In the medical device industry, rubber components must meet stringent biocompatibility and safety standards. Our company specializes in producing medical-grade rubber parts using controlled vulcanization molding processes. Supported by a robust quality management system, we provide reliable component solutions for global medical device manufacturers.
Certifications & Compliance
Our production is grounded in international standards to ensure reliability and traceability:
ISO 9001 QMS: Governs our entire process from material procurement to delivery.
CE Mark Compliance: Products meet essential EU safety requirements for medical devices.
ROHS Compliance: Guarantees products are free of restricted hazardous substances.
Material Biocompatibility: We use ISO 10993-assessed materials and can assist with higher-level certification needs.
Controlled Production Environment
While not sterile, our dedicated production area ensures cleanliness and minimizes contamination risks:
Separate Zones: Medical and industrial component production areas are segregated.
Environmental Controls: Workshops maintain stable temperature/humidity with regular cleaning.
Trained Personnel: Staff are trained in medical product requirements and clean production protocols.
Precision Manufacturing Process
We employ tailored vulcanization molding for medical components, emphasizing precision and control:
Mold Design & Fabrication: Molds are precision-engineered for dimensional accuracy and smooth finishes, with careful attention to eliminating sharp edges and burrs.
Process Control: Vulcanization parameters (temperature, pressure, time) are strictly controlled and documented to ensure batch-to-batch consistency.
O-Rings: For large or custom sizes, we O-rings from vulcanized, ensuring material consistency and providing flexibility for small-batch needs.
Multi-Level Quality Assurance
We implement a stringent inspection regime for medical components:
Incoming Inspection: Verification of all medical-grade material certifications.
In-Process Control: Monitoring and recording of key vulcanization parameters.
Final Product Inspection: Includes dimensional checks, visual inspection, physical performance sampling, and optional cleanliness testing.
Full Traceability: Complete batch records document materials, processes, inspections, and personnel.
Primary Applications
Our components are commonly used in:
In Vitro Diagnostic Equipment (seals)
Medical Instruments (seals, washer)
Patient Aid Devices (seals, rubber parts)
medicine bottle (rubber stopper)
Comprehensive Documentation Support
We provide necessary documentation to support our customers' compliance efforts:
Material certifications and ROHS declarations
Detailed production batch records
Product inspection and test reports
Quality system certificates (ISO 9001)
Proven Application Support
Case 1: Supplied silicone rubber sealing rings for blood glucose meter test slots, meeting elasticity, longevity, and ROHS requirements. 跳转到O型圈
Case 2: Provided nitrile rubber components for infusion pumps, optimized for medication compatibility and fatigue resistance through formulation and process control. 跳转到垫圈
Commitment to Continuous Improvement
We actively integrate customer feedback into our processes through problem analysis, corrective actions, and ongoing evaluation of materials and techniques.
Conclusion
Manufacturing medical rubber components requires a careful balance of performance, compliance, and cost. Through our certified vulcanization processes, systematic quality control, and full documentation support, we deliver components that meet industry requirements and serve as a reliable partner in the medical device supply chain.
EN
