Description:
Our customized plastic injection mold tooling for medical-grade handles is precision-engineered for ergonomic, durable, and sterile component production. Constructed from premium tool steels with mirror-polished cavities, each mold ensures flawless surface finish and tight tolerances. We provide full OEM support, from design validation to high-volume manufacturing, fully compliant with ISO 13485 and FDA requirements.
Features:
| Attribute | Details |
|---|---|
| Place of Origin | Xiamen, China |
| Brand Name | OEM |
| Product Material | Medical-Grade Plastics (PP, ABS, PC, TPE, etc.) |
| Certifications | ISO 13485, ISO 9001, FDA Compliance |
| Cavity Configuration | Fully Custom (Single or Multi-Cavity) |
| Design Options | 2D/3D CAD, Moldflow Analysis |
| Runner System | Hot Runner / Cold Runner |
| Mold Steel Grades | S136, NAK80, 2738, 718H, Stainless Steel |
| Mold Lifespan | 500,000 – 1,000,000+ Shots |
| Surface Finish | SPI A1 Mirror Polish or Custom Texture |
| Lead Time (T1 Sample) | 35–55 Days |
Benefits of Our Tooling:
-
Superior Material Durability & Longevity: Constructed from premium, corrosion-resistant tool steels (S136, NAK80) to withstand high-volume production cycles while maintaining dimensional stability and surface integrity over 1 million shots.
-
Precision-Grade Design for Flawless Parts: CNC-machined cavities with ±0.01mm tolerances and mirror-polished surfaces (SPI A1) ensure smooth, defect-free medical handles with no flash or sink marks, critical for ergonomic and hygienic requirements.
-
Optimized Cycle Time & Energy Efficiency: Conformal cooling channels and advanced hot-runner systems reduce cycle times by 20–30%, enabling cost-effective, high-throughput production while maintaining consistent part quality.
-
Full Regulatory Compliance for Medical Applications: Molds are engineered to meet ISO 13485, FDA 21 CFR, and USP Class VI standards, with integrated venting and cleanroom-compatible designs to prevent contamination and ensure biocompatible finishes.
Production Process:
-
Design & Simulation: Collaborative 3D CAD modeling and Moldflow analysis optimize gate locations, cooling, and material flow to eliminate warpage and ensure uniform wall thickness for ergonomic handle designs.
-
Material Selection & Precision Machining: High-grade steel blocks (S136, NAK80) are CNC-milled, EDM-textured, and mirror-polished to achieve surface finishes down to Ra ≤0.05μm, essential for medical-grade smoothness.
-
Mold Assembly & Calibration: Integration of hot-runner systems, conformal cooling circuits, and ejection mechanisms, calibrated to ±0.01mm accuracy for flawless part release and dimensional consistency.
-
Trial Injection & Validation: Pilot runs using FDA-approved resins (e.g., medical-grade PP, ABS, TPE) verify mold performance, with CMM dimensional checks, surface analysis, and mechanical testing to ensure compliance.
-
Surface Treatment & Certification: Optional nitriding or PVD coating for enhanced wear resistance, followed by full documentation packages including material certifications and ISO 13485 compliance reports.
-
Mass Production Readiness: Final tooling deployed on automated injection molding machines (50–400T) with in-line vision inspection systems for real-time quality monitoring and defect prevention.
Factory Show:
Our advanced manufacturing facility is equipped with state-of-the-art CNC machining centers, mirror EDM, wire EDM, and high-precision grinding systems, ensuring micron-level accuracy in every mold component. We operate 15 rubber compression presses and 2 LSR injection molding machines, complemented by automated assembly and inspection cells. Quality assurance is upheld through rigorous in-process and final inspections using 3D optical projectors, CMMs, durometers, and surface roughness testers, all under ISO 13485 and ISO 9001 certified protocols. Automated systems—including AutoDryers, high-speed doming stations, and precision die-cutters—streamline production, guaranteeing repeatable, high-quality tooling for the most demanding medical applications.