ISO13485 Secure Leak-Proof Connection Mould 1*8 Transparent PP Medical T Valve Connector Mold
This is a high-precision 1×8 cavity injection mold designed for manufacturing transparent polypropylene (PP) medical T-valve connectors, engineered to meet ISO 13485 medical device quality management standards. The mold produces leak-proof, burr-free, and dimensionally consistent 3-way T connectors, ideal for use in medical tubing systems, oxygen delivery setups, and fluid transfer applications. With an 8-cavity configuration, it balances high-volume production efficiency with strict medical-grade quality control, ensuring every connector meets regulatory and functional requirements.
This is a high-precision 1×8 cavity injection mold designed for manufacturing transparent polypropylene (PP) medical T-valve connectors, engineered to meet ISO 13485 medical device quality management standards. The mold produces leak-proof, burr-free, and dimensionally consistent 3-way T connectors, ideal for use in medical tubing systems, oxygen delivery setups, and fluid transfer applications. With an 8-cavity configuration, it balances high-volume production efficiency with strict medical-grade quality control, ensuring every connector meets regulatory and functional requirements.
2. Key Features
✅ ISO 13485 Certified Compliance: Built and validated under ISO 13485 standards, with full traceability and process validation to meet medical device manufacturing requirements.✅ 1×8 Cavity High-Efficiency Design: Simultaneously molds 8 parts per cycle, maximizing output while maintaining tight tolerances for medical applications.✅ Medical-Grade PP Compatibility: Optimized for transparent polypropylene, ensuring biocompatibility, chemical resistance, and clarity for visual fluid monitoring.✅ Leak-Proof Connection Geometry: Precision-engineered sealing surfaces and dimensional accuracy ensure airtight, leak-free connections in medical tubing systems.✅ Smooth, Burr-Free Finishing: Polished mold cavities eliminate sharp edges, flash, and contaminants, meeting cleanroom production requirements for medical devices.✅ Durable Mold Construction: Corrosion-resistant, high-hardness mold steel ensures long service life (≥500,000 cycles) with consistent performance over mass production.✅ Easy Ejection & Assembly: Optimized ejection mechanism prevents part damage, ensuring clean, defect-free removal suitable for sterile medical environments.
3. Mold & Product Specifications
Parameter
Details
Mold Type
1×8 Cavity Injection Mold
Application
Medical T Valve Connector (3-Way Tubing Adapter)
Material Compatibility
Medical-Grade Polypropylene (PP)
Certification Standard
ISO 13485
Tolerance
±0.01 mm (precision critical dimensions)
Runner System
Cold Runner (or optional hot runner for clean production)
Ejection System
Pin Ejection (customizable for delicate parts)
Surface Finish
High Polish (Ra ≤ 0.2 μm) for transparency and hygiene
Mold Steel
H13 / 2344 (heat-treated for wear resistance)
Cycle Time
Optimized for high-volume medical production
4. Applications of the Molded T Connectors
The connectors produced by this mold are widely used in medical and life sciences applications, including:
Oxygen therapy and respiratory circuits
IV infusion and fluid transfer systems
Laboratory tubing assemblies
Suction and drainage devices
Disposable medical tubing adapters requiring leak-proof, sterile connections
5. Why Choose This Mold?
Regulatory Confidence: ISO 13485 compliance ensures your production meets global medical device quality standards, reducing market entry risks.
Cost Efficiency: 8-cavity design lowers per-unit production costs without compromising quality, making it ideal for mass-market disposable medical components.
Quality Consistency: Precision tooling and validated processes ensure every connector maintains uniform dimensions, sealing performance, and clarity.
Medical-Grade Safety: The mold is designed for cleanroom-compatible production, minimizing contamination risks and supporting sterile manufacturing workflows.
Long-Term Reliability: High-quality mold steel and precision engineering deliver extended tool life, reducing downtime and replacement costs.
6. FAQ
Q: Is this mold suitable for cleanroom medical production?A: Yes, the mold is designed for cleanroom manufacturing with polished, easy-to-clean surfaces and no hidden crevices, supporting ISO 14644 compliant environments.
Q: Can the mold be modified for different connector sizes?A: Custom modifications (core inserts, dimensional adjustments) are available to adapt the mold for various tubing diameters and connector configurations.
Q: What is the typical lead time for this mold?A: Lead time varies by customization, with standard delivery ranging from 4–6 weeks after design finalization and approval.
Q: Are the molded parts biocompatible?A: The mold is optimized for medical-grade PP materials that meet ISO 10993 biocompatibility standards, with no leachables or toxic additives in the production process.
Q: What quality testing is included with the mold?A: Full dimensional validation, mold flow analysis, and first article inspection (FAI) are provided, along with process validation documents required for ISO 13485 compliance.
Yixun is the China first generation mold maker, specialize in mold and moulding, provide one-stop plastic manufacturing service, feature in building medical and healthcare device tooling.
