ANSI AAMI ISO 80369-20:2015 pdf download – Small-bore connectors for liquids and gases in healthcare applications
This annex provides a rationale for some requirements of this part of ISO 80369 and is intended for those who are familiar with the subject of this part of ISO 80369, but who have not participated in its development. An understanding of the rationale underlying these requirements is considered to be essential for their proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale for the present requirements will facilitate any revision of this part of ISO 80369 necessitated by those developments. The committee attempted to harmonize the functional test methods for the connectors of each application in this part of ISO 80369. The test method annexes in this part of ISO 80369 describe a specific test procedure for a type test, but allow for modification to specific test conditions or acceptance criteria as necessary for each application. Many of the test methods in this part of ISO 80369 were extracted from the ISO 594- series of standards. The committee attempted to minimize changes to these test methods. However, changes were made to test methods which contained subjective acceptance criteria. The assembly procedure in each Annex mimics the assembly procedure that was extracted from ISO 594. An additional clarification was made for connectors with a floating or rotatable locking collar. Test sample preconditioning and environmental test condition requirements were added to each Annex. NOTE Manufacturer should also consider performing functional performance testing using a representative sample of the SMALL BORE CONNECTOR being evaluated with a representative sample of appropriate mating connectors.
The ease of assembly test method that was part of the ISO 594- series has been removed as a requirement from the application parts of ISO 80369 and is not present in this part of ISO 80369. The acceptance criterion of the ISO 594- series for ease of assembly was subjective. It was underdefined for a standardized test method, i.e. “a satisfactory fit” is not repeatable. Furthermore, the intent of the ease of assembly test was to ensure that the user can complete the connection using the mating halves of the connector. This requirement is satisfied by the requirement for usability validation for all new connectors being added to ISO 80369. Therefore, the ease of assembly test method has been omitted from the ISO 80369- series of standards. This part was given the −20 designation to leave space for connectors in new applications that might be developed in the future using the numbers ISO 80369-8 through ISO 80369-19.
Temperature and humidity preconditioning requirements from ISO 594-1 and ISO 594-2 also have been added in the test methods for hygroscopic materials, as these materials are known to absorb moisture from surrounding gases and liquids, which can alter physical characteristics, dimensions, and performance of connectors. The temperature range specified for testing is identical to that specified in ISO 594-1 and ISO 594-2. However, it is permitted to utilize different ranges if specified in the relevant application part of these series of standards, to evaluate the performance of connectors exposed to heated solutions and outdoor conditions.