Same facility that manufactures our 3-way stopcocks, IV manifolds, and contrast catheter hubs. ISO 13485-certified injection molding with full dimensional validation per ISO 594.
EKINSUN manufactures Luer connectors and medical tube fittings in our ISO 13485-certified injection molding facility — the same production environment used for our stopcocks, manifolds, and catheter hubs. We supply standard ISO 594 connectors in stock, and develop custom connector geometries from client drawings for OEM medical device manufacturers.
| Connector types | Female Luer-lock / Male Luer-lock / Luer-slip / Y / T / Stopcock / Custom |
| Standards | ISO 594-1 / ISO 594-2 / ISO 80369 |
| Materials | Polycarbonate (PC) / Polypropylene (PP) / ABS |
| Standard pressure rating | 300 kPa (43 psi) - ISO 594 compliant |
| High-pressure version | 8.3 MPa (1200 psi) - contrast injection rated |
| Colors available | Clear / White / Blue / Green / Yellow / Red / Orange / Custom |
| Biocompatibility | USP Class VI - ISO 10993 |
| Sterilization compatibility | EO / Gamma / Autoclave (material dependent) |
| Stock MOQ | 1,000 pcs per SKU |
| Custom mold MOQ | 10,000 pcs (new tooling) |
| Stock lead time | 5 to 7 business days |
| Custom tooling lead time | 3 to 4 weeks (tooling) + 2 to 3 weeks (production) |
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Luer-lock vs Luer-slip — Full Technical Comparison
| Property | Luer-lock (ISO 594-2) | Luer-slip (ISO 594-1) |
|---|---|---|
| Connection mechanism | Threaded collar - mechanical lock | Friction taper only |
| Pull-off resistance | High - specified in ISO 594-2 | Low - friction only |
| Rotation resistance | High - thread engagement | Low |
| Pressure rating | Up to 1200 psi (HP version) | Low pressure only |
| Connection speed | Slightly slower (thread rotation) | Fast (push-on) |
| Misconnection risk | Lower | Higher |
| Recommended use | IV therapy, contrast, pressure applications | Sampling, irrigation, low-risk |
| ISO 80369 compliance | Available in NRFit versions | Available in NRFit versions |
Product Line Overview
Standard Stock Connectors (ISO 594)
Our standard range covers the most commonly sourced Luer connector configurations used in IV therapy, contrast imaging, and general medical device assembly. All in stock for same-week dispatch from 1,000 pcs MOQ:
- Female Luer-lock — accepts male Luer taper with threaded collar; used as device output port
- Male Luer-lock — threaded collar male taper; used on syringe tips and catheter hubs
- Y-connector Luer-lock — splits one input into two outputs; used in IV manifolds and dual-line setups
- T-connector Luer-lock — three-port T configuration; used for sampling ports and bypass lines
- Luer-slip female — friction-fit female seat; used for low-pressure sampling and irrigation
High-Pressure Contrast Injection Connectors (1200 psi)
Standard ISO 594 connectors are not rated for the 1200 psi pressures used in CT and MRI power injection. Our high-pressure contrast injection connectors use PC material with increased wall thickness and a validated bonding process for the Luer taper-to-body joint. These are the connectors used in our high-pressure extension tubes and contrast injector kits.
ISO 80369 (NRFit) Connectors
ISO 80369 defines a family of small-bore connectors designed to be incompatible with each other and with standard Luer connectors — preventing accidental misconnections between intravascular, enteral, neuraxial, and respiratory systems. EKINSUN manufactures ISO 80369-20 (intravascular and hypodermic) NRFit connectors for medical device manufacturers requiring compliance with the latest EU MDR and FDA guidance on misconnection prevention.
Custom Connector Development Process
- NDA — signed before receiving any proprietary drawings or specifications
- DFM review — design for manufacturability assessment, draft angle optimization, gate location recommendation
- Tooling quotation — 5 to 7 business days after receiving approved drawing
- Mold fabrication — 3 to 4 weeks; single-cavity or multi-cavity depending on volume requirement
- First article — 20 to 30 sample units with full CMM dimensional report
- Client approval — physical samples and FAR sent for sign-off
- Production — 2 to 3 weeks after approval; batch CoA supplied
EKINSUN manufactures Luer connectors in the same ISO 13485-certified facility as our 3-way stopcocks, IV manifolds, and OEM Luer lock connectors. Single-supplier sourcing for your complete IV and contrast imaging disposable range.
Related Products
HP Extension Tube
T/Y type, 1200 psi rated
HP Injector Set
CT/MRI complete kit
Contrast Catheter
Luer-lock hub, 4Fr to 8Fr
3-Way Stopcock OEM
Luer-lock/slip
IV Manifold OEM
Multi-port Luer assembly
Frequently Asked Questions
Luer-lock connectors have a threaded collar that screws onto a matching female fitting, creating a secure mechanical joint that resists pull-off and rotation. They are required for any application with significant pressure, flow rate, or vibration — including IV lines, contrast injection, and pressurized drug delivery. Luer-slip (or Luer-taper) connectors rely on friction only between the male taper and female seat. They are simpler and faster to connect but can disconnect under pull force or pressure. Luer-slip is appropriate for low-pressure, low-risk applications such as general sampling and irrigation. See our related guide: Luer Lock vs Luer Slip.
Our standard Luer connectors comply with ISO 594-1 (Luer-slip) and ISO 594-2 (Luer-lock) for dimensional and pull-off force requirements. We also manufacture connectors to ISO 80369, which is the newer small-bore connector standard designed to prevent misconnections between different medical device systems (enteral, neuraxial, respiratory, intravascular). Specify the standard required at inquiry.
Materials available: polycarbonate (PC), polypropylene (PP), and ABS. PC is recommended for high-pressure contrast injection applications due to its superior impact strength and pressure resistance — rated to 8.3 MPa (1200 psi) in our high-pressure version. PP is preferred for general IV and drug delivery applications where chemical resistance to certain solvents is needed. ABS is used for cost-sensitive applications with moderate pressure requirements. All materials meet USP Class VI and ISO 10993 biocompatibility standards.
Standard Luer-lock connectors (ISO 594): 300 kPa (43 psi) minimum pull-off and torsion resistance per ISO 594-2. Our high-pressure contrast injection version: 8.3 MPa (1200 psi) working pressure, designed for use in high-pressure extension tubes and power injector circuits. Specify the pressure requirement at inquiry — the two versions use different wall thickness and material grades.
Yes. We accept client drawings in STEP, IGES, PDF, or DXF format. Custom connector geometries include: non-standard taper angles, proprietary thread profiles, overmolded soft-grip versions, multi-port manifold integrations, and color-specific configurations. NDA signed before receiving any proprietary design files. First article report (FAR) with CMM dimensional data supplied before production commitment. New tooling MOQ is 10,000 pcs.
Stock connectors (standard ISO 594 Luer-lock and Luer-slip in PC/PP): 1,000 pcs per SKU, ships in 5 to 7 business days. Custom tooling (new mold for non-standard geometry): 10,000 pcs minimum production run after tooling approval. Tooling lead time: 3 to 4 weeks. Production lead time after tooling approval: 2 to 3 weeks.
Yes. We can supply fully assembled and EO-sterilized kits combining tubing, Luer connectors, and other components under your private label. This is common for contrast catheter kits, IV extension sets, and irrigation kits. Assembly is performed in our ISO 13485 cleanroom environment with validated assembly processes.
Standard colors: clear, white, blue, green, yellow, red, and orange. Custom Pantone color matching available from 5,000 pcs per color. Color coding is commonly used to indicate catheter Fr size, pressure rating, or product type. All colorants used are FDA-listed pigments compatible with ISO 10993 biocompatibility requirements.
Yes. Our standard Luer connectors are designed to accept standard medical tubing inner diameters commonly used in IV sets, contrast extension tubes, and irrigation lines. Custom tubing OD configurations can be accommodated. We also supply compatible tubing materials (PVC, PE, PP, silicone) as part of complete kit assemblies.
Certificate of analysis (CoA) per batch with dimensional data, material certification confirming USP Class VI and ISO 10993 compliance, ISO 13485 manufacturing certificate, and country of origin documentation. For sterilized assemblies, EO sterilization certificate is added. Full technical file available under NDA.