背景

WY-013 Breaking force and connection firmness tester

2026-04-13 14:19

Product Introduction of WY-013 Breaking Force and Connection Firmness Tester

The WY-013 Breaking Force and Connection Firmness Tester is a professional mechanical testing device independently developed by Jinan Vieleader Instruments Co., Ltd. specifically for the quality inspection of medical infusion devices. Designed in strict compliance with industry standards such as YY 0321, it is mainly used for the accurate detection of catheter breaking force, connector firmness, and the connection stability between needle hubs and needle tubes/ plunger rods and plunger seats of single-use sterile syringes, injection needles, catheters, infusion tubes and other medical devices. As a core testing equipment for medical device manufacturers, quality inspection institutions and scientific research units to control the mechanical safety performance of products, it effectively prevents potential safety risks such as fracture, falling off and separation during clinical application.

I. Core Positioning and Application Value

In the quality system of medical infusion devices (syringes, indwelling needles, infusion catheters, puncture needles, etc.), breaking force and connection firmness are key indicators directly determining clinical safety. Catheter fracture may lead to in-vivo residue and vascular embolism; loose connections between needle hubs and needle tubes, as well as between connectors and tubes, can cause serious medical accidents such as drug leakage, air embolism and device failure. By simulating the actual stress scenarios in clinical practice, the WY-013 applies precisely controlled axial tensile force to samples, quantitatively measures the peak force at the moment of fracture and the connection stability under load-holding conditions. It provides authoritative and traceable mechanical data support for product R&D, process optimization, factory quality inspection and compliance certification. Fully meeting the testing requirements of domestic mandatory standards including YY 0321, GB 15811, YY/T 0285 and relevant international ISO standards, it solves the pain points of low accuracy, unreliable data and low efficiency of traditional manual testing, realizing the standardization, automation and intelligence of mechanical performance testing for medical devices.

II. Core Working Principle

The instrument works based on the collaboration of high-precision tension sensing technology + PLC programmable control + servo drive system. The core force measurement unit adopts a high-sensitivity and high-stability resistance strain gauge force sensor, which accurately converts mechanical tension signals into electrical signals. After signal amplification and analog-to-digital conversion, the signals are transmitted to the control system. The 7-inch color touch screen serves as the core of human-computer interaction, supporting users to visually set test modes (breaking force/connection firmness), force range, stretching speed, load-holding time, sample specifications and other parameters. The PLC controller drives the servo motor to drive the precision lead screw transmission mechanism, stretching the sample at a constant speed, collecting force and displacement data in real time, and dynamically displaying the force-displacement curve. In the breaking force mode, it automatically captures and locks the peak force at the moment of sample fracture; in the connection firmness mode, it holds the set force/displacement for a specified time and automatically judges whether there is loosening, separation or leakage at the connection. The whole process automatically completes testing, data storage, result judgment and report output, ensuring the accuracy, stability and repeatability of the testing process.

III. Core Technical Parameters (Precisely Adapted to Medical Device Testing)

  1. Force Measurement: Range 0~100N (customizable to 0~300N), measurement accuracy ±1%, force resolution 0.01N, meeting the accurate detection of small force values for thin-specification catheters and micro-injection needles.

  2. Displacement Control: Stroke 0~200mm, displacement resolution 0.01mm, stretching speed 1~500mm/min stepless adjustable. Standard test speeds of 50mm/min and 500mm/min can be called with one key, with speed error ≤±2%.

  3. Control System: 7-inch high-definition color touch screen, Chinese visual menu, PLC+ARM dual-core control, supporting parameter preset, power-off memory, overload protection and automatic calibration.

  4. Test Modes: One-key switching between two modes — breaking force test (stretching until fracture and recording peak force), connection firmness test (constant force load-holding/constant displacement load-holding and judging connection stability).

  5. Data Processing: Built-in storage, capable of saving ≥1000 sets of test data, supporting real-time printing of test reports (including force, displacement, time and result judgment) via on-board micro-printer, and data can be exported to computers for in-depth analysis.

  6. Fixture Configuration: Standard medical-specific flexible fixtures, suitable for various samples such as syringe barrels, plunger rods, injection needles, catheters and Luer connectors, with damage-free clamping and uniform force bearing, avoiding data distortion caused by sample slipping or local stress concentration.

  7. Environment and Power Supply: Operating temperature 15℃~50℃, relative humidity ≤80% (no condensation), power supply AC220V±10%/50Hz, overall dimensions 310mm×400mm×800mm, net weight 28Kg. Desktop design for easy installation and small space occupation.

IV. Core Product Advantages

  1. Standard Compliance and Authoritative Testing: Fully compliant with mandatory standards for medical devices such as YY 0321, GB 15811 and YY/T 0285. The testing methods, parameter settings and result judgments are completely consistent with standard requirements. Test data can be directly used for product registration, quality certification and factory release, avoiding compliance risks.

  2. High Precision and Stable Data: Adopting imported core force sensors, combined with precision transmission and closed-loop control, the instrument features minimal errors in force and displacement measurement and high repeatability of test results. It solves the problems of large data drift and poor repeatability of manual testing and simple equipment, ensuring that each test result truly reflects the mechanical performance of samples.

  3. Intelligent Operation and High Efficiency: Full touch screen visual operation, no complicated programming required, easy for beginners to master quickly. Supporting parameter preset, one-key start, automatic testing, automatic judgment and automatic printing, the testing of a single sample only takes tens of seconds, greatly improving quality inspection efficiency and suitable for batch factory inspection scenarios.

  4. Comprehensive Functions and Strong Adaptability: The two core test modes cover the two key testing items of breaking force and connection firmness. Equipped with standard multi-specification special fixtures, it can quickly switch to test various medical infusion devices such as syringes, injection needles, indwelling needles, infusion catheters, Luer connectors and extension tubes, realizing multiple testing needs with one device.

  5. Safe, Stable and Easy Maintenance: Equipped with triple safety mechanisms of overload protection, overcurrent protection and limit protection to prevent equipment damage caused by sample fracture impact and misoperation. The power-off memory function can resume the test progress after unexpected power failure. The whole machine adopts a modular design, with core components having a long service life. Daily maintenance only requires simple cleaning, no frequent calibration needed, reducing operating costs.

V. Typical Application Scenarios

  1. Factory Quality Inspection for Manufacturers: Factory quality testing of single-use sterile syringes, injection needles, infusion sets, indwelling needles, central venous catheters and other products, batch screening of unqualified products with insufficient breaking force and loose connections, ensuring 100% compliance of ex-factory products with standards.

  2. R&D and Process Optimization: During the R&D stage of medical devices, testing the mechanical properties of samples with different materials and bonding/injection molding processes, comparing data to optimize formulas, structures and production processes, and improving product reliability.

  3. Third-Party Testing Institutions: Providing third-party mechanical performance testing services for medical device enterprises, issuing authoritative test reports to support product registration, bidding and tendering, and quality dispute judgment.

  4. Scientific Research and Teaching: Conducting research on the mechanical properties of medical polymer materials and device connection processes in universities and scientific research institutes, as well as teaching and training of medical device quality testing, providing a standardized experimental platform.

VI. Brief Operation Process

  1. Preparation: Power on and preheat the instrument, calibrate force and displacement, install special fixtures corresponding to the samples.

  2. Parameter Setting: Select the test mode (breaking force/firmness) on the touch screen, input sample specifications, set stretching speed, force/displacement and load-holding time.

  3. Sample Loading: Clamp the sample stably between the upper and lower fixtures to ensure the sample is vertical, free from distortion and under uniform force.

  4. Testing: Start with one key, the instrument automatically stretches at a constant speed, displays the force and displacement curve in real time. The breaking force mode automatically locks the peak value, and the firmness mode automatically judges the result after load-holding.

  5. Output: After the test is completed, view the data, save the record, print the test report with one key, and complete the detection of a single sample.


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