What Is Medical Injection Molding?
Medical injection molding is a specialized plastic manufacturing process used to produce high-precision components for the healthcare and medical device industries. Unlike general injection molding, this process involves strict adherence to regulatory standards, high cleanliness levels (including cleanroom production), and the use of medical-grade plastic materials such as PEEK, PC, pp, and TPE.
This technology supports the mass production of complex medical plastic parts with extremely tight tolerances, biocompatibility, and consistency—making it essential for disposable medical products and diagnostic equipment.
Advantages of Medical Grade Injection Molding
The benefits of using medical grade injection molding go beyond efficiency. Here’s what makes it indispensable for healthcare:
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High Precision & Repeatability: Critical for surgical and diagnostic components
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Material Safety: Use of FDA-approved and ISO 10993 tested materials
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Cleanroom Compatibility: Minimizes contamination risks during production
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Cost-Effective at Scale: Ideal for both high-volume and mid-volume medical production
Long-tail keywords included:
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medical grade plastic injection molding
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ISO 13485 certified injection molding
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Applications of Medical Injection Molding in the Healthcare Industry
Medical plastic injection molding is applied across a broad range of healthcare and pharmaceutical applications, such as:
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Surgical Instruments
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IV and Infusion Set Components
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Diagnostic Testing Equipment
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Inhalers and Respiratory Devices
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Implantable Plastic Housings
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Catheters, Valves, and Connectors
🔗 Related page: Medical Device Molding Services
Materials Used in Medical Plastic Injection Molding
Choosing the right material is essential for medical compliance, biocompatibility, and performance. At XLD Mould, we work with:
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ポリカーボネート (PC): Impact-resistant, used in diagnostic equipment
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ポリプロピレン (pp): Sterilizable and chemically resistant
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ピーク: Suitable for implantable devices
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TPE & TPU: Flexible and skin-safe
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液状シリコーンゴム (LSR): For microfluidics and neonatal care products
These medical-grade polymers meet the required safety and regulatory standards for clinical and surgical use.
Why Choose XLD Mould for Medical Injection Molding?
XLD Mould brings over 25 years of experience in precision injection molding, with a specialized focus on medical device components. We offer full support from design and mold making to final packaging and logistics.
Our capabilities include:
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260+ injection machines from global brands like Fanuc, Toshiba, Sumitomo, Nissei, Haitian
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Mold class options for long-term production
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Multi-shot and overmolding for medical handles and soft-touch parts
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In-house tooling and ISO Class 8 cleanroom options
🔗 Explore more: Injection Molding Capabilities
🔗 Learn more about our 会社 & Certifications
Medical Injection Molding Process at a Glance
To ensure the best results for your medical components, we follow a systematic process:
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Design & Engineering Consultation
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Precision Mold Tooling
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材料の選択 (Medical Grade Only)
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Cleanroom Injection Molding Production
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In-Line Quality Inspection and Testing
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Assembly, パッケージング, and Sterilization (Optional)
🔗 See how we build our Injection Molds
Certifications & Compliance
To ensure our clients meet market and regulatory demands, we strictly follow:
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ISO 13485: Medical Device Quality Management System
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FDA 21 CFR Part 820 compliance (as required by customers)
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GMP and Cleanroom Production Standards (ISOクラス 8)
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ROHS & REACH Compliance for Materials
Every batch is tested with traceability and full documentation available.
Get a Quote for Custom Medical Plastic Parts
Are you a medical device startup, OEM, or contract manufacturer looking for a reliable partner? Whether you need high-volume medical component molding or small-batch prototyping for clinical testing, XLD Mould is here to help.
📩 Contact us for a free consultation on your next project.
🔗 Request a Quote
結論
Medical injection molding is the backbone of many innovative healthcare solutions. With the right partner, like XLD Mould, you can ensure precision, compliance, and scalable production for your medical devices.
From mold design to cleanroom molding, we are committed to delivering quality at every step.