Testing of electromedical devices

The development and manufacture of electromedical equipment requires the management of complex bills of materials and the integration of electronic, plastic and mechanical components. To ensure operational safety and continuity of operation in the clinical or home environment, machines must undergo rigorous validation cycles.

Testing plans allow hardware resistance to environmental and mechanical stresses to be verified, while ensuring that the entire component complies with European and international directives on hazardous substances.

Testing and validation of electromedical devices with TEC Eurolab

For the world of electromedical devices, TEC Eurolab performs various types of functional and environmental testing. We support companies in quality control of the supplier chain, as well as Rohs analysis and certification.

Regulatory Compliance and Supply Chain Control

RoHS analysis and certification: analytical investigations to quantify the presence of restricted substances (such as lead, cadmium, mercury and phthalates) on electronic boards, cables, solder and plastics, a mandatory requirement for CE marking of medical electrical and electronic equipment.

Inspections and audits: inspection activities at suppliers (second party audits) to ascertain the soundness of production processes and the proper implementation of quality management systems, ensuring the traceability and performance consistency of supply lots.

Hardware Reliability: Dynamic and Climatic Tests

Environmental and functional tests: exposure of the equipment to accelerated aging cycles, extreme changes in temperature and controlled humidity inside climatic chambers in order to verify the tightness of the displays, the absence of drifts in the sensors, and the proper startup and operation of the integrated software (stress on/off).

Dynamic tests: simulation of mechanical stresses (random or sinusoidal vibrations, mechanical shocks, and drop tests) to reproduce logistics transportation conditions or use on emergency vehicles. These tests ascertain the structural integrity of chassis and the strength of internal electronic connections against fatigue failure or accidental disconnection.

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