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yixun
yixunmold
| Attribute | Details |
|---|---|
| Product Name | Custom Medical Plastic Injection Molding Parts / Surgical Components |
| Material Options | Medical Grade PP, PA6 (Nylon), PC, ABS, PEEK, TPU (USP Class VI / ISO 10993 Certified) |
| Mold Steel | S136 / H13 / Stainless Steel (Corrosion Resistant for Cleanroom Production) |
| Cavity Count | 1 to 128 Cavities (High Efficiency for Disposable Items) |
| Tolerance | ±0.01mm - ±0.05mm (High Precision for Medical Fit) |
| Surface Finish | SPI A1 (Mirror), VDI 33, or Custom Texture (Non-slip for Surgical Grip) |
| Certifications | ISO 13485, ISO 9001, FDA Registered Facility, RoHS, REACH |
| Production Environment | 10,000 / 100,000 Class Cleanroom Available |
| Application | Surgical Tools, Diagnostic Devices, Drug Delivery Systems, Hospital Furniture Fixtures |
| Service Type | OEM / Rapid Prototyping / Low Volume to Mass Production |
ISO 13485 Certified: Our quality management system is specifically designed for medical devices.
Biocompatible Materials: We only use resins that pass USP Class VI and ISO 10993 biological evaluation tests.
Traceability: Full material lot tracking from resin supplier to finished part.
Dedicated Class 10,000 (ISO 7) and Class 100,000 (ISO 8) cleanrooms available.
Strict contamination control protocols to ensure parts are free from dust, oil, and particulates.
Automated packaging options (bagging in cleanroom) ready for sterilization (EtO, Gamma, Steam).
High-Precision Molds: Made from corrosion-resistant stainless steel (e.g., S136) to prevent rust and ensure long mold life (>1 million shots).
Tight Tolerances: Capable of holding tolerances down to ±0.01mm, critical for fluid tightness and assembly fit.
Complex Geometries: Expertise in thin-wall molding, micro-molding, and intricate rib/grip structures (as seen in our tapered designs).
PP (Polypropylene): Autoclavable, chemical resistant (Ideal for disposables).
PA6/PA66 (Nylon): High strength, wear resistance (Ideal for structural components).
PC (Polycarbonate): Transparency, impact resistance (Ideal for housings/viewports).
PEEK/Ultem: High temperature, radiolucent (Ideal for implants/surgical tools).
TPE/TPU: Soft touch, flexibility (Ideal for grips/seals).
Diagnostic Equipment: Housings, connectors, and sample holders.
Surgical Instruments: Handles, guards, and locking mechanisms.
Drug Delivery: Syringe components, inhaler parts, pump housings.
Hospital Infrastructure: Specialized fixtures, wall-mount adapters, and equipment supports.
Dental Devices: Handpiece components and disposable tips.
CMM Measurement: 3D coordinate measuring for dimensional accuracy.
Visual Inspection: 100% inspection under controlled lighting (or AOI automated optical inspection).
Material Testing: MFI, Tensile Strength, Impact Resistance testing.
Cleanliness Testing: Particle count verification.
Functional Testing: Assembly fit checks and leak testing (if applicable).
Packaging: Double PE bags, vacuum sealed, placed in clean cartons. Custom labeling with Lot No. and Expiry Date available.
Sterilization Ready: Parts are packaged to facilitate subsequent EtO, Gamma, or Steam sterilization by the customer.
Shipping: Global express (DHL/FedEx/UPS) for samples; Sea/Air freight for mass production.
Yes, we strictly use raw materials with USP Class VI and ISO 10993 certifications. We can provide material certificates (COA) with every shipment.
Absolutely. We have dedicated cleanroom injection molding machines (Class 10k/100k) to ensure zero contamination during production.
Typical lead time is 15-25 days for mold fabrication and 3-5 days for T1 samples. Rush services are available for urgent projects.
Yes, we understand the sensitivity of medical IP. We are happy to sign a mutual NDA before discussing your project details.
![Custom High-Precision Injection Mold for PVC Plastic Surgical Connector Multi-Cavity Tooling OEM Accepted]( "Custom High-Precision Injection Mold for PVC Plastic Surgical Connector Multi-Cavity Tooling OEM Accepted")
