Balloon Dilatation Catheter Tester
The Balloon Dilatation Catheter Tester is designed in accordance with YY 0285.4 and ISO 10555 standards. It is used for testing Rated Burst Pressure (RBP), balloon fatigue, balloon deflation time, and the relationship between balloon diameter and inflation pressure. The system supports multiple test functions in one unit, improving equipment utilization. It is widely used by medical device manufacturers and testing institutions.
Standards
YY 0285.4 Intravascular Catheters – Sterile and Single-Use Catheters – Part 4: Balloon Dilatation Catheters
Appendix A: Rated Burst Pressure (RBP) Test
Appendix B: Balloon Fatigue Test (no leakage or damage during inflation)
Appendix C: Balloon Deflation Time Test
Appendix D: Relationship Between Inflation Diameter and Pressure
YY/T 1704.3-2021
Technical Parameters
Item | Specification |
Measurement Range | 0–5.00 MPa (adjustable) |
Accuracy | ±0.5% |
Resolution | 0.01 MPa |
Data Interface | RS232 (connectable to LIMS system) |
Dimensions | 800 mm × 455 mm × 835 mm (L × W × H) |
Weight | 103 kg |
Environmental Requirements
Item | Specification |
Working Temperature | 10°C–50°C |
Air Supply Pressure | 0.5–0.7 MPa |
Relative Humidity | ≤80% (non-condensing) |
Power Supply | 220 V, 50 Hz |
Technical Features
(1) Large LCD touchscreen displaying the test process with a user-friendly interface
(2) High-precision contact-type balloon diameter measurement device for multi-point measurement in temperature-controlled water
(3) In addition to standard test items, customizable open programs are available to meet specific user requirements
(4) Multiple test modes fully comply with standard requirements
(5) Imported sensor system ensures high accuracy of test results
(6) One-button operation with fully automated pressurization and real-time display
(7) Built-in micro printer for printing complete test information including device number, sample batch, operator, results, and test time
(8) User hierarchical permission management to ensure data integrity and standardization
(9) Customizable authority control for strict operation management
(10) Comprehensive password protection to prevent unauthorized operations and ensure traceability
(11) Encrypted data storage ensuring completeness, safety, and reliability of test records
(12) ISP online upgrade capability for customized services
(13) Local data storage compliant with GMP, with automatic data processing and statistical analysis
(14) Compliant with UDI traceability requirements for the medical industry
Configuration
Main unit, micro printer, test fixtures, constant temperature water bath
FAQ
1. What is this product?
It is a testing instrument used to evaluate performance parameters of balloon dilatation catheters.
2. What is this product used for?
It is used for testing burst pressure, fatigue resistance, deflation time, and pressure–diameter characteristics.
3. What is the working principle of this product?
It measures pressure, deformation, and time data during controlled inflation and deflation of a catheter balloon.
4. Why is this product important?
It ensures the safety, reliability, and compliance of balloon catheters used in medical procedures.
5. What industries is this product suitable for?
It is suitable for medical device manufacturers, testing laboratories, and regulatory inspection institutions.
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