Product Overview
Our Non-Toxic Long-Lasting Small Batch Injection Molding services deliver safe, durable, and precise medical-grade components for healthcare applications. Designed for low-volume production runs, these parts are ideal for medical device startups, pilot production, and specialized equipment requiring biocompatible and non-toxic materials.
With a focus on patient safety, we only use FDA-approved, ISO 10993-tested polymers and manufacture in ISO 13485-certified cleanroom facilities. This ensures every part meets regulatory compliance, maintains dimensional stability, and performs reliably under sterilization and repeated use.
Key Parameters
| Parameter |
Specification |
| Process |
Medical-Grade Plastic Injection Molding |
| Production Volume |
Small batch (50–5,000 units), prototyping to low-volume production |
| Material Options |
Medical-grade PP, PC, PEEK, PEI, PPSU, TPE, ABS |
| Toxicity Compliance |
ISO 10993, FDA-approved, RoHS-compliant |
| Durability |
Designed for long-term use, repeated sterilization cycles |
| Tolerance |
±0.05 mm (standard), ±0.02 mm (high precision) |
| Sterilization Methods |
Autoclave, gamma irradiation, EtO, chemical sterilants |
| Surface Finish |
Smooth, matte, textured, high polish |
| Cleanroom Class |
ISO Class 7 / ISO Class 8 (optional) |
| Certifications |
ISO 13485, ISO 9001, RoHS, FDA-compliant materials |
| Lead Time |
Tooling: 2–3 weeks; Production: 7–10 days |
Selling Points
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Non-Toxic Safety
All materials are biocompatible and FDA-approved for patient-contact applications.
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Small Batch Flexibility
Cost-effective low-volume production for prototypes, trials, or specialty devices.
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Exceptional Longevity
Durable polymers resist wear, impact, and chemical degradation over extended use.
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Regulatory Compliance
Manufactured under ISO 13485-certified processes with full traceability.
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Sterilization Compatibility
Materials withstand autoclave, gamma, EtO, and chemical sterilization without degradation.
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Rapid Prototyping to Production
Smooth transition from design validation to market launch.
Future Trends in Medical Injection Molding
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Greater Demand for Small-Batch Runs due to rapid medical device innovation.
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Non-Toxic Bioplastics for eco-friendly and patient-safe medical products.
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Digital Manufacturing Integration for faster iteration and production scaling.
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Advanced Antimicrobial Materials to reduce infection risks.
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Mass Customization of medical components for patient-specific applications.
Application Scenarios
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Prototype Medical Devices – Early-stage product testing with production-quality materials.
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Specialized Surgical Tools – Low-volume runs for niche medical fields.
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Patient-Specific Equipment – Customized components for individual treatment needs.
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Diagnostic Devices – Precision small-batch parts for lab and point-of-care testing.
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Limited-Edition Healthcare Products – For clinical trials or market evaluation.
Frequently Asked Questions
Q1: What makes your small batch injection molding suitable for medical applications?
A1: We use medical-grade, non-toxic materials and follow strict ISO 13485 protocols to ensure safety and quality.
Q2: Can small batch production still meet regulatory requirements?
A2: Yes. All our production processes meet FDA and ISO standards, regardless of volume.
Q3: What’s the minimum order quantity?
A3: We can produce as few as 50 units for early-stage development.
Q4: How quickly can you deliver prototypes?
A4: Prototypes are typically delivered in 7–10 days after tooling.
Q5: Are these parts compatible with multiple sterilization methods?
A5: Yes. We select materials based on your sterilization requirements, ensuring long-term durability.
Get safe, durable, and precise small batch medical injection molding for your next healthcare innovation — with materials and processes that protect both patients and performance.
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Non-Toxic Long-Lasting Small Batch Injection Molding – Medical Injection Moulding Images
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