Custom Injection Mold for Medical Equipment Injection Accessory with ISO13485

Core Advantages

1. ISO13485 Full Compliance

   Our mold design, production, and quality control processes strictly adhere to ISO13485 medical device quality management system requirements. From raw material selection to mold testing, every step is documented and traceable, ensuring the molds meet the rigorous safety and performance standards of medical equipment accessories.
2. Medical-Grade Precision & Tolerance Control

   Targeting medical accessories (e.g., syringe components, diagnostic device housings, catheter connectors, respiratory equipment parts), we achieve micron-level mold precision (tolerance ±0.005mm). This ensures consistent dimensional accuracy of injection-molded parts, eliminating assembly errors and guaranteeing compatibility with medical device systems.
3. Medical-Grade Material Compatibility

   The molds are optimized for processing common medical plastics:

• PP/PE: Biocompatible, low-toxicity, suitable for disposable medical accessories.

• PC: High transparency and impact resistance, ideal for medical device observation windows.

• PPSU/PEEK: High-temperature resistant, sterilizable, for reusable surgical instruments and implantable accessory components.

  The mold’s flow channel and cavity design minimize material waste while ensuring uniform plastic filling, avoiding defects like bubbles and warping that affect medical safety.

4. Sterilization Adaptability Design

   Medical equipment accessories require frequent sterilization (autoclaving, ethylene oxide, gamma irradiation). Our molds are engineered to produce parts with stable structures that resist deformation, discoloration, or performance degradation after repeated sterilization cycles—extending the service life of medical devices.
5. High Efficiency for Mass Production

   Equipped with hot runner systems and self-lubricating mold cores, our custom molds enable fast injection cycles (10–30s per cycle) and long mold service life (≥1,000,000 shots). This meets the large-scale production needs of medical device manufacturers while reducing unit production costs.

Quality Assurance System

• Incoming Inspection: All mold steels and components are tested for hardness, corrosion resistance, and purity to avoid contamination of medical parts.

• In-Process Testing: Use 3D coordinate measuring machines (CMM) to inspect cavity dimensions in real time during mold manufacturing.

• Final Validation: Conduct mold trial runs with actual medical-grade materials, and test the produced samples for biocompatibility, dimensional stability, and sterilization resistance before delivery.

Application Scenarios

• Disposable medical consumable accessories (syringe plungers, blood collection tube caps)

• Diagnostic equipment structural parts (test strip holders, sensor housings)

• Surgical instrument components (laparoscopic tool handles, endoscopic accessories)

• In vitro diagnostic (IVD) device parts

Why Choose Us?