ISO 18250-3 Testing - Medical Device Inspection

What is ISO 18250-3?

ISO 18250-3 is the medical connector standard for reservoir delivery systems in enteral applications, like feeding tubes for administering or removing fluid. Manufacturers need to conduct testing or find a third party medical device inspection lab that can ensure their products are meeting the stated dimensional requirements.

The ISO 18250-3 standard is similar to those of the medical Luers, but the enteral reservoir connectors for medical devices do not fall under the same definition of small-bore connectors. Therefore, a standard was formed to take into consideration the risk of misconnection with other medical devices like IV’s. ISO 18250-3 testing can be conducted by an accredited dimensional inspection laboratory.

What Measurements and Tolerances are Covered in the ISO 18250-3 Requirements?

-Cross connector assembly E1R - shaft & revolving lock

-Cross connector shaft E1R

-Cross port reservoir connector E1R

-Male connector E2R

-Female connector E2R

Why is Industrial Computed Tomography (CT) Scanning a Good Fit For Medical Connector Inspection?

Internal thread measurements are much easier to conduct with industrial CT compared to other 3D scanning technologies. It is a non-destructive, x-ray technology able to reach internal or non-visible geometries in one scan. Other scanning technologies use touch probes or can only measure surface geometries. Multiple pieces can also be loaded during one scan, saving time and cost. Industrial CT scanning is accurate down to the micron level. With the medical connectors mounted on a rotating stage and the x-rays scanning them, there is no need for complicated fixturing, another time and cost saving benefit.

Nel Pretech is accredited to ISO 17025 by A2LA, making us a trusted partner for your medical device inspection needs. Get your enteral connectors tested and in compliance with ISO 18250-3. Give us a call today!

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