Subtitle: Small-bore connectors for liquids in healthcare-How to choose luer under ISO 80369-7 and actual end application?

1, First of all, what is a luer?

A luer fitting is defined as a small, friction based, leak-proof connector. Its intended use is to connect tubing and equipment for the transfer of fluids and gases.
In one word, luer is for standard connection.

2, What standard are referred for luer? ——ISO594 vs. ISO 80369-7

In ISO594-1 and -2, luer used to being called small bore connectors. Now it is named after their inventor, 19th century German Medical Instrument maker Hermann Wulfing Luer
In the new ISO80369-7 standard, new terms Luer Connector, Luer Slip Connector, and Luer Lock Connector replaced the conflicting terms used in ISO 594.

Important Note: Difference Between Luer Lock vs. Luer Slip vs. Rotating Luer

• This kind of description are only for male luer, and the difference are in the way it connects female part.
  • Luer Lock allows for the mating part to be twisted onto the tip and locked into place.
  • Luer Slip, the other part is pushed onto the tip. Luer Lock also prevents the needle tip from accidentally falling off when injecting fluids.
  • Rotating luer, being the best of all three, allows for connection of female luer by swirling collar, without twisting connected tubing

3, What is the upgrade from ISO80369-7 to ISO594?

• ISO594 pritorize mating function while gives a sketch of size requirement.
  • In fuction speaking, it mostly means “no leaking” while connecting to other luer under certain application but it does not mean it fit the standard which means it could still have function problem if connecting to another manufactuer luer under a differnt application.
  • In short, the conclusion of compliant or not can be subjective depending the end user environment.
• Thus ISO 80369 – 7 was developed after several catastrophic incidents resulted from inappropriate, medication, liquid nutritional formula or air being administered intravenously.
  • The goal of ISO 80369-7 is to standardise connector use for common procedures.
    • It states that both dimensional and functional requirements must be met for compliance as well as the semi-rigid and rigid dimensional requirements. Very Objective data to be met
    • Unlike ISO 594-2, the new standard adds a flexural modulus of 700 MPa or higher – any softer material cannot be used for compliance to this standard.
    • ISO 80369-7 also states that by using modern test equipment and methods, it is now practical to define the dimensions with greater precision.
  • This means that component manufacturers using plastic materials must now comply with the dimensional requirements.
• In Conclusion:
• *If a luer complies with ISO 80369-7, it is backwards compatible to ISO 594.
• *If a luer that only passes performance testing (ISO 594) might not be compatible with ISO 80369-7.

All dimensional and performance requirements in ISO 80369-7 must be met to claim compliance. In new standard, there are some size are newly requested, for example, “t” size measures from the end of the male luer to the first fully formed thread.

In short, the difference is “Size Matters” under ISO80369-7

The challenging Performance required covered in ISO 80369 include the following
*Positive pressure liquid leakage.
*Resistance to separation from axial load.
*Resistance to overriding.

4, Which material should I use for luer in plastic area?

In our world, most luer are made in plastic thus in the category of semi-rigid material, as indicated by ISO594 and ISO80369-7 which could be:

• PC-Polycarbonate
• ABS-Acrylonitrile Butadiene Styrene
• PE-Polyethylene
• PP-Polypropylene
• PVC-Polyvinyl Chloride

Each material of luer can meant for differnt purpose:

• PC Luer——Super alcohol resistant, does not crack easily under extreme cases, Need to be bonded in certain technique
• ABS Luer——Super bond material, need to be preannealled to avoid cracking
• PE Luer——High Pressure Application Recommended
• PP Luer——Great partner with bulb for injection purpose
• PVC Luer——Ultimate choice for most application, crack free, not applied for total PVC-free set

Besides those options, the tapered male & female luer connectors are recommended for connecting silicon tubing.

Here at Simplest Medical we guarantee for the luer:
1, ISO80369-7, Dimensional Conformity,
2, Translucent and Crack Free
3, Easy and right size bonding
4, Bio capability safe for a small luer

It is recommended to contact your sales communicating your intended use for the luer to choose the correct type.

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