Core Advantages: Medical-grade Silicone × Dual-Lumen Fluid Dynamics × Visual Operation Support
| Feature |
Technical Specifications
|
| Dual-Channel System | ① Inflation Lumen: Spherical balloon with precision pressure control, anti-collapse
|
| Medical Silicone Tubing | ISO 10993 biocompatibility certified:
|
| 360° Symmetrical Balloon | Radial expansion deviation <5%,burst pressure ≥6ATM (Complies with YY 0325) |
· Visualization System:
o Embedded barium sulfate line (X-ray visible length ≥35cm)
o Biomarker scale (5mm graduations, ±0.3mm tolerance)
· Kink-Resistant Tubing:
o Flexural strength ≥150N (ASTM D790)
o Chemical resistance: Compatible with glutaraldehyde/peracetic acid disinfectants
· Sterility Assurance:
o EO sterilization (residue ≤0.1ppm)
o Dual sterile barrier packaging (ISO 11607)
| Size (Fr) | Outer Ø (mm) | Lumen Area (mm²) | Balloon Vol (ml) | Max Flow (ml/min) | Connector Type |
| 8Fr | Ø2.67 | 3.5 | 3-5 | 35 | Standard Luer lock |
| 12Fr | Ø4.00 | 8.4 | 5-10 | 85 | Anti-reflux valve |
| 16Fr | Ø5.33 | 14.1 | 5-15/30 | 150 | Rotary diverter |
| 20Fr | Ø6.67 | 22.1 | 5-15/30 | 240 | Suction port |
| 26Fr | Ø8.67 | 37.9 | 5-15/30 | 400 | Irrigation 3-way |
| Test Item | Standard Value | Compliance Standard |
| Balloon Fatigue Resistance | >5,000 inflation/deflation cycles | ISO 20695 |
| Tensile Strength | ≥15N/mm² | GB/T 1040.3 |
| Short-term Biofilm Formation | <10² CFU/cm² (72hrs) | ASTM E2180 |
| Acute Hemolysis Rate | ≤0.8% (vs. 5% threshold) | ISO 10993-4 |




