Medical Applications

Medical injection molding requires strict adherence to regulatory standards, clean room environments, and validated processes. This guide covers key requirements for medical device manufacturing.

Common Medical Applications

• Diagnostic devices: Test strip housings, diagnostic cartridges, lab consumables
• Drug delivery: Syringe barrels and plungers, insulin pens, inhaler components
• Surgical instruments: Handle assemblies, trocars, clip appliers
• Implantable devices: Orthopedic components, surgical mesh insertion tools
• Hospital equipment: IV connectors, respiratory masks, filtration housings

Regulatory Requirements

• ISO 13485: Quality management system for medical devices
• ISO 14644: Clean room classification (typically Class 7 or 8 for molding)
• FDA 21 CFR Part 820: US Quality System Regulation
• USP Class VI: Biocompatibility testing for implantable materials
• EU MDR: Medical Device Regulation for European market access

Material Selection

Common medical-grade materials include: PC/ABS (device housings), PP (syringes, containers), PE (tubing connectors), PEEK (implants, high-temp applications), and POM (surgical instrument handles).