EMC and safety tests of medical devices are more than a procedure. We guarantee patient and operator safety, accelerating your MDR (Medical Device Regulation) processes.
Medical devices must perform the most precise measurements in noisy (high magnetic field) environments such as hospitals. A patient monitor next to an electrocautery device operating must not malfunction.
Consept specializes in **EN 60601-1-2 (EMC)** and **EN 60601-1 (Safety)** standard series. We ensure that your device not only complies with standards but also creates technical evidence compatible with the Risk Management File (ISO 14971).
Verification of MOPP (Means of Patient Protection) isolation barriers.
MOOP (Means of Operator Protection) and touch currents.
Development process of a portable Ventilator (Respiratory Device).
The device was momentarily turning off and on when exposed to electrostatic discharge (ESD) in a home environment (especially when a person walking on a carpet in winter touches it). For a life support unit, this situation was in the "Unacceptable Risk" class.
Result: The device continued to operate uninterruptedly (Criterion A) despite ±15kV air discharge.
RF immunity and ESD tests in accordance with 4th Edition requirements. Test plans for home care and professional healthcare facility environments.
General safety rules. Leakage currents, dielectric strength, mechanical robustness and overheating tests.
Verification of auditory and visual alarms according to EN 60601-1-8 standard. Sound level and frequency analyses.
EN 60601-1-11 standard. Robustness and usage error tests of devices operated by untrained users.
EN 62366 Usability Engineering. Analysis of risks that may arise from user interface errors.
ISO 11607 and ISTA series. Protection of sterile barrier systems under transport and storage conditions.
