Suture Needle Penetration and Bending Strength Tester
The Suture Needle Penetration and Bending Strength Tester is a device used to test the penetration performance and strength of medical suture needles. Designed and manufactured according to relevant standards ASTM F3014-2014 and ASTM F1874-98. this tester simulates the penetration process of a suture needle during actual use. Using a high-precision force sensor, it measures the force exerted on the needle tip as it penetrates simulated tissue, thereby evaluating the penetration performance and strength of the suture needle. It has wide applications in the medical, pharmaceutical, and quality control fields, and is crucial for ensuring the safety and effectiveness of surgical suturing procedures.
Applications
Quality Control for Manufacturing Enterprises: During the production of suture needles, the tester can conduct sampling tests on each batch of suture needles, promptly identifying quality issues in the production process, such as unstable raw material quality or defects in processing techniques. This enables timely adjustment of the production process to ensure the stability and consistency of product quality. Selecting Appropriate Suture Needles for Medical Institutions: Medical institutions can use the tester to conduct performance tests on different types of suture needles, and based on the test results, select the suture needles that best meet the surgical needs of patients, thereby improving surgical effectiveness and patient safety. Product R & D and Optimization: R & D personnel in the medical device field can use the tester to evaluate the performance of the design of new - type suture needles. By testing the strength and puncture force of suture needles with different structures, materials, and dimensions, they can optimize the design of suture needles and develop products with better performance.
Standards
The Suture Needle Puncture and Bending Strength Tester complies with relevant standards such as ASTM F3014 - 2014 and ASTM F1874 - 98. - ASTM F3014 - 2014: Specifies the specific methods and procedures for the penetration test of surgical suture needles, aiming to evaluate the penetration performance of suture needles to ensure they can meet requirements in actual use. - ASTM F1874 - 98: Specifies the specific methods and procedures for the bending test of surgical suture needles, aiming to evaluate the strength and durability of suture needles under bending conditions.
Technical Parameters
| Serial No. | Parameter Item | Parameter Details |
|---|---|---|
| 1 | Testing Items | Puncture force, bending strength |
| 2 | Range | Customizable according to actual needs (e.g., 0 - 50N) |
| 3 | Stations | Multiple stations (adjustable per test requirements; e.g., 12 stations) |
| 4 | Accuracy | High-precision sensor; indication error ≤ 0.01N or 0.1%FS (full-scale range) |
| 5 | Needle-clamping Fixture | Fixtures for holding suture needles (e.g., 4°±2°/s, etc.); ensures stability and accuracy of suture needles during testing |
| 6 | Speed | Adjustable per actual needs; minimum: 10cm/min (4in/min), maximum: 30.5cm/min (12in/min) |
| 7 | Testing Rate | Speed when loading to set value ≤ 10mm/s |
| 8 | Power Supply | Usually 220V 50Hz; or other voltages/frequencies complying with local electrical standards |
Accessoriess
1. One main unit
2. One roll of printing paper
3. One set of clamps
4. One set of weights
5. One-year warranty
6. Operating instructions
7. Free lifetime instrument upgrade service according to standard specifications
Features
Professional multi-station rotary testing system and bending strength testing system, suitable for puncture and bending strength testing of curved needles, straight needles, etc.
Simple and intuitive operation interface, convenient user-defined testing functions, and comprehensive data analysis and reporting functions.
Professional testing software with data analysis and reporting functions.
High-precision imported sensors for more accurate test results.
Real-time curve test data for easy identification of peaks and valleys.
The test platform has positioning holes for quick and accurate fixture installation.
Supports testing of various sample specifications; users can freely select different needle specifications.
Equipped with a handheld control box for quick adjustment of motor position.
Features automatic data storage and automatic power-off memory function.
Safety protection:
The software has an over-range pressure shutdown function to effectively protect the sensor.
Data security:
Equipped with a four-level user security password strategy to ensure the security of test data.
The computer software complies with GMP "Computerized Systems" requirements and has functions such as user management, permission management, and data audit trails.
FAQ
1. What is the main function of the Suture Needle Penetration and Bending Strength Tester?
The Suture Needle Penetration and Bending Strength Tester is used to evaluate both the penetration performance and the mechanical strength of medical suture needles. By simulating the actual penetration process during clinical use, the device measures the force applied to the needle tip as it penetrates simulated tissue. At the same time, it performs bending strength tests to assess the durability of the needle under bending conditions. These tests provide essential data to ensure the safety, effectiveness, and reliability of suture needles in surgical procedures.
2. Which application fields can benefit from this tester?
This tester is widely used in quality control for manufacturing enterprises, medical institutions, and medical device research and development. Manufacturers use it to conduct batch sampling tests to detect quality issues such as raw material instability or processing defects, allowing timely production adjustments. Medical institutions rely on the test results to select suture needles that best match surgical requirements, improving patient safety. In R&D, engineers and researchers evaluate different needle materials, structures, and dimensions to optimize design and develop higher-performance suture needles.
3. Which standards does the Suture Needle Penetration and Bending Strength Tester comply with?
The tester is designed and manufactured in accordance with ASTM F3014-2014 and ASTM F1874-98. ASTM F3014-2014 specifies standardized methods for evaluating the penetration performance of surgical suture needles, while ASTM F1874-98 defines procedures for bending strength testing to assess durability under bending stress.
4. What testing items can be measured with this device?
The device supports testing of puncture (penetration) force and bending strength. These two testing items together provide a comprehensive evaluation of a suture needle’s performance during penetration and its resistance to deformation under bending loads.
5. What features ensure accurate and reliable test results?
The tester is equipped with high-precision imported sensors, providing an indication error of ≤0.01 N or 0.1% of full scale. It supports real-time curve display, allowing users to easily identify peaks and valleys in test data. The system also includes over-range pressure shutdown to protect sensors and automatic data storage with power-off memory, ensuring data integrity and measurement reliability.
6. How does the tester support flexible testing and data security?
The system supports multiple testing stations and adjustable test speeds to accommodate different needle specifications, including curved and straight needles. It includes professional testing software with data analysis and reporting functions. For data security, a four-level user password strategy is implemented, and the software complies with GMP computerized system requirements, including user management, permission control, and data audit trails.
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