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YIXUN mold
8480419090
Medical-Grade Injection Molds: Precision Tooling for Healthcare Components
Fully compliant with medical industry standards: ISO 13485 (medical device quality management), FDA 21 CFR 177 (food/medical contact materials), and ISO 10993 (biocompatibility).
Material traceability: All mold steels and auxiliary materials come with full certification documentation, supporting your product’s regulatory submission and audit processes.
Sterilization compatibility: Molds are engineered to withstand ethylene oxide (EO) sterilization (up to 60℃/8 hours) and gamma radiation (up to 50 kGy) without degradation.
Mold materials: Use medical-grade stainless steel (316L), corrosion-resistant H13 steel, or NAK80 (mirror-finish steel) for critical surfaces—ensuring no toxic leaching and compatibility with bodily fluids.
Ultra-precise machining: CNC milling, EDM, and CMM (Coordinate Measuring Machine) inspection achieve dimensional accuracy of ±0.005mm, ideal for tight-tolerance parts like infusion valve seals.
Mirror polishing (Ra ≤ 0.01μm): Eliminates surface roughness that could harbor bacteria, meeting the sterile requirements of surgical and invasive medical components.
Complex geometry support: Expertise in molding undercuts, thin walls (down to 0.2mm), and multi-cavity structures (1-16 cavities) for parts like infusion cover lids or catheter connectors.
Heat-resistant configurations: For high-temperature medical plastics (e.g., PEEK, PSU), molds are equipped with temperature-controlled cooling systems to handle processing temperatures up to 350℃.
Contamination control: Mold production occurs in a cleanroom environment (Class 8) to prevent particle contamination—critical for sterile medical devices.
Long mold life: Medical-grade steel molds offer 500,000-1,500,000 cycles, reducing tooling replacement costs for high-volume disposable medical parts.
Reduced post-processing: Precision molding and surface finishing minimize the need for secondary operations (e.g., deburring, sterilization rework), lowering overall production costs.
Fast turnaround: Streamlined DFM (Design for Manufacturability) analysis and dedicated project teams deliver mold lead times of 4-8 weeks (rush orders available for urgent medical device launches).
Design & DFM Analysis: Receive your 3D model (STEP/IGES/STL) → Conduct medical-specific DFM checks (e.g., moldability of sterile surfaces, compatibility with bioplastics) → Finalize mold design with cooling/venting systems optimized for medical use.
Precision Machining: Cleanroom machining (Class 8) → EDM for micro-features → Mirror polishing (Ra ≤ 0.01μm) → CMM inspection to verify dimensional accuracy.
Assembly & Sterile Testing: Assemble mold components with medical-grade lubricants → Conduct test injections using your target bioplastic → Inspect samples for biocompatibility, surface finish, and dimensional stability.
Delivery & Post-Sales Support: Deliver mold with full certification package (material certificates, test reports) → Provide 18-month after-sales service (free maintenance for non-human damage) → Offer on-site technical support for mold installation and production optimization.
Medical-Grade Injection Molds: Precision Tooling for Healthcare Components
Fully compliant with medical industry standards: ISO 13485 (medical device quality management), FDA 21 CFR 177 (food/medical contact materials), and ISO 10993 (biocompatibility).
Material traceability: All mold steels and auxiliary materials come with full certification documentation, supporting your product’s regulatory submission and audit processes.
Sterilization compatibility: Molds are engineered to withstand ethylene oxide (EO) sterilization (up to 60℃/8 hours) and gamma radiation (up to 50 kGy) without degradation.
Mold materials: Use medical-grade stainless steel (316L), corrosion-resistant H13 steel, or NAK80 (mirror-finish steel) for critical surfaces—ensuring no toxic leaching and compatibility with bodily fluids.
Ultra-precise machining: CNC milling, EDM, and CMM (Coordinate Measuring Machine) inspection achieve dimensional accuracy of ±0.005mm, ideal for tight-tolerance parts like infusion valve seals.
Mirror polishing (Ra ≤ 0.01μm): Eliminates surface roughness that could harbor bacteria, meeting the sterile requirements of surgical and invasive medical components.
Complex geometry support: Expertise in molding undercuts, thin walls (down to 0.2mm), and multi-cavity structures (1-16 cavities) for parts like infusion cover lids or catheter connectors.
Heat-resistant configurations: For high-temperature medical plastics (e.g., PEEK, PSU), molds are equipped with temperature-controlled cooling systems to handle processing temperatures up to 350℃.
Contamination control: Mold production occurs in a cleanroom environment (Class 8) to prevent particle contamination—critical for sterile medical devices.
Long mold life: Medical-grade steel molds offer 500,000-1,500,000 cycles, reducing tooling replacement costs for high-volume disposable medical parts.
Reduced post-processing: Precision molding and surface finishing minimize the need for secondary operations (e.g., deburring, sterilization rework), lowering overall production costs.
Fast turnaround: Streamlined DFM (Design for Manufacturability) analysis and dedicated project teams deliver mold lead times of 4-8 weeks (rush orders available for urgent medical device launches).
Design & DFM Analysis: Receive your 3D model (STEP/IGES/STL) → Conduct medical-specific DFM checks (e.g., moldability of sterile surfaces, compatibility with bioplastics) → Finalize mold design with cooling/venting systems optimized for medical use.
Precision Machining: Cleanroom machining (Class 8) → EDM for micro-features → Mirror polishing (Ra ≤ 0.01μm) → CMM inspection to verify dimensional accuracy.
Assembly & Sterile Testing: Assemble mold components with medical-grade lubricants → Conduct test injections using your target bioplastic → Inspect samples for biocompatibility, surface finish, and dimensional stability.
Delivery & Post-Sales Support: Deliver mold with full certification package (material certificates, test reports) → Provide 18-month after-sales service (free maintenance for non-human damage) → Offer on-site technical support for mold installation and production optimization.
