EMC testing is essential for medical electrical equipment intended for hospital, outpatient and healthcare settings, where electromagnetic interference can compromise safety and clinical effectiveness.
Testing and Measurements for the Medical Device Sector
Our testing capabilities are supported by our laboratory facilities, the continuous development of our technical expertise and, above all, the multidisciplinary approach that characterizes Tecnolab across its areas of expertise.
Standards and Regulations: The Foundation for Reliable Testing and Certification
The standards and regulations that ensure safety, quality, and compliance in our laboratory testing.
Standards for the Medical Device Sector
- EN / IEC 60601-1-2
- EN / IEC 55011
- EN / IEC 62333
- EN / IEC 62311
- EN / IEC 60601-1
- EN / IEC 60601-x Particolar requirements
- EN / IEC 60601-1-11
- EN / IEC 60601-1-6
- EN / IEC 60529
- EN / IEC 62262 and EN / IEC 60068-2-75 using the “vertical hammer” method
- EN / IEC 60068-2-6 (Sinusoidal vibration)
- EN / IEC 60068-2-27 (Mechanical shock)
- EN / IEC 60068-2-64 (Random vibration)
- EN / IEC 60068-2-1 (Cold)
- EN / IEC 60068-2-2 (Dry heat)
- EN / IEC 60068-2-14 (Temperature change)
- EN / IEC 60068-2-30 (Cyclic damp heat)
- EN / IEC 60068-2-38 (Combined temperature and humidity cyclic test)
- EN / IEC 60068-2-78 (Damp heat, steady state)
- EN / IEC 60068-2-11 (Salt mist)
Follow-up Actions
Tecnolab performs testing in accordance with the applicable medical device standards. In the event of non-compliance, we support Customers in identifying the causes of the issues and implementing the necessary technical solutions to achieve compliance and support the CE marking process, including the manufacturer’s MDR conformity assessment.
Test your products with Tecnolab!
Rely on our experience to ensure your products are compliant.
Contact us today for a personalized consultation!
