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IEC60601-1 Figure 8 Test Pin

Product No: SMT-1213

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  • Description
  • The IEC 60601-1 Figure 8 Test Pin is a critical safety tool designed exclusively for medical electrical equipment—including patient monitors, ultrasound machines, and infusion pumps. It’s engineered to test the accessibility of hazardous internal parts (e.g., live wires, high-voltage components) and verify compliance with IEC 60601-1’s strict protective enclosure requirements for patient and user safety. Featuring a precision-machined conductive stainless steel tip (shaped to mimic accidental contact) and an insulated handle, it detects electrical contact with dangerous components while keeping testers safe. Strictly aligned with IEC standards, it’s durable, accurate, and essential for medical device manufacturers to meet global regulatory compliance.

    NOTE: Please note SMT-1213 is without cable. If you want to test with Low-voltage Test Supply LISUN model is SMT-529CV, you may choose SMT-1213C with cables. 

    Standards:

    Standards No. Clause/Figure Standards Name
    IEC 60601-1:2020 Clause 8.1.3, Figure 8 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
    UL 60601-1:2023 Clause 8.1.3, Figure 8 Standard for Safety for Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
    EN 60601-1:2020 Clause 8.1.3, Figure 8 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

    Specifications:
    Tool Type: IEC 60601-1 Figure 8 Test Pin (for medical electrical equipment hazardous part accessibility testing)
    Tip Material: Stainless steel (highly conductive, resistance ≤ 0.1Ω; corrosion-resistant; precision-shaped to match IEC 60601-1 Figure 8)
    Handle Material: High-temperature resistant plastic (insulated, resistance ≥ 100MΩ; ergonomic grip for precise operation; safe for medical device testing environments)
    Key Dimensions:
    – Tip Diameter: 5mm ± 0.05mm (per IEC 60601-1 specifications)
    – Tip Length: 80mm ± 0.2mm
    – Handle Length: 120mm ± 0.5mm
    – Total Length: 200mm ± 0.5mm
    Applied Force: 1N ± 0.1N (standard for medical device accessibility testing; mimics light accidental contact by users/patients)
    Core Function:Detects accessibility of hazardous live parts in medical electrical equipment; ensures enclosures meet IEC 60601-1’s basic safety requirements

    Test Procedures:
    1. Inspect the test pin (no bent tip, damaged insulation, or poor conductivity) and connect it to a medical-grade contact detection instrument.
    2. Power on the medical device under test (MDUT) and set it to normal operating mode (e.g., patient monitoring mode).
    3. Hold the insulated handle (avoid touching the conductive tip) and align the tip with MDUT enclosure openings (e.g., port slots, vent gaps, control seams).
    4. Insert the tip into the opening with a steady 1N force—advance until resistance is felt or the tip reaches its full insertion depth.
    5. Check the detection instrument for signals (indicating contact with hazardous live parts).
    6. Record results: pass if no contact detected; fail if live part contact is confirmed (requiring enclosure redesign).

    Applications:
    1. Accessibility testing of patient monitors (e.g., ECG machines) per IEC 60601-1:2020 Figure 8 to protect patients from live component exposure.
    2. Safety checks for diagnostic ultrasound machines (transducer ports and control panels) compliant with UL 60601-1:2023.
    3. Verification of infusion pumps (tubing access slots and power button gaps) to meet EN 60601-1:2020’s basic safety standards.
    4. Quality control for portable medical devices (e.g., blood glucose meters) during manufacturing to ensure user safety.
    5. Post-production testing of hospital-grade ventilator enclosures to comply with global medical device regulatory requirements.

    IEC60601-1 Figure 8 Test Pin

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