医療用針靭性試験器-医療安全精密機器

1. **Product Introduction: Medical Needle Toughness Tester - Precision Instrument for Healthcare Safety**

The Medical Needle Toughness Tester is a specialized device designed to evaluate the mechanical durability of various medical needles including injection needles, blood collection needles, and biopsy needles. This instrument applies controlled bending forces (typically at 0.5Hz frequency) to needle samples with adjustable angles (25° for normal wall, 20° for thin-walled, and 15° for ultra-thin wall needles) while monitoring structural integrity. Key features include high-precision sensors for accurate load measurement (±0.5% accuracy), an intuitive touchscreen interface, and audible alarms that activate when samples fail toughness tests. The tester complies with international medical device standards and provides critical quality control data for manufacturers.

2. **Industry Applications: Ensuring Needle Safety Across Medical Disciplines**

In the medical device industry, needle toughness testing is mandatory for:

- Hypodermic needles: Verifying resistance to bending during injections

- IV cannulas: Testing durability for prolonged vascular access

- Biopsy needles: Ensuring structural stability during tissue sampling

Hospitals use test data to select reliable products, while manufacturers employ these testers for R&D and production QC. Recent advancements allow testing of specialized needles like microwave ablation needles (requiring 30+ bending cycles) and acupuncture needles needing ultra-fine wall assessments. The global market for such testers grew 18% in 2024 due to increased safety regulations.

3. **Step-by-Step Operating Guide for Medical Needle Toughness Testers**

Standard operating procedure:

1. Preparation: Mount the needle sample using the specialized fixture, ensuring 50mm span length

2. Parameter Setup: Select bending angle per needle type (25°/20°/15°) and set to 0.5Hz frequency

3. Test Execution: Initiate 20 bidirectional bending cycles while monitoring real-time force data

4. Result Analysis: Check for:

   - Visual fractures (magnification lens provided)

   - Force deviation >15% from baseline

   - Audible alarm activation

5. Data Export: Save test reports in CSV/PDF format containing:

   - Maximum sustained load (N)

   - Deformation angle at failure

   - Cycle count to failure

Always perform calibration checks using reference needles before critical tests.

4. **Technical Specifications and Measurement Principles**

Core technical parameters:

- Force Range: 0-50N (±0.25N resolution)

- Bending Frequency: 0.1-2Hz programmable

- Angular Accuracy: ±0.5°

- Data Sampling Rate: 1kHz

The tester uses strain gauge technology to measure:

$$ \text{Toughness Index} = \frac{\sum_{i=1}^{20} F_i \cdot \theta_i}{n} $$

Where $F_i$ is bending force at cycle i, $\theta_i$ is angular displacement, and n is total cycles. Advanced models incorporate:

- High-speed cameras (1000fps) for micro-fracture detection

- Temperature-controlled testing (-20°C to 60°C)

- Automated needle feeding systems for high-throughput labs.

5. **Case Study: Improving Biopsy Needle Quality Through Toughness Testing**

A 2024 clinical study with 10,000+ biopsy needles revealed:

- 12% failure rate in standard toughness tests

- Correlation between low toughness scores and procedural complications (p<0.01)

After implementing the tester in production QC:

- Failure rate dropped to 2.3% within 6 months

- Customer complaints reduced by 68%

- Achieved ISO 7864:2016 certification

The hospital reported 40% fewer needle breakage incidents during CT-guided biopsies post-implementation. This case demonstrates how systematic toughness testing enhances patient safety and reduces liability risks.

: Standard Groups. (2024). Medical needle tube toughness tester principle-standard. Retrieved from [Standard Groups website](mailto:info@standard-groups.com)