Guidewires Tip Flexibility Tester | ISO 11070, FDA Guidance (16007)
Guidewires Tip Flexibility Tester – ToronMed™ GTFT01 is a specialized instrument designed to evaluate the tip flexibility of intravascular guidewires and catheters. With its advanced displacement measurement system, high-precision load cell, and real-time data processing, this tester provides accurate and repeatable results for R&D laboratories, medical device manufacturers, and regulatory compliance testing.
Standards Compliance
The ToronMed™ GTFT01 Guidewires Tip Flexibility Tester is designed in accordance with:
- ISO 11070 – Intravascular catheters – Sterile and single-use intravascular catheters
- FDA Guidance (16007) – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
Standard Configuration
- Main instrument unit
- 10.1-inch touchscreen interface
- Transparent test base (2 pcs)
- Measuring block
- Micro printer
- Test fixture
Why Choose Guidewires Tip Flexibility Tester – ToronMed™ GTFT01?
The Guidewires Tip Flexibility Tester – ToronMed™ GTFT01 ensures precision, compliance, and reliability for evaluating guidewire and catheter tip flexibility. With its large touchscreen interface, automated calibration, transparent observation base, and GMP-ready data management, it is the ideal solution for medical device manufacturers, inspection authorities, and R&D centers. By ensuring flexibility standards are met, this tester helps guarantee safety, durability, and clinical performance of interventional devices.
- Basic Applications
- Intravascular guidewires
- Extended Applications
- Thin catheters
- Other interventional devices requiring tip flexibility testing
- High Accuracy & Repeatability
Imported load cell ensures 0.5% FS accuracy, with stable performance and long service life. - Advanced Displacement Control
Accuracy up to 0.1 mm, with stepless adjustment and precise control over the testing process. - 10.1-Inch Color Touchscreen
Intuitive interface with real-time curve display and data analysis. - Transparent Test Base
Professionally designed base allows clear observation of guidewire behavior during testing. - Data Management
Stores 100,000+ test records, with micro printer and USB interface for convenient data transfer and reporting. - User-Defined Testing
Adjustable curve points for customized test profiles and flexible research applications. - Automated Calibration & Judgment
Simplifies operation while ensuring reliable performance. - Data Security (Optional)
GMP-compliant software with user management, authority levels, and audit trail capabilities. - Safety Protection
Over-range shutdown automatically prevents sensor overload.
Test Principle
The Guidewires Tip Flexibility Tester applies controlled force to the tip of a guidewire or catheter, measuring its displacement and resistance. This simulates clinical conditions to evaluate flexibility, durability, and overall product safety. Results are recorded, analyzed, and stored automatically.
Specification | Value |
|---|---|
| Test Range | 0–500 g |
| Accuracy | 0.5% FS |
| Resolution | 0.001 g |
| Displacement Range | 0.001–40.000 mm |
| Displacement Resolution | 0.001 mm |
| Test Speed | 0–10 mm/s |
| Speed Accuracy | ±0.01 mm/s |
| Dimensions | 500 × 400 × 350 mm |
| Net Weight | 21 kg |
| Voltage | AC 220V 50Hz (110V is also available) |