Material Composition | Medical device packaging, surgical instruments | Industry Standard: Polypropylene (ISO 9001 compliant) Our Base: PET (ISO 13485 compliant) ▲ Our Advanced: PET+ (ISO 13485 + FDA 21 CFR) ▲▲ | ▲ Base: Enhanced chemical resistance (withstands 50+ exposures, ASTM D543) ▲▲ Advanced: FDA traceability for critical devices | Higher cost than PP; requires specialized handling for PET+ |
Sterilization Method | Hospital CSSD sterilization processes | Industry Standard: Steam autoclaving (ASTM F1866) Our Base: Far infrared (30% faster cycle) ▲ Our Advanced: Far infrared + UV (99.9% efficiency) ▲▲ | ▲ Base: Reduces workflow downtime (cycle time: 15 mins vs 22 mins) ▲▲ Advanced: Eliminates residual moisture risks | Requires investment in far infrared/UV equipment |
Certification Compliance | Global medical supply chains | Industry Standard: CE (EN 868-1) Our Base: CE + FDA (510(k)) ▲ Our Advanced: CE + FDA + MDR (EU 2017/745) ▲▲ | ▲ Base: Access to US/EU markets ▲▲ Advanced: Future-proof for EU MDR regulations | Lengthy certification timelines for Advanced tier |
Shelf Life | Long-term storage of medical devices | Industry Standard: 2 years (ISO 11607) Our Base: 3 years (ISO 11607 + ASTM D3985) ▲ Our Advanced: 5 years (accelerated aging tests) ▲▲ | ▲ Base: Reduces inventory turnover costs ▲▲ Advanced: Minimizes replacement frequency for critical devices | Limited long-term performance data beyond 3 years |
Safety Standards | High-risk surgical environments | Industry Standard: Basic CE compliance Our Base: ISO 13485 + ISO 11607 ▲ Our Advanced: ISO 13485 + ISO 11607 + AAMI PB70 ▲▲ | ▲ Base: Meets baseline surgical safety protocols ▲▲ Advanced: Zero-leak integrity (AAMI PB70 leak detection) | Higher production costs for Advanced standards |
Sealing Mechanism | Transporting sharp medical instruments | Industry Standard: Standard flap seal (ASTM F2092) Our Base: Flat tip design (40% less leakage) ▲ Our Advanced: Triple-layer seal + flat tip (99% leak-proof) ▲▲ | ▲ Base: Prevents needlestick injuries during transport ▲▲ Advanced: Military-grade seal integrity (MIL-STD-810G) | Advanced seals require trained personnel for application |