Hengyi HY-0230L Medical Device Stapler Peel Strength Testing Machine
| Brand | Hengyi / Hengyitest |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Regional Category | Domestic (China) |
| Model | HY-0230L |
| Instrument Type | Electromechanical Universal Testing Machine |
| Load Capacity Options | 1N–2000N (multi-range selectable) |
| Accuracy Class | ≤0.5% of full scale |
| Effective Test Width | 120 mm |
| Effective Stroke | 300 mm |
| Speed Range | 0.001–300 mm/min (adjustable) |
| Speed Accuracy | ±0.5% of indicated value |
| Force Resolution | ±500,000 counts (full-scale, no range switching) |
| Displacement & Strain Measurement Accuracy | ±0.5% of indicated value |
| Stress/Strain Control Rate Range | 0.002–6% FS/S |
| Constant-Load/Displacement/Deformation Control Range | 0.5–100% FS |
| Protection Features | Electronic limit switch, overload protection (>110% FS), auto-diagnostic system |
| Power Supply | 220 V AC, single-phase, 200 W |
| Dimensions (W×D×H) | 430 × 315 × 855 mm |
| Weight | 40 kg |
Overview
The Hengyi HY-0230L Medical Device Stapler Peel Strength Testing Machine is a precision-engineered electromechanical universal testing system designed specifically for regulatory-compliant mechanical evaluation of surgical staplers, suture anchors, wound closure devices, and other implantable or single-use medical components. Built upon a rigid single-column load frame architecture, the HY-0230L implements ISO 7206-4, ASTM F1980, ISO 11607-2, and USP compliant static tensile, peel, shear, and compression methodologies. Its core measurement principle relies on closed-loop force feedback control via high-accuracy bidirectional load cells (±0.5% FS accuracy), coupled with real-time displacement and strain monitoring across a fully programmable speed range (0.001–300 mm/min). The system meets essential requirements for ISO 13485-certified quality laboratories and supports audit-ready documentation under FDA 21 CFR Part 11 when integrated with validated software.
Key Features
- Rigid single-column structural frame with preloaded high-precision ball screw and maintenance-free servo motor–driver assembly.
- Imported bidirectional load cell (rated capacities from 1 N to 2000 N; multiple transducers swappable within one frame).
- Digital controller supporting multi-language UI (English, German, French, Spanish, Chinese) and unit conversion (N, kN, lbf, kgf, MPa, psi).
- Integrated handheld remote control for rapid jog operation, emergency stop, and manual positioning.
- Electronic travel limit protection, overload cutoff (>110% FS), and automatic self-diagnostic routines for drive, load, and position subsystems.
- Programmable test termination modes: time-based, displacement-based, load-based, or deformation-based stopping criteria.
- Motorized crosshead with dual-speed (fast/slow) actuation and point-to-point manual return capability.
Sample Compatibility & Compliance
The HY-0230L accommodates standardized specimen geometries per ISO 11337 (staple line peel), ASTM F2458 (vascular staple burst strength), and ISO 22679 (dental adhesive bond strength). Validated applications include peel testing of tissue-adherent staples, lap-shear strength of bioresorbable sutures, compression testing of orthopedic fixation pins, and three/four-point bending of polymer-based implant housings. Compatible sample types span thin metallic foils (e.g., Ti-6Al-4V staples, NiTi clips), elastomeric sealants, hydrogel-coated meshes, sterilized packaging films (Tyvek®/PET/PE laminates), and biodegradable polymer strips (PLGA, PCL). All hardware configurations comply with GLP and GMP environmental controls when installed in ISO Class 7 cleanrooms or regulated QC labs.
Software & Data Management
The HY-0230L operates with Hengyi’s proprietary WinTest Pro v4.x software—validated for 21 CFR Part 11 compliance with electronic signatures, role-based access control, and immutable audit trails. Raw force–displacement data is acquired at ≥1 kHz sampling rate and stored in .tdms format (NI-compatible) with embedded metadata: operator ID, calibration timestamp, environmental conditions (optional sensor integration), and test method reference (e.g., “ISO 11337 Annex B”). Export options include CSV, PDF reports with annotated stress–strain curves, and XML for LIMS integration. Optional add-ons include automated report generation per MDR Annex II requirements and digital certificate management linked to Shanghai Institute of Measurement and Testing Technology (SIMT) calibration records.
Applications
- Peel strength quantification of linear and circular surgical staplers per ISO 11337 and AAMI ST91.
- Tensile integrity verification of absorbable suture knots and barbed suture anchoring strength.
- Compression yield analysis of porous bone graft substitutes and ceramic dental abutments.
- Shear resistance evaluation of pressure-sensitive adhesives used in transdermal patches and ECG electrodes.
- Cyclic fatigue assessment of micro-actuated implant delivery systems (500–10,000 cycles, ±0.1 mm amplitude).
- Mechanical validation of sterile barrier integrity in Class II/III device packaging per ISO 11607-2.
FAQ
Does the HY-0230L meet FDA submission requirements for 510(k) mechanical testing?
Yes — when operated with validated WinTest Pro software, calibrated traceable to SIMT/NIM, and documented per ISO 17025 procedures, the system satisfies FDA guidance on bench testing of surgical staplers (K190259).
Can the system perform dynamic fatigue testing?
It supports quasi-static cyclic loading (tension–compression, tension–tension) up to 10,000 cycles at frequencies ≤5 Hz; dedicated high-frequency servo-hydraulic systems are recommended for >10 Hz applications.
Is third-party IQ/OQ/PQ support available?
Hengyi provides factory-issued IQ/OQ protocols aligned with ASTM E2500 and offers PQ execution support through authorized regional partners certified under ISO/IEC 17025.
What calibration standards are applied to the load cell?
All transducers are calibrated against national primary standards maintained by SIMT (Shanghai) and accompanied by certificates showing uncertainty budgets per ISO/IEC 17025:2017.
How is data integrity ensured during long-duration creep tests?
WinTest Pro implements write-once-read-many (WORM) storage, checksum validation on every data packet, and timestamped operator annotations synchronized to GPS-referenced system clocks.
