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Medical Electrical Equipment

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Worldwide medical devices are controlled by strictly adjusted regional approval procedures, which also typically require testing by approved laboratories. In the field of active medical devices, these requirements are documented and internationally harmonized under the standard family IEC 60601. Currently, the IEC 60601-1 3rd edition is the base for the approval procedure of medical electrical equipment in most regulatory frameworks all over the world. Due to identical requirements of EN 60601, the IEC defines the assumption of conformity to MDD 93/42/EEC.

Eurofins Medical Device Testing performs testing according to IEC/EN 60601 standards for medical electrical equipment and documents the results in test reports and test certificates. We are supervised by regular inspections of the IEC Assessors and documented within the listing on the IECEE Website with the following scope of accreditation:

  • IEC 60601-1 (2nd and 3rd Edition) Basic standard
  • IEC 60601-1-2 EMC
  • IEC 60601-1-4 and IEC 62304 PEMS
  • IEC 60601-1-6 and IEC 62366 Usability
  • IEC 60601-1-8 Alarms
  • IEC 60601-1-11 Home Health Care 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

Choose Eurofins Medical Device Testing to help you:

✔ Check basic safety and essential performances

✔  Ensure conformity to IEC/EN 60601 standards

✔  Document test results in test reports and certificates

✔  Get CB test reports and certificates

 

Testing Services for Medical Electrical Equipment
Electrical Safety tests Electromagnetic Compatibility tests Performance tests