Hengyi HY-0580YUKMK Universal Testing Machine for Biomaterials

Overview

The Hengyi HY-0580YUKMK Universal Testing Machine is an electromechanical force-testing platform engineered for high-reproducibility mechanical characterization of biomaterials, medical devices, and soft/hard composite specimens under uniaxial tension, compression, bending, shear, peel, and puncture loading conditions. Built upon a rigid single-column alloy frame with dual-layer baked enamel finish, the system delivers structural stability and long-term dimensional integrity essential for GLP-compliant biomechanical testing. Its modular architecture supports standardized test configurations per ISO 13485–aligned quality systems and fulfills core requirements of FDA 21 CFR Part 11 when deployed with audit-trail-enabled software. The machine operates on a microprocessor-controlled servo drive system, enabling precise execution of multi-stage protocols—including creep, stress relaxation, cyclic loading, and rate-dependent ramp tests—across a dynamic speed range from 0.001 to 500 mm/min. Force transduction employs a high-linearity load cell calibrated to Class 0.5 accuracy (per ISO 7500-1), while displacement and strain are acquired via non-contact optical encoders and extensometer-compatible interfaces, ensuring traceable metrology across the full 5 N to 5000 N capacity spectrum.

Key Features

• Rigid single-arm aluminum-alloy chassis with enhanced torsional stiffness and vibration-damping geometry, optimized for low-noise operation in shared laboratory environments.
• Four independent closed-loop control modes: load, displacement, strain, and stress—each configurable with real-time PID tuning for specimen-specific response compensation.
• Full-range force resolution of ±500,000 digital counts without auto-ranging or internal gain switching, preserving signal fidelity across sub-mN to kN measurements.
• Integrated electronic limit protection, overload cutoff (>110% FS), and self-diagnostic routines for drive voltage, current, thermal load, and encoder feedback integrity.
• Motorized crosshead with dual-speed jog control (fast return + fine positioning), programmable stop triggers (load/strain/time-based), and automatic post-test return to home position.
• Modular accessory interface compliant with ISO 2041 and ASTM E1012 standards, supporting interchangeable grips (pneumatic, wedge, vise), environmental chambers (-40°C to +200°C), and digital video extensometry add-ons.

Sample Compatibility & Compliance

The HY-0580YUKMK accommodates heterogeneous specimen geometries—from micro-scale hydrogel films (≥1 mm width) to macro-scale orthopedic implants (e.g., femoral stems, spinal cages). Validated applications include tensile testing of collagen scaffolds (ASTM F2128), suture loop strength (ISO 10993-12), stent radial force (ASTM F2082), catheter burst pressure (ISO 8536-4), and peel adhesion of sterile packaging (ASTM F88). All hardware and firmware comply with GB/T 16491–2008 (Chinese national standard for electronic UTM), and mechanical validation reports reference ISO 7500-1 (static calibration) and ISO 5893 (dynamic performance). Optional documentation packages support GMP facility audits, including IQ/OQ protocols, uncertainty budgets per EURAMET cg-18, and raw data export in CSV/Excel formats compatible with LIMS integration.

Software & Data Management

The embedded Windows-based control suite provides real-time graphical display of force–displacement, stress–strain, and time-series curves with overlay capability for comparative analysis. Data acquisition occurs at ≥1 kHz sampling rate, with timestamped metadata (operator ID, sample ID, environmental conditions, calibration certificate ID) embedded in each dataset. Export options include PDF test reports (customizable templates), XML for ELN ingestion, and ASCII for MATLAB/Python post-processing. Audit trail functionality logs all user actions—including method edits, calibration events, and result deletions—with immutable timestamps and operator authentication. Software validation documentation is available upon request for regulated environments requiring 21 CFR Part 11 compliance.

Applications

• Mechanical evaluation of native and engineered soft tissues: tendon, ligament, skin, intestinal mucosa, and decellularized extracellular matrix scaffolds.
• Characterization of resorbable polymers (PLA, PCL, PGA) and bioactive ceramics (hydroxyapatite, tricalcium phosphate) under physiological hydration states.
• Functional testing of minimally invasive devices: guidewires, balloon catheters, embolization coils, and endoscopic clip appliers.
• Quality control of primary packaging: blister seal strength, ampoule break-loose force, syringe plunger glide resistance, and IV bag puncture integrity.
• Biomechanical validation of dental restoratives, orthodontic wires, and osseointegrated abutments per ISO 14801 and ISO 22674.
• Regulatory submission support for ISO 10993 biocompatibility dossiers, particularly mechanical endpoints in Part 6 (physical testing) and Part 12 (sample preparation).

FAQ

What standards does the HY-0580YUKMK support for medical device testing?
It natively executes test methods aligned with ASTM F2128 (sutures), ISO 14801 (dental implants), ISO 10993-12 (sample preparation), and ISO 527 (plastics tensile testing), with configurable parameter sets for each.
Can the system be integrated into a validated LIMS or MES environment?
Yes—via OPC UA or TCP/IP API, supporting structured data exchange with LabWare, Thermo Fisher SampleManager, and Siemens Opcenter Execution.
Is third-party calibration certification included with purchase?
A factory-issued ISO/IEC 17025 calibration certificate (traceable to NIM, China) is provided; annual recalibration services are available through Hengyi’s CNAS-accredited service centers.
Does the machine support high-humidity or saline immersion testing?
When paired with optional environmental enclosures and corrosion-resistant grips, it supports ASTM F2129 (electrochemical corrosion) and ISO 10993-15 (wear debris quantification) protocols.
What is the warranty coverage and service response time?
Standard coverage includes 24 months parts-and-labor warranty; priority on-site technical support is available within 72 business hours in Tier-1 Chinese cities and 5 business days internationally.