In May, 2021, ISO published the updated 80369-7 standard. ISO first published ISO 80369 Part 7 in October, 2016 as the replacement to ISO 594, the standard governing dimensions and performance requirements of Luer connectors.
Following are some of the highlights of the updated 80369-7:2021 standard:
- Two different categories for material’s modulus of elasticity:
- Semi-Rigid (700 MPa to 3,433 MPa)
- Rigid (Greater than 3,433 MPa)
- Remove the need to ASTM D638 and ASTM D790 in the luer testing. The standard now leans on the requirements of ISO 80369-1:2018 for this part of testing.
- Update references to the new versions of standards, Specifically ISO 80369-1:2018
- Unscrewing torque range has been revised to 0.018 – 0.020 N·m
- The tolerances for specific dimensions across Annex B have been updated based on the type of material (semi-rigid or rigid) used to manufacture parts
- Some dimensions are now considered to be auxiliary
- Some tolerances were loosened to make it easier to manufacture the parts.
- The dimensional tolerances have loosened, easier to calibrate and manufacture
- Note: this does not affect DDL’s calibrated reference connectors
Starting with the publication of ISO 80369-7 in October 2016, the FDA gave manufacturers a three-year grace period to show that parts previously compliant with ISO 594 are now compliant with ISO 80369. Originally the FDA stated it would no longer accept submissions showing conformance to ISO 594 after December 31, 2019. The FDA has since extended the deadline to December 17th, 2023.
The European Union’s joint technical committee is working with ISO on the development of the ISO 80369 series of standards to ensure requirements from the EU directives are met and the standards can be accepted by the EU. Currently the EU has withdrawn the previous versions of the Luer testing standards and as of May 31, 2020 they will no longer accept submissions to the previous versions of the standards.
Once updates are completed to a standard, the EU will give one year before withdrawing the previous version of the standard and requiring compliance with the currently accepted version of a standard.
For more information on ISO 80369-7, please download our white papers “ISO 80369-7: Changing the Standard for Luer Connectors” or “ISO 80369 FAQs”.
Please contact us if you have further questions or need help with an upcoming test project.