Material Composition | Surgical procedures requiring durability | - Industry Standard: Stainless Steel (ASTM A240) - Our Base: Stainless Steel (ASTM A240) - Our Advanced: Stainless Steel + passivation treatment (ASTM A967) ▲ | Enhanced corrosion resistance in Advanced (retains sharpness longer) | Base version may require more frequent sharpening; Advanced has higher cost. |
Safety Compliance | Sterile surgical environments | - Industry Standard: ISO 13485 certification - Our Base: GB2626-2006 (respirator standard) - Our Advanced: ISO 13485 + GB2626 ▲▲ | Advanced meets global medical standards (ISO 13485) | Base may not qualify for international markets lacking GB2626 recognition. |
Shelf Life | Storage in medical facilities | - Industry Standard: 1 year (ISO 11137) - Our Base: 1 year (ISO 11137) - Our Advanced: 3 years (ISO 11137 + advanced packaging) ▲▲ | Advanced reduces replacement frequency by 66% | Base requires more frequent inventory checks. |
Reusability | Multiple surgical uses | - Industry Standard: 50+ uses (ISO 17602) - Our Base: 50 uses (ISO 17602) - Our Advanced: 100+ uses (ISO 17602 + enhanced sterilization) ▲ | Advanced cuts costs by halving replacement needs | Base may degrade faster under repeated sterilization cycles. |
Application Scope | Complex surgical tasks | - Industry Standard: General surgery - Our Base: General surgery ▲ - Our Advanced: General + laparoscopic procedures ▲▲ | Advanced handles delicate tasks like cholangiography | Base limited to standard procedures; Advanced requires specialized training. |
Regulatory Classification | Compliance with global regulations | - Industry Standard: Class I (FDA/CE) - Our Base: Class I ▲ - Our Advanced: Class I + additional certifications (e.g., CE Annex IX) ▲▲ | Advanced qualifies for stricter regulatory regions (e.g., EU/US) | Base may face restrictions in markets requiring advanced certifications. |