ANSI AAMI ISO 80369-7:2016 pdf download – Small-bore connectors for liquids and gases in healthcare applications
The reference CONNECTORS for evaluation of the NON – INTERCONNECTABLE characteristics are described in Annex C. Where the design of a LUER CONNECTOR of this part of ISO 80369 relies on dimensions or features of the MEDICAL DEVICE or ACCESSORY to ensure NON – INTERCONNECTABLE characteristics, the NON – INTERCONNECTABLE characteristics shall be VERIFIED . Check compliance by applying the tests of ISO 80369-1:201 0, 5.1 , and ISO 80369-1 :201 0, Annex B. Compliance may be shown by applying a computer aided design (CAD) analysis of the dimensions of all of the ISO 80369- series SMALL BORE CONNECTORS and the SMALL BORE CONNECTOR under test, in conjunction with physical testing of the SMALL BORE CONNECTOR per Annex B where the CAD analysis does not demonstrate the NON – INTERCONNECTABLE characteristics. When necessary, the SMALL – BORE CONNECTOR may be installed on the MEDICAL DEVICE or ACCESSORY to demonstrate compliance with the NON – INTERCONNECTABLE characteristics test requirements of ISO 80369-1 :201 0, Annex B. NOTE 1 M EDICAL DEVICES using the LUER CONNECTORS of this part of ISO 80369 that do not rely on the dimensions or features of the MEDICAL DEVICE or ACCESSORY to ensure NON – INTERCONNECTABLE characteristics are presumed to comply with the NON – INTERCONNECTABLE characteristics test requirements of this part of ISO 80369. NOTE 2 The summary of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION is provided in Annex D. NOTE 3 The summary of the usability requirements for LUER CONNECTORS is provided in Annex E.
The separate set of dimensions previously identified for SEMI – RIGID MATERIALS and RIGID MATERIALS are now merged into one set of dimensions. With modern test equipment and TEST METHODS , it is now practicable to define the dimensions with greater precision, thereby eliminating the need for gauging for the purposes of a TYPE TEST . Legacy Luer gauges cannot be used to verify the performance of CONNECTORS that are intended to prevent misconnection because they lack the dimensions for surfaces not intended to form CONNECTIONS with LUER CONNECTORS . Maintenance of production quality (i.e. using gauges) is outside the scope of this part of ISO 80369. The dimensional requirements in Annex B are a more precise description of the design and performance characteristics for both intended CONNECTIONS and avoidance of misconnections. Dimensions and tolerances not previously identified in ISO 594-1 and ISO 594-2 are added to this part of ISO 80369 to reduce the RISK of misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS with non- LUER CONNECTORS that are being developed under other parts of the ISO 80369- series. These new requirements were selected to represent the inherent design and dimensions of LUER CONNECTORS in clinical use at the time this part of ISO 80369 was developed. Since the configurations of the CONNECTORS proposed within ISO 80369-7 are SMALL – BORE CONNECTORS with or without a threaded collar, the requirements and parameters from ISO 594-1 and ISO 594-2 have been used where applicable.