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Is Flow Regulator (Small) compatible with ISO 80369?

Quick Answer

Luer interfaces on the Flow Regulator (Small) (TS-001) follow small-bore connector conventions; confirm exact ISO 80369 series compatibility for your application with Baixin Bio. It is molded from ABS for IV infusion sets and tubing flow control.

Definition

A flow regulator (small) is one of the small standardized parts that make a medical fluid path work. Its job is to connect, seal or control flow between two segments of a line, and it is manufactured from device-qualified plastics for reliable single-use performance.

Because the part sits directly in the fluid path, three things matter most: a dependable seal, dimensional consistency from part to part, and a material that is compatible with the fluid and the chosen sterilization method.

To put it in context: a disposable fluid-handling device is rarely one molding. It is a chain of small components — connectors, valves, chambers, clamps, caps and tubing — assembled into a single path. Standard interfaces are what let those components come from a catalog and still fit, which is the whole reason this category of part exists.

About This Component

The Flow Regulator (Small) is supplied as a single-use molded part for IV infusion sets and tubing flow control. Its interface follows standard conventions so it mates predictably with compatible components, and it is produced in ABS by default, with other medical-grade resins available on request.

Like all Baixin Bio components, it can be customized for material, color, dimensions, packaging and assembly. For a precise specification — exact dimensions, tolerances, sterilization validation, packaging counts and minimum order quantity — request a drawing and samples through the inquiry form.

Key Advantages

The practical advantages of flow regulator (small) cluster around safety, consistency and supply:

  • Standardized interface that interoperates with compliant luer components
  • Leak-resistant seal that holds under normal line pressure
  • Single-use design that supports sterile, disposable workflows
  • Medical-grade resin selected for fluid compatibility
  • Dimensional consistency across production lots

In short, the component earns its place by being unremarkable in the best way: it fits, it seals, it is available, and it behaves the same every time, so engineering attention can go to the device rather than the fitting.

Common Applications

You will find flow regulator (small) across a range of single-use fluid-handling assemblies, including:

  • Hemodialysis circuits
  • Enteral feeding sets
  • Laboratory fluid handling
  • Irrigation sets

Across all of these uses, the underlying requirement is the same: a connection that is secure, leak-resistant and safe to make once and discard. That is why standardized, single-use molded components dominate the category — they remove variability from the most failure-prone part of a fluid path, the junction, and they let a device be assembled quickly and qualified as a unit.

How to Specify and Choose

A good specification answers a short list of questions up front:

  • Packaging format and order volume for the program
  • The connection standard the mating part uses (luer slip, luer lock or a specific ISO 80369 series)
  • The working pressure the junction must hold without leaking or separating
  • The fluid and its chemical compatibility with the candidate resin
  • The inner and outer diameters of the tubing the part bonds to

Getting these settled early means the first samples are usable and the program moves to volume faster. When a standard part does not fit, the same variables become the brief for an OEM or ODM tooling project.

Industry Standards

Two standards questions dominate this category: connection geometry and sterilization. Connection geometry is increasingly defined by the ISO 80369 series, which separates applications so incompatible lines cannot mate; sterilization is handled by validated EO, gamma or steam autoclave processes matched to the resin and the device.

For ABS components, the practical sterilization options are EO and gamma; the choice is confirmed against the finished device and its validated process.

The reason the standards landscape moved toward ISO 80369 is patient safety: when every line used the same luer taper, it was physically possible to connect, say, an enteral line to an intravenous one. The newer series give different applications deliberately incompatible geometries so a dangerous misconnection cannot be made by accident. For a component maker, that means confirming which series an application requires before specifying a part.

This page is informational and does not replace device-specific regulatory or validation guidance. Confirm exact standards, biocompatibility and sterilization requirements for your product with your quality team and your supplier.

Frequently Asked Questions

Can I request samples?

Yes. Samples and drawings are welcome and recommended before committing to volume. Use the inquiry form to request them.

Is flow regulator (small) available for OEM or ODM projects?

Yes. Baixin Bio manufactures to drawings and samples, customizing material, color, dimensions, packaging and assembly. Send your specification for a quote.

What materials are used?

Depending on the part, medical-grade PC, PP, PVC, ABS, PE or POM is used, selected for the connection method, fluid path and sterilization requirement.

How is it sterilized?

Components are compatible with validated single-use sterilization such as ethylene oxide, gamma irradiation or steam autoclave, depending on the resin. Confirm the method for your device.

Is it compatible with ISO 80369?

Luer interfaces follow small-bore connector conventions. Confirm exact ISO 80369 series compatibility for your application with Baixin Bio before specifying.

What order volumes are supported?

Baixin Bio supplies disposable device assemblers in production volumes, with consistent lot-to-lot quality and export-friendly communication.

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Need Medical Connectors or Components?

Baixin Bio manufactures luer connectors, valves, drip chambers, clamps, caps and tubing, with OEM and ODM customization. Send your drawings or samples for a quote.

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