Medical Devices

Medical devices are subject to highly regulated approval procedures worldwide, which also require testing by recognized testing laboratories. In the field of active medical devices, the specifications for these tests are described in the IEC 60601 family of standards and coordinated internationally. For example, the IEC 60601-1 (Edition 3.1) and the 60601-1-2 (Edition 4) are currently the basis for the approval of medical devices in most regulatory codes. In Europe, the EN 60601 family of standards, which is usually identical on the requirements side, has a presumption of conformance with the MDD 93/42/EEC.

In our testing laboratory, we can carry out the tests required for active medical devices market access worldwide. After successful completion of the compliance process, we issue you with test reports and test certificates in accordance with the CB Scheme. The competence of the laboratory is monitored by regular inspections by the IEC and documented on the website of the IECEE.

Our accredited capabilities include the following standards, which are also listed on the website of the IECEE:

• IEC 60601-1 (Basic Standard)
• IEC 60601-1-2 (EMC)
• IEC 60601-1-4, IEC 62304 (PEMS)
• IEC 60601-1-6, IEC 62366 (Serviceability)
• IEC 60601-1-8 (Alarms)
• IEC 60601-1-11 (Use in a domestic environment)
• IEC 60601-2-10 (Stimulation)
• IEC 60601-2-27 (ECG)
• IEC 60601-2-31 (External pacemaker)
• IEC 60601-2-40 (EMG)
• IEC 60601-2-49 (Patient monitoring)
• IEC 60601-2-66 (Hearing aids)

Even if your standard of interest is not listed above, please contact us as it is often possible to add an additional standard to the scope of the testing laboratory and the Certification Body at short notice.

Contact Us:
+49 33631 888 801
EEinfoDE@eurofins.com