Material Composition | Wound care, surgical prep | Industry Standard: 90% silicone (ISO 527: 3.8 MPa tensile strength) Our Base: 100% medical-grade silicone (ISO 527: 5.2 MPa▲) Our Advanced: Reinforced silicone blend (ISO 527: 6.5 MPa▲▲) | Base/Advanced: Superior adhesion for irregular wound contours Advanced: 70% stronger tear resistance▲▲ | Industry Standard: Prone to peeling under stress Advanced: Higher cost▲▲ |
Softness | Sensitive skin applications | Industry Standard: 18 N/cm² softness (ISO 13934-1) Our Base: 12 N/cm²▲ Our Advanced: 8 N/cm²▲▲ (ISO 13934-1) | Base/Advanced: Reduced irritation for chronic wounds Advanced: 57% softer▲▲ | Base: Shorter shelf life vs. Standard Advanced: Requires careful handling▲▲ |
Temperature Resistance | High-heat sterilization | Industry Standard: Up to 150°C (ASTM E135) Our Base: 180°C▲ Our Advanced: 220°C▲▲ (ASTM E135) | Base/Advanced: Safe for autoclave sterilization Advanced: Withstands extreme surgical environments▲▲ | Industry Standard: Limited to low-heat sterilization Advanced: Less flexible▲▲ |
Disinfecting Compatibility | Ozone-based sterilization | Industry Standard: Ozone resistance: 24hr exposure (ASTM E2910) Our Base: 48hr▲ Our Advanced: 72hr▲▲ (ASTM E2910) | Base/Advanced: Maintains integrity after repeated sterilization Advanced: 3x longer ozone resistance▲▲ | Industry Standard: Degradation after 3 cycles Advanced: Higher material cost▲▲ |
Shelf Life | Long-term inventory storage | Industry Standard: 2 years Our Base: 3 years▲ Our Advanced: 4 years▲▲ (ISO 11607) | Base: Meets FDA/EU requirements Advanced: 50% longer storage▲▲ | Industry Standard: Risk of adhesive失效 after 18 months Advanced: Requires controlled storage▲▲ |
Certification Compliance | Global medical markets | Industry Standard: FDA 510(k) only Our Base: FDA 21 CFR 880.6250 + MDR (EU)▲ Our Advanced: FDA + MDR + EPR Germany/France▲▲ | Base: Access to EU/US markets Advanced: Full EPR compliance for sustainability▲▲ | Industry Standard: Limited regional approval Advanced: Complex certification process▲▲ |