Hengyi HY-0580FR Biomechanical Testing System
| Brand | Hengyi |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | HY-0580FR |
| Instrument Type | Electromechanical Universal Testing Machine |
| Load Capacity Options | 1N–5000N (multi-range selectable) |
| Accuracy Class | ≤0.5% |
| Effective Test Width | 120 mm |
| Vertical Test Space | 800 mm |
| Speed Range | 0.001–500 mm/min |
| Speed Accuracy | ±0.5% of reading |
| Displacement & Strain Measurement Accuracy | ±0.5% of reading |
| Force Resolution | ±500,000 counts (full-scale, no range switching) |
| Control Mode | Digital open/closed-loop controller with multi-language/multi-unit support |
| Actuation | Panasonic servo motor + precision preloaded ball screw |
| Load Cell | U.S.-imported bidirectional load cell with auto-recognition |
| Safety | Electronic limit protection, overload protection (110% FS), automatic shutdown on preset time/force/displacement, real-time system diagnostics |
| Power Supply | 220 V AC, 750 W |
| Dimensions (W×D×H) | 470 × 400 × 1510 mm |
| Weight | 95 kg |
Overview
The Hengyi HY-0580FR Biomechanical Testing System is a high-precision electromechanical universal testing machine engineered for static mechanical characterization of biological and synthetic materials under tension, compression, bending, shear, peel, tear, and cyclic loading conditions. Based on ISO 527, ASTM D638, D790, D3039, and ISO 6892-1 compliant force-displacement transduction architecture, the system employs a rigid single-column frame, preloaded recirculating ball screw drive, and closed-loop digital control to deliver repeatable, traceable mechanical data across a broad spectrum of specimen geometries and compliance regimes. Its design prioritizes low-noise force measurement, minimal thermal drift, and high positional fidelity—critical for regulatory-grade biomechanical evaluation in medical device R&D, biomaterial certification, and pharmaceutical packaging validation.
Key Features
- Single-column structural frame with high rigidity and minimized deflection (<0.02 mm under full-load compression), optimized for compact laboratory integration without compromising mechanical stability.
- Panasonic AC servo motor and driver system (Japan-sourced), maintenance-free operation with torque consistency over >10,000 hours of cumulative runtime.
- Imported high-precision preloaded ball screw (C5 grade) ensuring axial backlash < 0.005 mm and lifetime repeatability within ±0.1% of full scale.
- U.S.-manufactured bidirectional load cell with integrated auto-identification circuitry; supports seamless calibration verification and sensor interchange without manual coefficient entry.
- Digital controller with configurable open/closed-loop modes, real-time PID tuning, and native support for SI, imperial, and CGS units—switchable via front-panel interface or remote software.
- Ergonomic handheld pendant with tactile feedback buttons for jog, start/stop, and emergency halt—designed for glove-compatible operation in cleanroom or biosafety environments.
Sample Compatibility & Compliance
The HY-0580FR accommodates specimens ranging from sub-millimeter biomedical sutures and vascular grafts to rigid orthopedic composites and photovoltaic interconnect ribbons. Standardized fixtures—including tensile grips (pneumatic and wedge-type), compression platens, 3-/4-point bend assemblies, peel bars, and puncture probes—enable direct alignment with ISO 13485, USP , and FDA 21 CFR Part 11 requirements for audit-ready test execution. All hardware complies with CE Machinery Directive 2006/42/EC and meets electromagnetic compatibility (EMC) standards per EN 61326-1. Optional accessories—such as video extensometry, environmental chambers (-40°C to +150°C), and GLP-compliant electronic signature modules—extend qualification readiness for ISO/IEC 17025-accredited laboratories.
Software & Data Management
Bundled HengyiTest v5.x software provides ISO 17025-aligned test method templates, automated report generation (PDF/Excel), and built-in audit trail functionality—including user login timestamps, parameter change logs, and raw-data immutability flags. Raw force-displacement curves are stored in .tdms format (NI-compatible) with embedded metadata (operator ID, calibration certificate ID, ambient temperature/humidity). The system supports optional 21 CFR Part 11 compliance packages featuring role-based access control, electronic signatures, and encrypted database archiving. Export protocols include ASTM E1434-compliant ASCII output for third-party statistical analysis (e.g., JMP, Minitab) and direct LIMS integration via HL7 or REST API.
Applications
- Biomedical device testing: suture tensile strength (ASTM D2256), stent radial strength (ISO 25539-2), catheter kink resistance (ISO 11357), and tissue-engineered scaffold compressive modulus.
- Pharmaceutical packaging: peel strength of blister lidding (ASTM F88), seal integrity of pouches (ASTM F1140), and puncture resistance of IV bags (ISO 8536-4).
- Advanced materials R&D: fracture toughness of hydrogels, viscoelastic recovery of shape-memory polymers, and interlaminar shear strength of carbon-fiber laminates (ASTM D2344).
- Quality control in electronics manufacturing: tensile yield of solar ribbon welds (IEC 61215), flexural rigidity of flexible PCB substrates, and adhesion strength of conductive pastes.
FAQ
What standards does the HY-0580FR comply with for medical device mechanical testing?
The system conforms to ISO 13485 Annex C for test equipment qualification and supports execution of ASTM F2100 (face mask filtration), ISO 7198 (vascular prostheses), and EN ISO 14243-1 (hip joint simulators) through validated fixture configurations and documented uncertainty budgets.
Can the system be integrated into an existing LIMS or QMS platform?
Yes—via optional HL7 v2.5 messaging or secure RESTful API endpoints. Full traceability includes sample ID mapping, test sequence logging, and digital signature handshaking compatible with TrackWise, MasterControl, and Veeva Vault QMS.
Is third-party calibration and metrological certification available?
Hengyi provides NIST-traceable calibration certificates (ISO/IEC 17025 accredited labs) upon request, including uncertainty statements per GUM (JCGM 100:2008) and annual recalibration reminders synchronized with internal QA schedules.
How is data integrity ensured during long-duration creep or fatigue tests?
The controller implements dual-buffered acquisition at 1 kHz sampling rate with battery-backed RAM retention. Power failure triggers automatic save-to-SSD with timestamped recovery points—no data loss beyond the last 200 ms of active acquisition.
Are custom fixture designs supported for non-standard specimens?
Yes—Hengyi’s engineering team offers CAD-supported custom fixture development (GD&T-compliant drawings, material certifications, and FEA stress reports) with lead times under 15 business days for prototypes.
