Hengyi HY-0580UING Medical Syringe Plunger Pull-Out Force Tester
| Brand | Hengyi / Hengyitest |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Regional Category | Domestic (China) |
| Model | HY-0580UING |
| Instrument Type | Electromechanical Universal Testing Machine |
| Price Range | USD 1,400 – 7,200 (FOB Shanghai) |
| Accuracy Class | ≤ 0.5% of full scale |
| Rated Load Options | 1 N to 5,000 N (interchangeable load cells) |
| Effective Force Resolution | ±500,000 counts (no internal range switching) |
| Test Width | 120 mm |
| Vertical Test Space | 800 mm |
| Speed Range | 0.001–500 mm/min (programmable, ±0.5% speed accuracy) |
| Displacement & Strain Measurement Accuracy | ±0.5% of reading |
| Stress/Strain Control Rate Range | 0.002–6% FS/s |
| Constant-Load/Displacement/Strain Hold Accuracy | ±0.1% FS (≥10% FS), ±1% FS (<10% FS) |
| Safety Features | Electronic travel limit, overload protection (110% FS), real-time system diagnostics |
| Power Supply | 220 V AC, single-phase, 750 W |
| Net Weight | 120 kg |
| Dimensions (W×D×H) | 470 × 400 × 1510 mm |
Overview
The Hengyi HY-0580UING Medical Syringe Plunger Pull-Out Force Tester is a precision-engineered electromechanical universal testing machine designed specifically for quantitative mechanical evaluation of medical device components—most critically, the plunger-to-barrel retention force in disposable syringes. Built upon a rigid single-column benchtop architecture, it operates on the principle of controlled uniaxial tensile displacement, applying calibrated axial force while simultaneously recording real-time load, displacement, and strain data. Its core function aligns with ISO 11040-4 (Syringes for single use), ISO 7886-1 (Sterile hypodermic syringes), and USP (Package Integrity Evaluation), where plunger pull-out force must remain within strict upper and lower thresholds to ensure both sterility maintenance and clinical usability. The system satisfies metrological traceability requirements per ISO/IEC 17025 and supports GLP-compliant audit trails when configured with validated software modules.
Key Features
- High-rigidity single-column frame with vibration-damped base, minimizing parasitic deflection during low-force measurements (e.g., 1–50 N syringe tests).
- Precision ground ball-screw drive system coupled with Panasonic AC servo motor—ensuring smooth motion control, low acoustic emission (<65 dB), and long-term repeatability (CV < 0.8% at 10 N over 50 cycles).
- Multi-range load cell compatibility: Interchangeable transducers from 1 N to 5,000 N (e.g., Transducer Technologies or Interface OEM variants), each certified to ISO 376 Class 0.5.
- True triple-closed-loop control: Independent feedback loops for force, displacement, and strain enable precise ramp-hold-step protocols required by ASTM D638, ISO 527, and GB/T 1040.
- Real-time diagnostic subsystem continuously monitors power supply voltage, current draw, encoder signal integrity, and load cell bridge balance—triggering automatic shutdown upon deviation beyond IEC 61000-4-5 surge immunity thresholds.
- Integrated electronic travel limit switches and programmable emergency stop logic compliant with EN ISO 13857 safety distances for operator protection.
Sample Compatibility & Compliance
The HY-0580UING accommodates standardized syringe fixtures per ISO 11040-4 Annex B (plunger rod clamping jaws) and custom tooling for Luer-lock, slip-tip, and auto-disable syringes. Beyond syringes, it supports tensile testing of catheter shafts (ISO 10555-1), IV tubing peel strength (ASTM D903), and packaging seal integrity (ASTM F88). All mechanical calibrations are traceable to NIM (National Institute of Metrology, China) or NIST-equivalent standards. The instrument meets essential requirements of the EU Machinery Directive 2006/42/EC and carries CE marking under harmonized standards EN ISO 12100 and EN 61000-6-2/6-3. Software validation packages support FDA 21 CFR Part 11 compliance—including electronic signatures, audit trail logging, and role-based access control.
Software & Data Management
The bundled Windows-based test platform (v3.2.x) offers dual-language UI (English/Chinese), preloaded test methods for ISO 7886-1 pull-out, GB/T 3923 textile tear, and ASTM D1876 T-peel. Users may define custom test sequences using a visual step editor—specifying ramp rates, dwell durations, break detection criteria (e.g., 10% load drop), and pass/fail tolerances. Raw data exports to CSV, XML, or PDF report formats include embedded metadata: operator ID, calibration certificate number, environmental conditions (optional sensor input), and timestamped digital signatures. Data archives are stored in AES-256 encrypted local databases; optional network backup to SQL Server or cloud S3 buckets is available via API integration.
Applications
- Quantification of plunger withdrawal force across 0.5 mL to 60 mL syringes under ambient and elevated temperature conditions (with optional environmental chamber).
- Evaluation of adhesive bond strength between silicone lubricant layers and glass/plastic barrel surfaces per ISO 15751.
- Mechanical characterization of drug-eluting stent crimping mandrels (radial compression) and balloon catheter burst pressure (via hydraulic adapter kit).
- Quality control of pharmaceutical blister pack peel strength (ASTM F88), pouch seal integrity (ASTM F1140), and child-resistant closure torque (ISO 8317).
- Academic research on polymer viscoelasticity—using dynamic load-relaxation protocols to derive Prony series coefficients for thermoplastic elastomers used in medical tubing.
FAQ
Does the HY-0580UING meet ISO 11040-4 requirements for syringe plunger pull-out testing?
Yes—the system’s force resolution (≤0.002% FS), speed stability (±0.5%), and fixture geometry comply with Clause 6.4.2 of ISO 11040-4. Calibration certificates include uncertainty budgets per GUM (JCGM 100:2008).
Can the instrument perform cyclic fatigue testing on needle hubs?
Yes—using the programmable sequence module, users can define up to 999,999 cycles with variable amplitude, frequency (0.01–5 Hz), and dwell time. Force reversal accuracy is ±0.3% FS.
Is third-party verification available for regulatory submissions?
Hengyi partners with CNAS-accredited labs (e.g., SGS Shanghai, BSI Guangzhou) to provide IQ/OQ/PQ documentation, including installation checklists, operational boundary mapping, and performance qualification against reference standards.
What is the warranty coverage and service response time?
Standard warranty: 24 months parts/labor. On-site technical support is available within 72 hours in Tier-1 Chinese cities; remote diagnostics and firmware updates are provided free of charge for the lifetime of the instrument.
How is data integrity ensured during long-duration creep tests?
The controller uses non-volatile FRAM memory for buffer storage, eliminating data loss during unexpected power interruption. All test sessions generate SHA-256 checksums logged alongside raw data files for forensic verification.
