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Mold Maker Injection Mold for Medical Devices PA6 Recycled HIPS Material

DONGGUAN YIXUN INDUSTRIAL CO.,LTD., a leading mold maker with 30+ years of mold expertise, specializes in developing high-performance injection mold for medical parts—catering to the strict safety, precision, and sterility requirements of the medical industry. Backed by ISO13485 certification and a 100,000-level cleanroom, our injection mold solutions ensure every medical part (from endoscope lenses to diagnostic equipment components) meets global medical standards. We integrate advanced manufacturing technology, rigorous quality control, and one-stop service to deliver injection mold that guarantees consistent, reliable production of medical parts for clients worldwide.
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YIXUN Precision Injection Mold: Tailored Solutions for High-Quality Medical Parts

DONGGUAN YIXUN INDUSTRIAL CO.,LTD., a leading mold maker with 30+ years of mold expertise, specializes in developing high-performance injection mold for medical parts—catering to the strict safety, precision, and sterility requirements of the medical industry. Backed by ISO13485 certification and a 100,000-level cleanroom, our injection mold solutions ensure every medical part (from endoscope lenses to diagnostic equipment components) meets global medical standards. We integrate advanced manufacturing technology, rigorous quality control, and one-stop service to deliver injection mold that guarantees consistent, reliable production of medical parts for clients worldwide.

Core Advantages of Our Injection Mold for Medical Parts

  1. Medical-Grade Precision in Injection Mold: Crafted with high-grade LKM mold steel and processed by Charmiles/Sodick mirror EDM (Ra ≤0.02μm) and FANUC CNC machines, our injection mold achieves micron-level tolerance (±0.005mm). This precision is critical for medical parts like microfluidic chips and surgical instrument components, where even minor deviations can impact performance.

  2. Sterility & Compliance-Focused Injection Mold Design: The injection mold’s cavity undergoes anti-corrosion treatment and is compatible with medical-grade materials (liquid silicone, PC, PMMA). This ensures medical parts are free from contamination, meeting ISO13485 and FDA requirements for biocompatibility and sterility.

  3. Efficient Production for Medical Parts: Our injection mold integrates hot runner systems and multi-cavity structures, reducing material waste by 25% and shortening the molding cycle by 20-30%. This efficiency supports large-scale production of high-demand medical parts (e.g., syringe components, medical packaging) without compromising quality.

  4. Customization for Diverse Medical Parts: We design tailored injection mold for various medical parts, including diagnostic device optics, wearable medical sensors, and drug delivery system components. Our team adapts injection mold parameters (temperature control, cooling systems) to match the unique properties of medical-grade materials.

  5. Durability of Injection Mold for Long-Term Use: The injection mold is treated with wear-resistant coatings, ensuring it maintains precision even after 1 million+ cycles of medical parts production. This longevity reduces maintenance costs and ensures consistent output for long-term medical projects.

Production Strength: Powering Reliable Injection Mold & Medical Parts

Advanced Facilities for Medical-Grade Manufacturing

  • Specialized Injection Mold Workshop: Equipped with 50+ precision machines (high-speed CNC, slow wire-cutting, 2.5m gantry milling) dedicated to injection mold production for medical parts. Every machine is calibrated regularly to maintain micron-level accuracy.

  • 100,000-Level Cleanroom: Our ISO13485-certified cleanroom houses 24+ automated injection machines (50T-818T, with robotic arms) for producing medical parts. The controlled environment (temperature: 22±2°C, humidity: 50±5%) prevents dust, particles, and microbes from contaminating medical parts.

  • QA Lab for Medical Parts & Injection Mold: Features 3D CMM (Miracle NC8107), 2D projectors (EV-3020/EV-4030), and biocompatibility testing equipment. We conduct 100% inspection—from injection mold steel hardness testing to final medical parts sterility checks.

Industry Expertise & Global Certifications

  • 30 years of experience in designing injection mold for medical parts, with 90% of mold designers holding 5+ years of medical mold expertise. Our team understands the unique challenges of medical manufacturing (e.g., material compatibility, regulatory compliance).

  • Certified to ISO9001 (quality management), IATF 16949 (automotive, for medical device enclosures), and ISO13485 (medical), ensuring our injection mold and medical parts meet the strictest global standards.

  • Served 50+ countries, providing injection mold and medical parts to leading medical device manufacturers in the US, Europe, Japan, and South America.

One-Stop Service for Medical Parts Production

We streamline the process from injection mold design to medical parts delivery:
  1. Pre-Production Consultation: Receive client medical parts drawings/specifications → Conduct DFM (Design for Manufacturability) analysis for injection mold → Provide 3D prototypes of medical parts.

  2. Injection Mold Development: Design injection mold (3+ review rounds to address medical compliance) → Manufacture and assemble the mold → Conduct trial tests with medical-grade materials → Verify medical parts samples.

  3. Mass Production & Delivery: Produce medical parts in the cleanroom → Conduct sterility and performance testing → Package medical parts in tamper-proof, sterile packaging → Ship with full compliance documentation.

Key Technical Specifications

Parameter Injection Mold for Medical Parts Medical Parts Details
Material LKM mold steel (S136, STAVAX), DME components Liquid silicone, medical PC, PMMA, PEEK
Dimensional Tolerance ±0.005mm ±0.01mm (critical components)
Surface Roughness Ra ≤0.02μm (cavity) Ra ≤0.02μm (contact surfaces)
Operating Temperature -40°C to 180°C -40°C to 120°C (most medical parts)
Molding Cycle 20-80 seconds (depends on part size) N/A
Certification ISO13485, ISO9001, IATF 16949 ISO13485, FDA (where applicable)
Maximum Part Size Up to 2.5m (via 2.5m gantry milling) Up to 2.5m (e.g., large medical device enclosures)

FAQ

Q1: Can your injection mold produce small, complex medical parts (e.g., micro-needles, microfluidic channels)?

A1: Yes. Our injection mold uses micro-machining technology (with precision up to 0.001mm) to create intricate features for small medical parts. We also optimize the injection mold’s gating and cooling systems to avoid defects in micro-scale medical components.

Q2: How do you ensure the injection mold doesn’t contaminate medical parts?

A2: We use medical-grade mold materials (e.g., corrosion-resistant S136 steel) and conduct regular mold cleaning and disinfection. The injection mold is also tested for leachables and extractables to ensure no harmful substances transfer to medical parts—meeting ISO13485 requirements.

Q3: What is the lead time for a custom injection mold and medical parts samples?

A3: The lead time for a custom injection mold is 35-45 days (depending on complexity). Medical parts samples are ready in 7-15 days after injection mold trial testing. Mass production lead time is 30-60 days, with faster turnaround for urgent medical projects.

Q4: Do you provide after-sales support for injection mold used in medical parts production?

A4: Yes. We offer a 1-year warranty for injection mold, including free maintenance and repairs. Our team provides 24/7 technical support—if the injection mold has issues during medical parts production, we send engineers for on-site troubleshooting or repair the mold in our workshop.

Partner with YIXUN for Medical-Grade Injection Mold & Parts

At YIXUN, we understand that medical parts demand uncompromising precision, safety, and compliance—and our injection mold solutions are engineered to deliver exactly that. With 30 years of expertise, ISO13485 certification, and a customer-centric approach, we’re committed to helping medical device manufacturers create reliable, high-quality products. Whether you need a custom injection mold for a new medical part or large-scale production support, we’re your trusted partner.

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Yixun is the China first generation mold maker, specialize in mold and moulding, provide one-stop plastic manufacturing service, feature in building medical and healthcare device tooling.
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