Hengyi HY-0350 Suture Tensile Testing Machine
| Brand | Hengyi / Hengyitest |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | HY-0350J |
| Instrument Type | Electromechanical Tensile Testing Machine |
| Maximum Test Load | 3 kN |
| Load Measurement Range | 0.001% FS |
| Load Accuracy | ±0.5% |
| Stroke | 500 mm |
| Displacement Resolution | 0.001 mm |
| Speed Range | 0.001–500 mm/min |
| Speed Accuracy | ±0.5% |
| Displacement Accuracy | ±0.5% |
| Safety Features | Electronic Limit Switches, Emergency Stop Button |
| Weight | ~75 kg |
| Dimensions (W×D×H) | 460 × 430 × 1100 mm |
| Power Supply | AC 220 V |
Overview
The Hengyi HY-0350 Suture Tensile Testing Machine is a precision-engineered electromechanical universal testing system designed specifically for the mechanical characterization of surgical sutures and other fine biomedical filaments. It operates on a closed-loop servo-controlled architecture, where a high-torque DC motor drives a precision ball-screw actuator to deliver controlled axial displacement. Force is measured via a calibrated load cell with digital signal processing (DSP) conditioning, enabling real-time acquisition of tensile force, elongation, and deformation data. The system complies with core biomechanical test requirements defined in ISO 10993-12, ASTM D2256 (for tensile properties of yarns), and USP (mechanical testing of medical devices), supporting both static and dynamic loading protocols up to 3 kN. Its modular design integrates seamlessly into GLP-compliant laboratory environments and meets foundational structural and electrical safety criteria per IEC 61000-6-2 (EMC immunity) and IEC 61010-1 (safety of laboratory equipment).
Key Features
- High-resolution displacement measurement: 0.001 mm resolution over a 500 mm effective stroke, with optional extended travel configurations available upon request.
- DSP-based real-time control platform ensuring deterministic response time (<10 ms loop cycle), superior noise rejection, and stable low-speed operation down to 0.001 mm/min.
- USB 2.0–compatible interface (backward-compatible with USB 1.1 at 12 Mb/s full-speed mode) enabling plug-and-play connectivity with Windows XP through Windows 11 systems.
- Four-layer PCB controller board with optimized grounding and differential signal routing to minimize electromagnetic interference during sensitive low-load measurements (e.g., absorbable monofilament suture testing).
- Multi-language software interface (HYtest V7.0) supporting nine languages and dual-unit display: force (N, kN, lbf, kp, kgf, tonf), displacement (mm, inch), and strain (%).
- Comprehensive safety architecture including programmable electronic limit switches, hardware-triggered emergency stop circuitry, and overload cutoff protection rated to 150% of full-scale capacity.
- Aluminum alloy frame construction with anodized surface finish — corrosion-resistant, non-fading, and compliant with ISO 9223 classification for indoor industrial environments.
Sample Compatibility & Compliance
The HY-0350 accommodates suture specimens ranging from 3-0 to 12-0 gauge (USP diameter range: 0.02–0.80 mm), including monofilament, braided, coated, and absorbable polymer types (e.g., polyglycolic acid, polylactic acid, polydioxanone). Grip configurations support pneumatic, wedge, and custom jaw inserts with serrated or rubber-faced contact surfaces to prevent slippage during high-strain-rate tests. The system supports standardized test methods per ISO 7198 (cardiovascular implants), ASTM F2102 (suture knot strength), and YY/T 0661–2020 (Chinese standard for surgical suture tensile performance). All firmware and software modules are structured to support audit-ready data integrity: timestamped raw data logging, operator ID tagging, and immutable test record generation compatible with FDA 21 CFR Part 11–aligned validation packages.
Software & Data Management
HYtest V7.0 is a SQL Server–backed desktop application developed in VB.NET, delivering deterministic data handling and traceable parameter configuration. It enables real-time plotting of stress–strain, load–displacement, and creep/recovery curves with auto-scaling axes, manual zoom/pan, and point-of-interest annotation (e.g., yield point, ultimate tensile strength, elongation at break). Users may define custom test sequences—including preload conditioning, ramp-hold cycles, and fracture detection thresholds—via intuitive drag-and-drop workflow editors. Raw data exports to CSV, XML, and PDF formats include metadata headers (test date, operator, calibration ID, environmental conditions). Audit trail functionality logs all user actions, parameter changes, and report generations with SHA-256 hashing for tamper evidence—essential for ISO/IEC 17025 accredited laboratories and regulatory submissions.
Applications
This instrument serves quality control and R&D laboratories across regulated medical device manufacturing, contract testing organizations (CTOs), and academic biomaterials research groups. Typical use cases include: comparative evaluation of suture tensile strength before/after sterilization (EtO, gamma, e-beam); cyclic fatigue testing of knot security under physiological loading; degradation profiling of resorbable sutures in simulated body fluid (SBF); compliance verification against EN 455–2 (medical gloves) and ISO 13485 production process validation requirements; and mechanical benchmarking of novel bioengineered filament materials. Its adaptability extends to non-medical applications such as tensile analysis of micro-cables, textile filaments, thin films, and elastomeric seals where sub-newton sensitivity and micron-level displacement fidelity are critical.
FAQ
What standards does the HY-0350 comply with for suture testing?
It supports method execution per ISO 7198, ASTM F2102, ASTM D2256, YY/T 0661–2020, and USP , with configurable test templates preloaded in HYtest V7.0.
Can the system be validated for GMP/GLP environments?
Yes — the software includes electronic signature capability, audit trail export, and IQ/OQ documentation templates aligned with FDA 21 CFR Part 11 and EU Annex 11 requirements.
Is third-party calibration certification available?
Hengyi provides NIST-traceable calibration certificates for load cells and displacement encoders, with optional UKAS or CNAS accreditation upon request.
What maintenance is required for long-term accuracy?
Routine tasks include periodic lubrication of the ball screw with lithium-based grease (mixed with light machine oil), cleaning of optical encoder paths, and biannual verification of load cell linearity and zero drift per ISO 376.
Does the machine support automated batch testing?
Yes — HYtest V7.0 allows scripting of unattended multi-specimen runs with automatic result aggregation, statistical summary (mean, SD, CV%), and pass/fail flagging against user-defined specification limits.
