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IEC 60601-1-2 EMC Testing Services for Medical Devices

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Test Labs Ltd offers advanced EMC testing programs specifically tailored for active medical devices and systems, adhering to IEC 60601-1-2 standards. These standards focus on defining emission and immunity criteria crucial for medical equipment safety and performance. The company evaluates 'combined equipment' that incorporates radio technologies for data transmission, ensuring that they operate within safe electromagnetic disturbance levels. Additionally, Test Labs develops test programs for medical devices used in both domestic and emergency environments, addressing potential electromagnetic interference from RFID/EAS systems. By offering pre-compliance evaluations, Test Labs enables manufacturers to identify and mitigate potential compliance failures early in the product development cycle, thus reducing costs associated with repeated testing. With accreditations like UKAS and GLP, Test Labs' facilities are equipped with cutting-edge technologies, enabling detailed analysis and major performance testing of medical devices.

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IEC 60601-1-2:2020 (ed. 4.1) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

  • Evaluation of ``combined equipment`` – medical devices and systems that use radio technologies to send or receive data
  • Test program ``out of hospital`` for equipment and systems that can be used in a domestic environment and in an emergency
  • Testing of interference from RFID/EAS systems
  • Review and verification of EMC test plans, risk analysis, and user manuals