ISO 80369-7 replaces ISO 594-2:1998(E)

Small-bore connectors for liquids and gases in healthcare applications

Part 7:

Connectors for intravascular or hypodermic applications

This part of the ISO 80369-7 standard encompasses significant technical revisions to ISO 594-1 and ISO 594-2.

ISO 80369 – 7 was developed after several catastrophic incidents resulted from inappropriate, medication, liquid nutritional formula or air being administered intravenously.

ISO 80369 was developed to prevent misconnection between SMALL-BORE CONNECTORS used in a range of applications. ISO 80369-1 details the requirements to verify the designs and dimensions of SMALL-BORE

CONNECTORS to ensure they do not misconnect with other SMALL-BORE CONNECTORS and that they secure safely and securely with the mating half.

The scope of ISO 80369-7:2016(E) specifies the dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

Dimensional requirements for Luer Connectors shall comply with dimensions and tolerances given in the following:

Figure B.1 and Table B.1 for male Luer Slip Connector (L1)

Figure B.2 and Table B.2 for female Luer Slip Connector (L1)

Figure B.3 and Table B.3 for a male Luer Lock Connector (L2), with fixed Collar

Figure B.4 and Table B.4 for a male Luer Lock Connector (L2), with floating or rotatable collar

Figure B.5 and Table B.5 for a female Luer Lock Connector (L2),

Figure B.6 and Table B.6 for a female Luer Lock Connector (L2), variant A

Figure B.7 and Table B.7 for a female Luer Lock Connector (L2), with lugs at right angle to axis, variant B

Figure B.8 and Table B.8 for female Luer Lock Connector (L2), with lugs at right angle to axis (L2), variant C

Performance required covered in ISO 80369 include the following

Fluid Leakage
Leakage by pressure decay
Positive pressure liquid leakage
Sub-atmospheric pressure air leakage
Stress cracking
Resistance to separation from Axial Load
Resistance to separation from unscrewing
Resistance to overriding

The new terms Luer Connector, Luer Slip Connector, and Luer Lock Connector replace conflicting and confusing terms used in ISO 594-1 and ISO 594-2. The new terms are equivalent to those now generically used to describe the Small Bore Connectors commonly named after their inventor, 19th century German medical instrument maker Hermann Wulfing Luer.

The separate dimensions previously identified for Semi-Rigid Materials and Rigid Materials are now merged into one set of dimensions. Utilizing modern test methods and equipment has eliminated the need for gaging for the purpose of type test as the dimensions are defined with greater precision in this standard.

Legacy Luer gauges cannot be used to verify a connector’s performance in regard to preventing misconnection. Annex B of ISO 80369-7 offers a more precise description of the design and performance characteristics for both intended connections and avoidance of misconnections.

ISO 994-1 and ISO 594-2 lack specific dimensions and tolerances that are now detailed in ISO 80369. Since the designs of the Connectors proposed in ISO 80369 are Small Bore Connectors both with and without the threaded collar, ISO 594-1 and ISO 594-2 requirements and parameters are used where applicable.
Annex C of ISO 80369-7 specifies the general requirements for Reference Connectors

Figure C.1 – Female reference Luer Lock Connector for testing Luer Lock Connectors for leakage, separation from unscrewing, stress cracking and Non- Interconnectable characteristics.

Figure C.2 – Male reference Luer Slip Connector for testing female Luer Connectors for leakage, separation from Axial load, stress cracking and Non-Interconnectable characteristics.

Figure C.3- Female reference Connector for testing male Luer Lock Connector for separation from Axial load and resistance to overriding.

Figure C.4 – Male reference Luer Lock Connector for testing female Luer Connectors for leakage, separation from unscrewing, stress cracking and Non-Interconnectable characteristics.

Figure C.5 – Female reference Luer Slip Connector for testing male Luer Connectors for leakage, separation from axial load, stress cracking and Non-Interconnectable characteristics.

Figure C.6 – Male reference Connector for testing female Luer Lock Connector for separation from Axial load and resistance to overriding.

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