system enables SIT to increase its efficiency by optimising processes and cutting waste. In our opinion, total quality is an essential tool for every aspect of the corporate organisation, and includes a common system of values, know-how and procedures. Constant striving for the best performance in the shortest possible time and smallest possible space requires us to use the best components on the market to create miniaturised, mobile, effective linear accelerators.

Training for continual growth

SIT sets initial minimal requirements in terms of educational qualifications, training and experience and then aims to constantly improve its staff’s skill levels. Training and educational activities play the important role of ensuring that all staff are aware of their tasks’ importance for the achievement of the company’s quality targets. Staff are highly qualified, with 60% graduates.

All the safety that
comes from compliance

All our products are fully compliant with the relevant quality and safety standards. The following is a list of the numbers and brief contents of the relevant Sections of the IEC 60601-2-1 Standard:

Second Edition (1998) + Am. 1 (2002), relevant sections:

6.1 External marking of the device or its parts (collimators)
6.7 Indicator lights and push-buttons
10.2.2 Electricity supply
22 Movable parts
28.101 Fixing of accessories (collimators)
29.1.1 Monitoring and control of the dose absorbed (two independent monitoring cameras)
29.1.2 Control timer
29.1.3 Absorbed dose rate (dose rate monitoring system, display)
29.1.4 Energy Setting and Display
29.1.9 Electron beam applicators and radiation beam modifier device supports
29.1.10 Control of use of the device (normal/service)
29.1.11 Start-up conditions
29.1.12 Radiation emission cut-off (mechanical, by software, safety devices)
29.1.13 End of emission
29.1.14 Anomalous end of emission
29.2.1 Protection against leakage radiation within the radiation field (definition of “Residual dose due to electron Bremsstrahlung” and its limit values)
29.2.3 Neutron Leakage Radiation (only applies for model with EMAX 12 MeV)
29.4.1 Protection against leakage radiation outside the radiation field (definition of “Leakage dose due to electron Bremsstrahlung” and its limit values) see page
29.4.2 Neutron leakage radiation outside the patient plane (only applies for model with EMAX 12 MeV)
29.4.3 Emission of ionizing radiation after the end of emission due to induced radioactivity (only applies for model with EMA 12 MeV)

MEDICAL DEVICE CERTIFICATION

IEC 60601 1:1988 + A1:1991 +A2:1995 Medical electrical equipment Part 1: General requirements for safety 9
IEC 60601-1-2: Second Edition (2002) + Am. 1 (2006) Medical electrical equipment Part 1: Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-2-1: Second Edition (1998) + Am. 1 (2002) Medical electrical equipment Part 2: Particular requirements for electron accelerators in the range 1 MeV to 50 MeV