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Anecto tests to ISO 80369-7!

Posted in Corporate News Medical & Life Sciences News on 7th November 2017

Do your Luer connectors comply with the new ISO 80369-7 requirements?

Anecto can help validate and challenge all luer types and we have a full offering of ISO 17025 accredited performance tests.
In line with Anecto’s constant development and dedication to be at the highest levels of conformance in medical device testing, we can now announce that we are accredited to test to ISO 80369-7 & ISO80369-20.

ISO 80369-7 is the new standard for luer fittings (small-bore connectors for liquids and gases in healthcare applications, specifically connectors for intravascular or hypodermic applications).

Luer lock, Luer lock test, luer taper, conical lock, ISO 594-1, ISO 594-2, guaging, liquid leakage, air leakage, separation force, stress cracking, Unscrewing torque, ease of assembly, resistance to overriding

The new standard replaced the ISO 594-1/-2 standards this year and is currently on the books, with a transitionary period due to end on December 31 2019.

New requirements include:

  • Updated performance tests according to ISO80369-7/20:
    1. Fluid Leakage
    2. Sub-Atmospheric Pressure Air Leakage
    3. Stress Cracking
    4. Resistance to Separation from Axial Load
    5. Resistance to Separation from Unscrewing
    6. Resistance to Overriding
  • New dimensional tolerance verification
  • Injection moulding process validation
  • Accelerated ageing studies
  • Bespoke test design including over-torque, flow, high pressure and simulated use

For more information…

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