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YIXUN mold
8480419090
Medical-Grade Compliance: Meets ISO 13485 standards; compatible with biocompatible materials (PP, PE, ABS, PC, medical-grade PVC).
Precision Engineering: Dimensional tolerance ±0.005mm, surface finish Ra≤0.1μm (mirror polish), repeatability ±0.002mm.
Customization Capability: Tailored to medical device components (syringe parts, diagnostic tool housings, surgical instrument accessories).
Reliability & Sterility: Corrosion-resistant mold steel (S136, H13), mold cooling system optimized for consistent production; easy-to-sterilize design.
| Parameter | Details |
|---|---|
| Mold Material | Medical-grade S136/H13 steel (core/cavity); P20 steel (base plate) |
| Dimensional Tolerance | ±0.005mm (critical features) |
| Surface Finish | Mirror polish (Ra≤0.1μm), electrolytic polishing option |
| Cavity Number | 1-32 cavities (based on component size) |
| Cycle Time | 10-30 seconds (varies by part complexity) |
| Compatibility | Biocompatible plastics (PP, PE, ABS, PC, PVC, TPE) |
| Certification | ISO 13485, FDA 21 CFR Part 820 |
Biocompatibility Assurance: Mold materials and surface treatments avoid material leaching, ensuring compliance with medical device safety requirements.
High Precision for Critical Components: Micro-injection capability for small parts (e.g., syringe nozzles, sensor housings) with tight tolerance control.
Efficient Production: Optimized cooling channels and hot runner systems reduce cycle time, enabling mass production of disposable medical parts.
Durability & Longevity: Heat-treated mold steel (HRC 52-56) resists wear; 1-2 million shot life with proper maintenance.
Sterility Support: Smooth surface finish minimizes microbial adhesion; compatible with autoclave/ethylene oxide (EO) sterilization processes.
Requirement Sharing: Provide 2D/3D drawings (STEP/IGES) of medical components, material specifications, and production volume.
Mold Design & Simulation: FEA analysis for mold flow, cooling, and warpage prediction to optimize design.
Prototype & Testing: Rapid prototype mold for sample validation (dimensional accuracy, material compatibility).
Mold Manufacturing: CNC machining, EDM, wire-cutting, and precision polishing; strict quality inspection (CMM measurement).
Mass Production Support: Mold trial run, process parameter optimization, and after-sales maintenance.
Disposable medical supplies: Syringe barrels, infusion set components, respiratory mask parts.
Diagnostic equipment: Sensor housings, test tube holders, analyzer components.
Surgical instruments: Handle casings, instrument accessories, implantable component molds (with biocompatible material compatibility).
100% dimensional inspection before delivery (CMM, optical measuring instrument).
Compliance with medical device regulations (ISO 13485, FDA); material certification provided.
12-month warranty for mold quality; 24/7 technical support for production issues.

Medical-Grade Compliance: Meets ISO 13485 standards; compatible with biocompatible materials (PP, PE, ABS, PC, medical-grade PVC).
Precision Engineering: Dimensional tolerance ±0.005mm, surface finish Ra≤0.1μm (mirror polish), repeatability ±0.002mm.
Customization Capability: Tailored to medical device components (syringe parts, diagnostic tool housings, surgical instrument accessories).
Reliability & Sterility: Corrosion-resistant mold steel (S136, H13), mold cooling system optimized for consistent production; easy-to-sterilize design.
| Parameter | Details |
|---|---|
| Mold Material | Medical-grade S136/H13 steel (core/cavity); P20 steel (base plate) |
| Dimensional Tolerance | ±0.005mm (critical features) |
| Surface Finish | Mirror polish (Ra≤0.1μm), electrolytic polishing option |
| Cavity Number | 1-32 cavities (based on component size) |
| Cycle Time | 10-30 seconds (varies by part complexity) |
| Compatibility | Biocompatible plastics (PP, PE, ABS, PC, PVC, TPE) |
| Certification | ISO 13485, FDA 21 CFR Part 820 |
Biocompatibility Assurance: Mold materials and surface treatments avoid material leaching, ensuring compliance with medical device safety requirements.
High Precision for Critical Components: Micro-injection capability for small parts (e.g., syringe nozzles, sensor housings) with tight tolerance control.
Efficient Production: Optimized cooling channels and hot runner systems reduce cycle time, enabling mass production of disposable medical parts.
Durability & Longevity: Heat-treated mold steel (HRC 52-56) resists wear; 1-2 million shot life with proper maintenance.
Sterility Support: Smooth surface finish minimizes microbial adhesion; compatible with autoclave/ethylene oxide (EO) sterilization processes.
Requirement Sharing: Provide 2D/3D drawings (STEP/IGES) of medical components, material specifications, and production volume.
Mold Design & Simulation: FEA analysis for mold flow, cooling, and warpage prediction to optimize design.
Prototype & Testing: Rapid prototype mold for sample validation (dimensional accuracy, material compatibility).
Mold Manufacturing: CNC machining, EDM, wire-cutting, and precision polishing; strict quality inspection (CMM measurement).
Mass Production Support: Mold trial run, process parameter optimization, and after-sales maintenance.
Disposable medical supplies: Syringe barrels, infusion set components, respiratory mask parts.
Diagnostic equipment: Sensor housings, test tube holders, analyzer components.
Surgical instruments: Handle casings, instrument accessories, implantable component molds (with biocompatible material compatibility).
100% dimensional inspection before delivery (CMM, optical measuring instrument).
Compliance with medical device regulations (ISO 13485, FDA); material certification provided.
12-month warranty for mold quality; 24/7 technical support for production issues.
