Electromagnetic Compatibility (EMC)
Medical devices are expected to perform at a certain level in any electromagnetic environment without causing interference to other equipment.
LNE can test your devices to ensure conformity to harmonized European or other EMC standards and for voluntary certification.
Our technical team provides assessment of finished products, components and prototypes of medical devices. We also analyze technical files to define tests programs and performance of tests.
Core Capabilities
With its EMC chamber immunity and benches, LNE performs EMC tests according to EN 61000-4-3, with a capability to generate electromagnetic fields from 26 MHz to 3 GHz. Its test cage allows performing tests from 3 to 5 meters away from antenna.
LNE tests all electrical and electronic equipment (plug-in or battery operated), which is liable to generate or be affected by electromagnetic interference, such as:
- Information technology equipment
- Laboratory equipment
- Industrial machinery
- Electro medical equipment (in the context of Directive 93/42/EEC on medical devices)
LNE is an active member of several EMC standardization committees and Eurolab committees. French accreditation committee COFRAC approved LNE as a Notified Body for the EMC Directive and carries out EMC tests according to EN 60601-1-2
Advantages
LNE has experience working with manufacturers to test a wide range of devices, providing an economical and reliable solution.
In addition, we offer:
With highly advanced testing equipment and over 60,000 square yards of laboratory space, LNE can address a wide range of standardized tests or customize a test to characterize your product.
Our multidisciplinary teams possess deep knowledge on various European, international and other regulatory standards. Throughout the entire testing process, our team is available for technical meetings to provide insight into any discovered non-conformities.
Such as for ISO 13485, CE Marking, and other certificates.
With offices worldwide, you get the conveniency of a local based team, who will work with you closely to define program details and ensure your timeframe is met.
Combine your certifications to reduce time and cost
Request a Medical Device Certification
We serve the medical device industry worldwide with offices in Europe and the United States.