The growing abundance of Luer connections in the healthcare industry has led to interconnectibility issues between incompatible equipment. In response to the associated risks (e.g. leaks), a unified standard from the International Standards Organization (ISO) that regulates all small bore medical connectors has been produced: ISO 80369, which in part has been recently updated (ISO 80369-7:2021). Smithers offers Luer testing to ISO 80369, which can ensure that your Luer fittings and connectors meet the general requirements for small bore connectors.

Luer Small Bore Connectors Overview
The patented ‘Luer’ fitting, featuring male and female connectors, has been in use since the late 1800’s to make secure, friction-based connections between medical devices and equipment and patients. Luer assemblies are regularly used in delivery systems for liquid and gases in healthcare applications including, but not limited to, intravascular or hypodermic applications as well as enteral feeding and other enteral applications.
Luer connections are conical fittings with a 6% taper, are made of rigid/semi-rigid materials, and are primarily used with hypodermic syringes and needles and certain other medical apparatuses. ISO 594, first published in 1967, provided standard specifications for conical Luer fittings. The standard was produced to regulate dimensional and functional characteristics. In 1986, the standard was updated and separated into Part 1 (Luer Slip Fittings) and Part 2 (Luer Lock Fittings).
ISO 80369
ISO 80369 features six separate application sections, each associated with a specific healthcare use. Each application section contains regulatory requirements and test methods which can be employed to demonstrate conformity to the standard. The Smithers MDT Physical Testing team can conduct all testing required by ISO 80369, including method development and validation, third party assistance during design verification testing, and support of a regulatory submission and batch release.

The ISO 80369 series has been split in to three main sections: Requirements, Methods and Application:

ISO 80369-1 specifies the requirements necessary to verify the designs of small bore connectors to ensure that:
• They do not misconnect with other small bore connectors, and;
• They safely and securely connect with their mating half
Connectors which comply with the appropriate application part of ISO 80369 will be dimensionally incompatible with any connector for other applications identified in the standard.

ISO 80369-20 contains the common test methods to support the assessment of the performance requirements for small bore connectors. They can be used in conjunction with the relevant application standard of ISO 80369 to specify the test and appropriate conditions required to claim compliance with the standard.

Test Modifications
The testing specified in ISO 80369-20 are ‘Attribute tests’; they each give a Pass/Fail result. However, these tests have been designed to be suitable for modification to capture variable data. Variable test data gives more detail than attribute tests i.e. can be quantified and can help with small sample sizes. Smithers MDT Limited can advise on how this data can be used, adapted to variable data and support with replicate / sample amounts, even if limited quantities are available.

To demonstrate conformance to the ISO 80369, testing would use the specified reference Luer connectors within the standard. However, guidance from regulatory bodies, as well as ISO13485 states that where products (such as syringes) connect to other medical devices (via a Luer for example), they must be tested to show compatibility with each other. Conformance to each standard alone will not ensure connectivity to connected devices without performance failure.
Common Test Samples:
Samples including (but not limited to):
• Clave Connectors
• Medical Check Valves
• Reconstitution Systems
• Panel Mounts & Manifolds
Tubing Connectors

Smithers Medical Device Testing has a deep knowledge and experience of working with Luer assemblies, combination devices and ‘co-packs’ to demonstrate compatibility and can advise on project design and validations. If you have any questions or would like to discuss further, please speak to your Smithers representative or contact us via the expert links on this page.

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