Considerations for Medical Device Injection Mold Manufacturing
Medical device injection mold manufacturing is a specialized process with more stringent requirements and higher precision standards compared to general mold manufacturing. This is due to the critical role medical devices play in patient health and safety. Here are some key considerations for medical device injection mold manufacturing:
Material Selection:
The materials used in medical device molds must adhere to strict biocompatibility, non-toxicity, and corrosion resistance standards for medical device materials. These materials undergo rigorous testing and certification. Common materials for medical device injection molds include:
Polycarbonate (PC): With excellent transparency, impact resistance, and high-temperature tolerance, PC is widely used for surgical instruments, disposable medical supplies, and other applications.
Polypropylene (PP): Known for its abrasion resistance and chemical resistance, PP is commonly used in syringes, IV tubing, and other medical components.
Polyethylene (PE): Exhibiting good biocompatibility and flexibility, PE is often used for catheters, artificial joints, and other medical devices.
ABS Resin: Offering a combination of desirable properties, ABS resin is frequently employed for medical device housings and enclosures.
Mold Design:
Medical device mold design must carefully consider product requirements, it should minimize defects like flashes and burrs.
Mold Manufacturing:
Medical device mold manufacturing must strictly adhere to medical device quality management system requirements. It should utilize high-precision machining equipment and involve experienced operators.
Mold Inspection:
The inspection process encompasses visual examination, dimensional inspection, geometric accuracy inspection, functional testing, and other relevant checks.
Production Management:
Medical device mold production strictly adheres to medical device production quality management norms. It establishes a comprehensive production record and traceability system. The production environment must maintain cleanliness and, if necessary, employ aseptic injection molding techniques within a cleanroom.
