The Cofrac-accredited Emitech laboratory at Chassieu, along with the Montpellier laboratory, forms the Group's medical center. The center is equipped with EMC, radio and electrical safety testing capabilities. This threefold expertise enables us to support our customers in the procedures involved in bringing equipment to market in Europe, with CE marking, and worldwide, with our role as CBTL within the framework of the OC scheme. These procedures now include on-site incorporation tests, both in France and abroad. Among the various sectors concerned by these regulations, the medical sector is subject to particular requirements in terms of both testing and approval procedures, and the Chassieu site has developed specific skills in this field, including being CBTL for the OC-MED and OC-CEM/MED schemes.
Henri-Louis Richard, head of Emitech's Chassieu laboratory, has been carrying out medical equipment incorporation tests in several countries around the world for the past four years, on behalf of his customer IBA. The latter has developed a proton therapy equipment called Proteus 235, a custom-designed intensity-modulated proton beam technology whose protocols provide a solution for patients suffering from a wide variety of complex cancer diseases. Proteus is more than a medical solution, it's a complete installation within a hospital building, with several treatment rooms and a particle gas pedal whose protection against radiation induced during gas pedal operation is provided by thick concrete walls (as radiological protection).
An unprecedented, long-term test campaign
"A single test campaign like this lasts about a year. The Proteus 235 system comprises over thirty electrical cabinets, a water cooling room and numerous Human Machine Interfaces (HMI), in addition to the platform equipment itself. This is where the various pieces of equipment for tumor localization, visualization and treatment are interconnected (X-rays, scanner, robot, radio equipment), all of which we test individually," explains Henri-Louis Richard. In the initial phase, Emitech carried out the first tests directly on IBA's site in Belgium (modules in the development phase), then in its laboratories (down to the smallest electrical component in the cabinets)."
Subsequently, the complete installation is inspected and tested in-situ (for final system incorporation), to take account of full hardware integration and hardware installation (e.g. network connection). Emitech's services integrate national deviations from international standards (a kind of local upgrading). Finally, Emitech's teams draw up the normative documents corresponding to each country with the various deviations. Tests are generally the same as in the laboratory, but at different levels.
For two years now, IBA has been calling on Emitech for similar test campaigns concerning sterilization equipment based on a similar process using electron acceleration at several MeV, known as Rhodotron, Dynamitron and Cyclotron. Henri-Louis Richard adds: "These campaigns proceed in the same way. We carried out incorporation tests, but with the difference that this type of equipment is assimilated to a machine. We therefore had to add to our tests the protocols relating to the Machine Directive in addition to those relating to the Low Voltage Directive (safety requirements for electrical equipment). Sterilization equipment needs to be tested in situ because each configuration is unique to meet the end customer's specifications. These incorporation tests have been successfully carried out in a dozen countries, including China, South Korea, the USA, the Dominican Republic, Vietnam and Italy.
To ensure that the technical file, essential to any homologation process, is properly prepared, Emitech systematically offers a pre-analysis of the product from the design phase onwards, in relation to the requirements set by the applicable regulations (European directives, harmonized standards, national deviations, etc.), and carries out pre-qualification tests to validate the solutions and technologies used, before moving on to the final tests.
"These international incorporation test campaigns carried out for our customer IBA were a real catalyst for structuring our teams and processes," adds Henri-Louis Richard.
The laboratory now conducts incorporation test campaigns for other customers, with the same particularity of having to accompany them around the world.
In doing so, it is true to its motto, "we turn your tests into successes", since the success of these measurement campaigns determines the market launch of products and the commissioning of installations.
Visit the site:
www.emitech.fr