ISO 594 is replaced with ISO 80369

2021-05-07 12:30:22

ISO 594 is replaced with ISO 80369

Overly simplified...

ISO 594 was replaced with ISO 80369-7 in 2016.

The old numbers: ISO 594/1 and ISO 594/2; have been replaced with: ISO80369-7.

The specific specification for Needle and Syringe connections is now: ISO 80369-7.

Testing using ISO 594 parameters should be supplanted by ISO 80369-7 testing.


ISO 80369-7:2016 Foreword states: "ISO 80369-7 cancels and replaces the first edition ISO 594-1:1986 and the second edition of ISO 594-2:1998, clauses, subclauses, tables, figures, and annexes of which have been consolidated and technically revised."


The new ISO 80369-7 is essentially a clerical change from the previous ISO 594. This was to allow the Needle and Syringe Luer Connectors to be included under the ISO-80369-x Non-Interconnectable Small-Bore Connector collection of specifications. ISO 80369 is where you find the patient side connectors for various disciplines/families of connections.

• The text has been harmonized to the ISO 80369 Medical Small-Bore Connector specification format.

• The defined connectors have been more clearly dimensioned.

• The testing parameters have been narrowed.


I believe the intent of the authors of ISO 80369-7 was to allow ISO 594 connectors to be 100% forward compatible with ISO 80369-7. I am 99.9% confident that any ISO 594 designed/tested connector which has passed ISO 594 measurement/testing will pass when measured/tested using the ISO 80369-7 parameters; the opposite statement is not true.

This data is provided for general information only. The intention is to provide accurate information; regardless; errors may exist in the supplied information. If accuracy is critical, base your final decisions on the data provided in the root documents: ISO594/1:1986; ISO 594/2:1998; ISO80369-7 and ISO80369-20 which are copyrighted documents.
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Original Posting: 8/29/2004
Last Revision: 2/26/2020