| Quantity: | |
|---|---|
YIXUN mold
8480419090
Catheter Types: IV catheters, urinary catheters, angiographic catheters, dialysis catheters, neurovascular catheters, and veterinary catheters.
Custom Features: Multi-lumen channels (1-8 lumens), tapered tips, barbed connectors, anti-kink structures, color-coded markers, and laser-etched identification.
Size Flexibility: From micro-catheters (inner diameter ≥ 0.3mm) to large-diameter surgical catheters—molds optimized for thin-walled (wall thickness ≥ 0.15mm) and complex geometries.
Global Regulatory Alignment: Fully compliant with ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 10993 (biocompatibility) standards—ensuring mold-produced catheters meet clinical safety requirements.
Material Compatibility: Specialized for medical-grade plastics:
PP (Polypropylene): Chemical resistance, sterilization compatibility (EO/gamma), cost-effective for disposable catheters.
PE (Polyethylene): Flexibility, low friction, ideal for catheter shafts and balloons.
PC (Polycarbonate): High transparency, impact strength, suitable for catheter hubs and connectors.
PEEK/TPU: High-performance options for 耐磨、耐温 catheter components (on request).
Sterility Support: Smooth, crevice-free cavity surfaces (Ra ≤ 0.01μm) prevent bacterial growth and withstand repeated sterilization without mold degradation.
Micron-Level Tolerance: Dimensional accuracy of ±0.002mm for lumen channels, outer diameters, and sealing surfaces—ensuring consistent fluid flow, leak-proof connections, and compatibility with medical devices (e.g., luer locks).
Complex Geometry Mastery: Advanced 3D modeling (SolidWorks/UG) and flow simulation (Moldflow) optimize mold design for:
Uniform wall thickness (avoiding weak points in catheter shafts).
Smooth transitions between catheter segments (e.g., hub to shaft).
Precision placement of lumens (no cross-contamination risks).
Low Defect Rate: Defect rate < 0.03% via strict process control—critical for catheter reliability in clinical settings.
Premium Mold Materials: Core/cavity constructed with medical-grade S136H stainless steel (hardness HRC 56-60) and vacuum heat treatment—resists corrosion, wear, and maintains precision for 3-5 million cycles.
Efficient Cooling Systems: Custom micro-cooling channels (spiral/linear) with temperature control ±0.5℃—reduces cycle time by 15-25% and prevents warping of thin-walled catheter parts.
Multi-Cavity Options: 2-16 cavity designs (customizable) to meet production needs:
Low-volume (10,000+ parts/month): Ideal for clinical trials or specialty catheters.
High-volume (100,000+ parts/month): Scalable for mass-produced disposable catheters.
Automation Compatibility: Mold design integrated with robotic part removal, vision inspection, and packaging systems—streamlining cleanroom production.
Design Consultation: Our engineering team collaborates with you to review catheter 3D models, material selections, and performance requirements—providing DFM (Design for Manufacturing) recommendations to optimize producibility.
Mold Design & Simulation: 3D mold modeling with flow, cooling, and stress analysis to predict and resolve potential issues (e.g., uneven material flow, warpage).
Precision Machining:
CNC five-axis milling (accuracy ±0.001mm) for complex cavities and lumens.
Wire EDM cutting for micro-features (e.g., thin lumen walls).
Mirror polishing (Ra ≤ 0.01μm) and passivation treatment for biocompatibility.
Cleanroom Assembly & Testing:
Assembly in Class 7 cleanroom to avoid particulate contamination.
Trial injection with target medical-grade materials—verifying dimensional accuracy (CMM inspection), leak tightness (pressure testing), and surface quality.
10,000-cycle validation to ensure mold consistency and durability.
Mass Production Support: On-site technical support for mold installation, process optimization, and compliance documentation (e.g., batch records, material certificates).
| Parameter | Specification |
| Cavity Number | 2/4/8/16 (customizable) |
| Mold Accuracy | ±0.002mm |
| Cycle Time | 12-28 seconds (varies by catheter complexity) |
| Mold Material | Core/Cavity: S136H Stainless Steel; Base: P20 Chrome-Plated Steel |
| Hardness | HRC 56-60 (core/cavity) |
| Cooling System | Micro-spiral/linear cooling channels (±0.5℃ temperature control) |
| Runner System | Hot runner (medical-grade thermal gates) or cold runner |
| Weight | 250-1,200kg (varies by cavity number & catheter size) |
| Compatibility | Medical Injection Machines: 15-80 Ton Clamping Force; Cleanroom Class 8+ |
| Compatible Materials | Medical-grade PP, PE, PC, PEEK, TPU |
| Compliance | ISO 13485, FDA 21 CFR Part 820, EU MDR, ISO 10993, ISO 594-1/2 |
Diagnostic Catheters: Angiographic catheters, electrophysiology catheters, imaging catheter hubs.
Therapeutic Catheters: Dialysis catheters, infusion catheters, balloon catheters (shafts/hubs).
Surgical Catheters: Laparoscopic catheter components, neurovascular catheters, surgical fluid management catheters.
Disposable & Reusable Catheters: Molds optimized for single-use (cost-effective) or multiple-use (durability-focused) designs.
ISO 13485:2016 certified manufacturing facility.
18-month warranty on all mold components (extended for medical applications).
Cleanroom-compatible maintenance kits and sterile replacement parts.
On-site technical support for cleanroom installation, process validation, and regulatory compliance.
Full traceability: Mold components marked with unique serial numbers; batch records provided for audit trails.
Catheter Types: IV catheters, urinary catheters, angiographic catheters, dialysis catheters, neurovascular catheters, and veterinary catheters.
Custom Features: Multi-lumen channels (1-8 lumens), tapered tips, barbed connectors, anti-kink structures, color-coded markers, and laser-etched identification.
Size Flexibility: From micro-catheters (inner diameter ≥ 0.3mm) to large-diameter surgical catheters—molds optimized for thin-walled (wall thickness ≥ 0.15mm) and complex geometries.
Global Regulatory Alignment: Fully compliant with ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 10993 (biocompatibility) standards—ensuring mold-produced catheters meet clinical safety requirements.
Material Compatibility: Specialized for medical-grade plastics:
PP (Polypropylene): Chemical resistance, sterilization compatibility (EO/gamma), cost-effective for disposable catheters.
PE (Polyethylene): Flexibility, low friction, ideal for catheter shafts and balloons.
PC (Polycarbonate): High transparency, impact strength, suitable for catheter hubs and connectors.
PEEK/TPU: High-performance options for 耐磨、耐温 catheter components (on request).
Sterility Support: Smooth, crevice-free cavity surfaces (Ra ≤ 0.01μm) prevent bacterial growth and withstand repeated sterilization without mold degradation.
Micron-Level Tolerance: Dimensional accuracy of ±0.002mm for lumen channels, outer diameters, and sealing surfaces—ensuring consistent fluid flow, leak-proof connections, and compatibility with medical devices (e.g., luer locks).
Complex Geometry Mastery: Advanced 3D modeling (SolidWorks/UG) and flow simulation (Moldflow) optimize mold design for:
Uniform wall thickness (avoiding weak points in catheter shafts).
Smooth transitions between catheter segments (e.g., hub to shaft).
Precision placement of lumens (no cross-contamination risks).
Low Defect Rate: Defect rate < 0.03% via strict process control—critical for catheter reliability in clinical settings.
Premium Mold Materials: Core/cavity constructed with medical-grade S136H stainless steel (hardness HRC 56-60) and vacuum heat treatment—resists corrosion, wear, and maintains precision for 3-5 million cycles.
Efficient Cooling Systems: Custom micro-cooling channels (spiral/linear) with temperature control ±0.5℃—reduces cycle time by 15-25% and prevents warping of thin-walled catheter parts.
Multi-Cavity Options: 2-16 cavity designs (customizable) to meet production needs:
Low-volume (10,000+ parts/month): Ideal for clinical trials or specialty catheters.
High-volume (100,000+ parts/month): Scalable for mass-produced disposable catheters.
Automation Compatibility: Mold design integrated with robotic part removal, vision inspection, and packaging systems—streamlining cleanroom production.
Design Consultation: Our engineering team collaborates with you to review catheter 3D models, material selections, and performance requirements—providing DFM (Design for Manufacturing) recommendations to optimize producibility.
Mold Design & Simulation: 3D mold modeling with flow, cooling, and stress analysis to predict and resolve potential issues (e.g., uneven material flow, warpage).
Precision Machining:
CNC five-axis milling (accuracy ±0.001mm) for complex cavities and lumens.
Wire EDM cutting for micro-features (e.g., thin lumen walls).
Mirror polishing (Ra ≤ 0.01μm) and passivation treatment for biocompatibility.
Cleanroom Assembly & Testing:
Assembly in Class 7 cleanroom to avoid particulate contamination.
Trial injection with target medical-grade materials—verifying dimensional accuracy (CMM inspection), leak tightness (pressure testing), and surface quality.
10,000-cycle validation to ensure mold consistency and durability.
Mass Production Support: On-site technical support for mold installation, process optimization, and compliance documentation (e.g., batch records, material certificates).
| Parameter | Specification |
| Cavity Number | 2/4/8/16 (customizable) |
| Mold Accuracy | ±0.002mm |
| Cycle Time | 12-28 seconds (varies by catheter complexity) |
| Mold Material | Core/Cavity: S136H Stainless Steel; Base: P20 Chrome-Plated Steel |
| Hardness | HRC 56-60 (core/cavity) |
| Cooling System | Micro-spiral/linear cooling channels (±0.5℃ temperature control) |
| Runner System | Hot runner (medical-grade thermal gates) or cold runner |
| Weight | 250-1,200kg (varies by cavity number & catheter size) |
| Compatibility | Medical Injection Machines: 15-80 Ton Clamping Force; Cleanroom Class 8+ |
| Compatible Materials | Medical-grade PP, PE, PC, PEEK, TPU |
| Compliance | ISO 13485, FDA 21 CFR Part 820, EU MDR, ISO 10993, ISO 594-1/2 |
Diagnostic Catheters: Angiographic catheters, electrophysiology catheters, imaging catheter hubs.
Therapeutic Catheters: Dialysis catheters, infusion catheters, balloon catheters (shafts/hubs).
Surgical Catheters: Laparoscopic catheter components, neurovascular catheters, surgical fluid management catheters.
Disposable & Reusable Catheters: Molds optimized for single-use (cost-effective) or multiple-use (durability-focused) designs.
ISO 13485:2016 certified manufacturing facility.
18-month warranty on all mold components (extended for medical applications).
Cleanroom-compatible maintenance kits and sterile replacement parts.
On-site technical support for cleanroom installation, process validation, and regulatory compliance.
Full traceability: Mold components marked with unique serial numbers; batch records provided for audit trails.
