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High Precision Plastic Custom Injection Mold for Medical Care Using

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.
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  • YIXUN mold

  • 8480419090

Core Highlights

  • 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.

Technical Specifications

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

Key Advantages for Medical Use

  1. Biocompatibility Assurance: Mold materials and surface treatments avoid material leaching, ensuring compliance with medical device safety requirements.

  2. High Precision for Critical Components: Micro-injection capability for small parts (e.g., syringe nozzles, sensor housings) with tight tolerance control.

  3. Efficient Production: Optimized cooling channels and hot runner systems reduce cycle time, enabling mass production of disposable medical parts.

  4. Durability & Longevity: Heat-treated mold steel (HRC 52-56) resists wear; 1-2 million shot life with proper maintenance.

  5. Sterility Support: Smooth surface finish minimizes microbial adhesion; compatible with autoclave/ethylene oxide (EO) sterilization processes.

Customization Process

  1. Requirement Sharing: Provide 2D/3D drawings (STEP/IGES) of medical components, material specifications, and production volume.

  2. Mold Design & Simulation: FEA analysis for mold flow, cooling, and warpage prediction to optimize design.

  3. Prototype & Testing: Rapid prototype mold for sample validation (dimensional accuracy, material compatibility).

  4. Mold Manufacturing: CNC machining, EDM, wire-cutting, and precision polishing; strict quality inspection (CMM measurement).

  5. Mass Production Support: Mold trial run, process parameter optimization, and after-sales maintenance.

Application Examples

  • 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).

Quality Commitment

  • 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.

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