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.
Officially… 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.
So now what?
Below are some links which will begin to answer your questions.
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
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