Material Quality | High-precision surgeries (e.g., orthopedics) | Industry Standard: Stainless Steel (ASTM A240) Our Base: 304 Stainless Steel (ASTM A240) Our Advanced: 316L Stainless Steel (ASTM F138)▲ | ▲ Advanced: 50% higher corrosion resistance (ISO 9090) for prolonged use in saline environments | Base version may require frequent sterilization checks in harsh conditions |
Reusability | Hospitals with high surgical volume | Industry Standard: Single-use disposable tools (ISO 15223) Our Base/Advanced: Reusable (≥500 sterilization cycles per ISO 17665)▲ | Reduces waste by 90% vs single-use tools; cost-effective for frequent use | Requires dedicated sterilization protocols (▲ Advanced: Faster sterilization compatibility) |
Certifications | EU-regulated medical facilities | Industry Standard: Basic CE marking Our Base: EPR France/Germany Packing▲ Our Advanced: EPR + RoHS (EU Directive 2011/65/EU)▲▲ | ▲▲ Advanced meets stricter EU chemical compliance for export flexibility | Base lacks RoHS, limiting use in certain EU markets |
Instrument Classification | Complex surgical procedures | Industry Standard: Class I (non-invasive) Our Base/Advanced: Class II (invasive, ISO 13485)▲ | ▲ Ensures compatibility with regulated surgical workflows (e.g., bone drilling) | Higher regulatory scrutiny during procurement |
Safety Standards | High-risk surgical environments | Industry Standard: Basic electrical safety (IEC 60601-1) Our Base: MFDS-compliant (Korea)▲ Our Advanced: IEC 60601-1 + IPX7 waterproof▲▲ | ▲▲ Advanced prevents electrical faults in fluid-heavy surgeries | Base may require additional waterproofing kits for wet environments |
Shelf Life | Long-term inventory storage | Industry Standard: 6 months (ISO 11137) Our Base: 12 months▲ Our Advanced: 24 months (accelerated aging test ASTM E2022)▲▲ | ▲▲ Advanced reduces stock rotation costs by 50% | Base requires more frequent inventory checks |