Manager of Physical Testing, Medical Device Testing
United KingdomContact Chris
This standard applies to any small-bore connectors where their end-use is either part of or form connections in:
This standard does not specify requirements for the medical devices which uses these connectors as part of their device. ISO 80369-20 section of this standard contains the common test methods to support the functional requirements for small-bore connectors. The other parts document the design and dimensions of small-bore connectors according to their specific application categories and provide a framework for testing connectors of different medical applications against each other to ensure non-interconnectability. ISO 80369-2 section 'Connectors for breathing systems and driving gases applications' and ISO 80369-4 section 'Connectors for urethral and urinary applications' are still under development by the International Organization for Standarization.
In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing program to meet your specific testing requirements and resolve and design or functionality issues you might have.
Please note: The information outlined above is to be used as a reference. Please refer to the appropiate competent standards agency in your country for full details and implementation of EN ISO 80369.