Glossary Term
Injection Molding
Definition
Injection molding is a manufacturing process used to produce parts by injecting molten material, typically plastics, metals, or ceramics, into a pre-designed mold. The process is widely used in the MedTech industry to create precise, repeatable, and scalable components for medical devices.
Relevance to the MedTech Industry
Injection molding enables the mass production of medical device components with consistent quality, tight tolerances, and complex geometries. It is essential for cost-effective production of single-use devices, reusable components, and critical device enclosures while meeting stringent regulatory and quality standards.
Additional Information & Related Terms
Key Components of Injection Molding
Mold Design
Requires precision engineering to create molds that define the shape, dimensions, and surface finish of components.
Material Selection
Uses biocompatible materials, such as medical-grade plastics (e.g., polycarbonate, PEEK), to ensure safety and compliance.
Process Parameters
Includes temperature, pressure, and injection speed, which are tightly controlled to achieve consistent results.
Post-Processing
Includes trimming, cleaning, and sometimes sterilizing molded components to prepare them for use.
Related Terms
Biocompatibility (ISO 10993): Ensures materials used in injection molding are safe for medical applications.
Cleanroom Manufacturing: Critical for producing sterile injection-molded components.
Prototyping: Injection molding is often used after initial prototypes created with other methods like 3D printing.
Sterilization Validation (ISO 11137): Ensures molded components meet sterilization requirements for medical devices.