Medical Device EMC Testing
We perform all the EMC and electrical tests for US FDA 510 (k) pre-market notification process and for the Medical Device Directive 93/42/EEC and CE Testing. Elite services also include a full environmental stress test laboratory meaning we can provide one-stop for both EMC/ electrical testing and environmental stress testing. Our environmental stress testing covers temperature chambers and vibration equipment to stress parts and identify latent defects. We also provide mechanical testing to evaluate life cycle stresses for push buttons, pumping action, and other motions and forces.
In the recently released IEC 60601-1-2 Edition 4, the radiated immunity requirements are increasing in amplitude and frequency range from 80MHz-2.7GHz at 30V/m at 3 meters distance. The new test requirements also extend at 10V/m from 2.7GHz to 6GHz. This much higher requirement can only be met using the type of large high power amplifiers which Elite uses extensively today for its current clientele.