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Basic Safety and Essential Performance Test

Manufacturers of electrical medical devices must carefully manage every stage of product development, from initial design input to final product launch, to ensure compliance with strict regulatory standards. A thorough understanding of the requirements for basic safety and essential performance is essential. These requirements must be fully integrated into the design process and verified through comprehensive testing to minimize risks to patients and users. In addition to technical compliance, manufacturers are also responsible for preparing clear and detailed documentation that demonstrates their products meet the applicable Recognized Consensus Standards or Harmonized Standards. These standards are established by national medical device regulatory authorities to ensure the safety, reliability, and effectiveness of medical devices on the market. Proper documentation not only supports regulatory submissions and approvals but also builds trust with stakeholders and facilitates global market access. Failing to meet these expectations can lead to delays, product recalls, or rejection by regulatory bodies. Therefore, a systematic approach to design, verification, and documentation is critical for success in the medical device industry.

VTC helps your medical electrical equipment to meet the following standard's requirements:

• ANSI/AAMI ES 60601-1, IEC 60601-1, EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-6, EN 60601-1-6 Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability.
• ANSI/AAMI/IEC 60601-1-8, IEC 60601-1-8, EN 60601-1-8 Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
• ANSI/AAMI HA60601-1-11, IEC 60601-1-11, EN 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60601-2-2, EN 60601-2-2 及 CSA C22.2 NO. 60601-2-2:19 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• IEC 60601-2-10, EN 60601-2-10  Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators
• IEC 60601-2-24, EN 60601-2-24 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
• IEC 60601-2-25, EN 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• IEC 60601-2-27, EN 60601-2-27 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
• IEC 60601-2-41, EN 60601-2-41 Medical electrical equipment - Part 2-41: Particular requirementsfor the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
• IEC 60601-2-46, EN 60601-2-46 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
• IEC 60601-2-47, EN 60601-2-47 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
• IEC 60601-2-52, EN 60601-2-52 Medical electrical equipment - Part 2-52: Particular requirementsfor the basic safety and essential performance of medical beds
• ANSI/AAMI/IEC 62366-1, IEC 62366-1, EN 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices
• ANSI/AAMI EC12 Disposable ECG electrodes
• ANSI/AAMI NS4 Transcutaneous electrical nerve stimulators
• ANSI/AAMI EC53 ECG trunk cables and patient leadwires
• UL 61010-2-101, IEC 61010-2-101, EN 61010-2-101 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment