Testing of medical equipment
Nemko has extensive experience testing many kinds of medical equipment.
Our testing forms the basis for your CB certificate and your technical files for national approvals world wide.
To ensure that your product is safe for both patient and operator, we can help you with product requirements and safety testing.
Our testing laboratories features advanced test equipment that can measure and stress your product to make sure it fulfils all compliance requirements for your planned markets.
Applicable standards for medical equipment:
- EN/IEC 60601-1 (General requirements for basic safety and essential performance)
- EN/IEC 60601-1-xx (Collateral standards)
- EN/IEC 60601-2-xx (Particular standards)
- ISO/IEC 80601-2-xx (Particular standards)
Nemko assist you to ensure product compliance with more than fifty particular standards, including safety, risk management, usability, software, EMC and environmental (impact on both product and environment)