SumSpring GXY-02 Medical Needle Rigidity Tester
| Brand | SumSpring |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | GXY-02 |
| Force Sensor Range | 200 N |
| Displacement Resolution | 0.001 mm |
| Deflection Measurement Range | 0–5 mm |
| Accuracy | ±0.01 mm (deflection), ±0.1 N (load), ±0.5 mm (span adjustment) |
| Specimen Span Adjustment | 0–55 mm |
| Needle Outer Diameter Compatibility | 0.3–3.4 mm (normal, thin, and ultra-thin wall) |
| Loading Speed | 1 mm/min ±0.1 mm/min |
| Dimensions | 460 × 340 × 400 mm |
| Weight | 25 kg |
| Operating Temperature | 5–40 °C |
| Relative Humidity | 45–80% RH (non-condensing) |
| Power Supply | 220 V ±22 V, 50 Hz ±11 Hz |
Overview
The SumSpring GXY-02 Medical Needle Rigidity Tester is a precision mechanical testing instrument engineered for the quantitative assessment of flexural rigidity in stainless steel hypodermic needle tubing used in disposable medical devices. It operates on the principle of three-point bending: a standardized axial load is applied at the midpoint of a horizontally supported needle segment, and the resulting deflection (vertical displacement) is measured with high-resolution displacement transduction. This method directly evaluates structural stiffness—critical for ensuring safe insertion performance, resistance to buckling during clinical use, and compliance with international material and device standards. The instrument adheres to core biomechanical test paradigms defined in ISO 7864, ISO 9626, and pharmacopoeial specifications referenced in GB 18457–2015, YBB00092004–2015, and GB 15811–2001.
Key Features
- Integrated dual-sensor architecture: 200 N load cell with ±0.1 N accuracy and high-stability linear displacement sensor (0.001 mm resolution)
- Motor-driven, programmable loading actuator with closed-loop speed control (1 mm/min ±0.1 mm/min)
- Dual-mode operation interface: responsive 7-inch capacitive touchscreen + tactile physical keypad for glove-compatible or low-light lab environments
- Adjustable support span (0–55 mm, ±0.5 mm repeatability) accommodates needles from 0.3 mm to 3.4 mm outer diameter—including normal, thin, and ultra-thin wall configurations
- Automated data logging and statistical reporting: calculates and exports maximum, minimum, and mean deflection values across user-defined replicate tests
- Role-based access control system compliant with pharmaceutical quality management expectations (e.g., ALCOA+ principles), supporting audit-ready operation in GLP/GMP-regulated facilities
Sample Compatibility & Compliance
The GXY-02 is validated for testing stainless steel needle tubing intended for intradermal, subcutaneous, intramuscular, and intravenous applications—including IV catheters (over-the-needle and short peripheral), pre-filled syringe needles, anesthesia needles, and blood collection sets. Its mechanical design conforms to the dimensional and procedural constraints specified in GB 18457–2015 (Manufacturing Stainless Steel Needle Tubing for Medical Devices), YBB00092004–2015 (Stainless Steel Injection Needles for Prefilled Syringes), and GB 15811–2001 (Sterile Disposable Hypodermic Needles). While not certified to ISO/IEC 17025, the instrument’s traceable calibration protocol supports alignment with ISO 13485 quality system requirements when integrated into manufacturer-controlled validation processes.
Software & Data Management
Data acquisition and analysis are handled via embedded firmware with real-time graphical display of force–displacement curves. Test parameters—including span length, target load, dwell time, and number of cycles—are stored per test sequence with timestamped metadata. Export options include CSV files compatible with LIMS integration and PDF reports containing raw data tables, statistical summaries, and operator identification. Audit trail functionality records all parameter changes, user logins, and result modifications—meeting foundational expectations for data integrity under FDA 21 CFR Part 11 (when paired with appropriate organizational controls and electronic signature policies).
Applications
- Quality control release testing of stainless steel needle tubing prior to assembly into final devices
- Design verification and material qualification during new product development (e.g., evaluating alternative alloys or wall thickness profiles)
- Comparative rigidity benchmarking across supplier lots or manufacturing batches
- Root cause analysis of clinical failure modes related to needle deformation or insertion resistance
- Supporting regulatory submissions requiring mechanical performance evidence (e.g., 510(k), CE Technical File, PMDA dossier sections)
FAQ
What standard test method does the GXY-02 implement?
It follows the three-point bending configuration described in GB 18457–2015 Section 6.5 and ISO 9626 Annex B, applying a defined static load at the center of a supported span and measuring resultant deflection.
Can the instrument test needles with non-circular cross-sections?
No—the GXY-02 is calibrated and validated exclusively for round-section stainless steel hypodermic tubing. Non-circular geometries require custom fixturing and method validation beyond standard operation.
Is external calibration certification included with purchase?
The unit ships with factory calibration documentation. Users must perform periodic verification using NIST-traceable force and displacement standards as part of their internal equipment qualification program.
Does the GXY-02 support automated pass/fail evaluation against specification limits?
Yes—upper and lower deflection thresholds can be configured per test method; the system flags out-of-spec results in real time and logs them with contextual metadata.
