ISO 594 is replaced with ISO 80369
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.
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."
Overview…
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.
Summary...
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? Discussion on the making the change from ISO 594 to ISO 80369-7. Luer Conical Taper Gages for testing both ISO 594 and ISO 80369-7. Fitment Screw Thread Gauges for testing both ISO 594 and ISO 80369-7. Reference Connectors used in testing both ISO 594 and ISO 803669-7. DUO-remarking/DUO-recalibration option for your existing ISO 594 Gages and Reference Connectors. Test Devices for the obsolete ISO 594. Test Devices for ISO 80369-20. Suggest Testing Frequency for OEM producers. | ||
Disclaimer: Comments: |