Engineering Excellence in Scalp Vein Sets & Vascular Access Manufacturing
In modern clinical infusion therapy and hemodialysis management, the single-use scalp needle—commonly referred to as a scalp vein set or butterfly needle—is an indispensable vascular access device. Designed for rapid venipuncture, pediatric fluid administration, geriatric blood sampling, and continuous low-flow intravenous therapies, the structural integrity of the needle tip, wing flexibility, and lumen smooth bore directly govern clinical safety and patient comfort.
As a leading China scalp needle manufacturer and international exporter, our production methodology integrates advanced Japanese needle cannulation engineering with automated siliconization processes. By utilizing SUS304 medical-grade stainless steel with ultra-thin wall (UTW) geometry, our scalp vein sets achieve maximum inner flow diameter without compromising mechanical puncture stiffness.
Clinical Insight: The penetration force of a scalp vein needle is heavily dictated by bevel grind geometry and surface tribology. Our automated triple-bevel grinding system reduces initial skin insertion drag by up to 35% compared to standard double-bevel alternatives, significantly mitigating tissue trauma and hematoma risks.
Technical Anatomy of a High-Performance Scalp Vein Set
Every single-use scalp vein assembly consists of four critical engineered components, strictly adhering to ISO 6009 and ISO 10993 standards:
- Triple-Bevel Siliconized Stainless Steel Cannula: Formulated with medical-grade dimethicone coating to minimize friction coefficient during vascular entry.
- Color-Coded Flexible Butterfly Wings: Molded from medical PVC or non-phthalate elastomers, featuring tactile ridges for secure non-slip clamping during insertion and anatomical flat seating during fixation.
- Kink-Resistant Medical PVC/TPU Tubing: High-clarity, DEHP-free transparent tubing ranging from 15cm to 30cm, allowing immediate visual detection of blood flash-back while maintaining elasticity under bending pressures.
- Precision Luer Lock / Slip Connector: Female Luer fitting compliant with ISO 80369-7, outfitted with a protective cap to ensure hermetic sealing prior to line connection.
Standardized Scalp Needle Gauge Specification Matrix
To support global hospital procurement and tender requirements, our scalable production lines manufacture scalp needles across full ISO 6009 color-coded spectrums:
| Needle Gauge (G) | ISO Color Code | Outer Diameter (mm) | Inner Diameter (mm) | Tubing Length (mm) | Primary Clinical Application |
|---|---|---|---|---|---|
| 18G | Pink | 1.20 mm | 0.84 mm | 300 mm | Rapid blood transfusion, high-viscosity fluid infusion |
| 19G | Cream / Ivory | 1.10 mm | 0.76 mm | 300 mm | Surgical fluid bolus, large vein access |
| 20G | Yellow | 0.90 mm | 0.60 mm | 300 mm | Routine adult IV therapy & diagnostic blood draw |
| 21G | Deep Green | 0.80 mm | 0.51 mm | 300 mm | General hospital ward administration, pediatric bolus |
| 22G | Black | 0.70 mm | 0.44 mm | 300 mm | Fragile vein infusion, oncology & geriatric care |
| 23G | Deep Blue | 0.60 mm | 0.37 mm | 300 mm | Pediatric venipuncture, scalp vein access in neonates |
| 25G | Orange | 0.50 mm | 0.28 mm | 300 mm | Neonatal intensive care unit (NICU), delicate vessels |
| 27G | Grey | 0.40 mm | 0.21 mm | 300 mm | Micro-infusion, specialized pediatric diagnostic sampling |
Manufacturing Integrity: Cleanroom Automation & Quality Assurance
Quality reliability is non-negotiable when exporting sterile medical disposables. Our manufacturing complex in China spans over 100,000 square feet of certified ISO Class 7 and Class 8 cleanrooms operating under rigid ISO 13485 quality management systems. Every batch of scalp needles and dialysis catheter kits undergoes stringent automated optical inspection (AOI) for bevel burr detection, lumen blockage, and silicone uniformity.
Sterilization processes utilize strictly monitored Ethylene Oxide (EO) gas chambers compliant with ISO 11135 guidelines. Residual EO limits are systematically verified through gas chromatography to levels far below 10 ppm, guaranteeing non-pyrogenic, non-toxic, and biocompatible performance upon arrival at international healthcare facilities.
