Material Composition | Cardiac surgeries requiring precision | Industry Standard: Metal (general) Our Base: Stainless Steel (ASTM F138) Our Advanced: Surgical-grade Stainless Steel (ASTM F138) + Passivation▲ | Base: Durable and corrosion-resistant(ASTM F138 ensures biocompatibility) Advanced: Enhanced corrosion resistance(Passivation reduces rust) | Advanced: Higher material costs(▲) |
Safety Certification | Hospitals with strict compliance | Industry Standard: ISO 13485 (base) Our Base: ISO 13485 certified Our Advanced: ISO 13485 + ISO 7376 (sterilization)▲ | Base: Meets basic quality standards(ISO 13485) Advanced: Ensures sterilization efficacy(ISO 7376) | Advanced: Requires additional certification costs(▲) |
Shelf Life | Emergency stockpiling | Industry Standard: 2 years (ISO 15889) Our Base: 3 years (ISO 15889) Our Advanced: 5 years (ISO 15889 extended)▲ | Base: Standard storage duration(ISO 15889) Advanced: Longer usability(▲) | Advanced: Requires controlled storage conditions(▲) |
Instrument Classification | Regulatory compliance for global markets | Industry Standard: Class I/II Our Base: Class II (FDA) Our Advanced: Class II + CE Marking▲ | Base: Meets U.S. FDA requirements(Class II) Advanced: EU market access(CE compliance) | Advanced: Higher regulatory scrutiny(▲) |
Ergonomics | Prolonged surgical procedures | Industry Standard: Standard grip Our Base: Ergonomic grip (ISO 9241) Our Advanced: Adjustable ergonomic grip (ISO 9241-411)▲ | Base: Reduces hand fatigue(ISO 9241) Advanced: Customizable fit(▲) | Advanced: Complex design increases cost(▲) |
Reusability | High-volume hospitals | Industry Standard: Single-use Our Base: Reusable (autoclave-safe) Our Advanced: Reusable with 100+ sterilization cycles (AAMI ST79)▲ | Base: Cost-effective over time(reduces waste) Advanced: Extended lifecycle(▲) | Advanced: Requires rigorous sterilization protocols(▲) |