Small-Bore Connector (Luer lock) testing
Anecto have a full suite of tests for Small-Bore Connector (Luer taper and Luer lock) fittings.
Anecto’s test capabilities include the following:
- Gauging: To check the dimensions of a Luer.
- Liquid Leakage: Tests leaks under pressure.
- Air Leakage: Tests leaks under pressure.
- Separation Force: Tests attachment to the reference fitting when a load is applied.
- Resistance to Overriding: Tests the threads of the fitting.
- Stress Cracking: Tests Luer crack in the 48 hours following assembly.
- Unscrewing Torque (Luer lock only): Tests whether the sample Luer remains attached under a specific unscrewing (counter-clockwise) torque.
- Ease of Assembly (Luer lock only).
Benefits of Luer compliance testing:
- Higher quality medical devices if Luer compliant.
- Testing exposes product weaknesses.
- Better compatibility if Luer compliant.
- Air and liquid leak prevention is ESSENTIAL in medical devices.
- Exposes any issues in the moulding or machining process.
All tests are carried out by Anecto to ensure your product is compliant to international gauging standards. The gauges used by Anecto all have ISO 17025 traceable calibration. Other assembly and pressure test equipment used offer repeatable testing.
Guidance Documents / Standards:
- ISO 594-1 – Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
- ISO 594-2 – Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
- ISO 10555 – Intravascular catheters — Sterile and single-use catheters
- ISO 80369-7 – Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
Currently on the books and with a transitionary period due to end on December 31 2019, the ISO 80369 small-bore connector standards, introduced to prevent misconnections, have superceded the ISO 594 standards.
Want to know more about our testing for Small-Bore Connectors (Luers)?
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