Medical Electrical Equipment
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.
For more information contact Eurofins Medical Device Testing
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