ISO 594/1; Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and certain other Medical Equipment – Part 1: General Requirements
ISO 80369-7:2016 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.
ISO 594/1 Scope and field of application
This part of ISO 594 specifies requirements for conical fittings with a 6 % (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use such as transfusion and infusion sets.
It covers conical fittings made of rigid and of semi-rigid materials and includes Test Methods for gauging with Gages and Reference Connectors (Fittings) for Performance Testing. It excludes provision for more flexible or elastomeric materials.
Below is a list of the obsolete ISO 594/1 paragraph 4 Requirements with conversion to the new ISO 80369-20 Test Methods.
ISO 594/1 paragraph 4.1 Gauging
Gauging is not discussed in ISO 80369-20. The historical gauging test methods are retained for reference in ISO 80369-7 Annex H.
ISO 594/1 paragraph 4.2 Liquid Leakage Test
The obsolete ISO 594/1 paragraph 4.2 Liquid Leakage Test is replaced by ISO 80369-20 Annex C: Falling Drop Positive-Pressure Liquid Leakage Test Method.
Per ISO 80369-20; Annex A; Paragraph A.2; Page 4; Annex C Falling drop positive-pressure liquid leakage test method: This liquid leakage test method is performed in the same manner as in the ISO 594- series.
ISO 594/1 paragraph 4.3 Air Leakage Test
The obsolete ISO 594/1 paragraph 4.3 Air Leakage Test is replaced by ISO 80369-20 Annex D: Subatmospheric-Pressure Air Leakage Test Method.
Per ISO 80369-20; Annex A; Paragraph A.2; Page 4; Annex D Subatmospheric-pressure air leakage test method: This subatmospheric-pressure air leakage test method is a new test method that was not part of the former ISO 594- series. The ISO 594- series test method for subatmospheric-pressure (ISO 594-1, 5.3 and ISO 594-2, 5.3) creates an unspecified subatmospheric test pressure and asks the observer to look for continued formation of bubbles of an unspecified size.
ISO 594/1 paragraph 4.4 Separation Force Test
The obsolete ISO 594/1 paragraph 4.4 Separation Force Test is replaced by ISO 80369-20 Annex F: Resistance to Separation from Axial Load Test Method.
Per ISO 80369-20; Annex A; Paragraph A.2; Page 5; Annex F Resistance to separation from axial load test method: This resistance to separation from axial load test method is performed in the same manner as in the ISO 594- series. The title and principle have been elaborated to describe the intent of the test.
ISO 594/1 paragraph 4.5 Stress Cracking Test
The obsolete ISO 594/1 paragraph 4.5 Stress Cracking Test has been replaced by ISO 80369-20 Annex E: Stress Cracking Test Method.
Per ISO 80369-20; Annex A; Paragraph A.2; Page 4; Annex E Stress cracking test method: This stress cracking test method is performed in the same manner as in the ISO 594- series. The acceptance criteria have been changed to require passing a functional leak test after the stress cracking test method has been performed.
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final decisions on the data provided in the root documents: ISO594/1:1986; ISO 594/2:1998; ISO80369-7:2016; and ISO80369-20:2015 which are copyrighted documents. To purchase copies visit
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Original Posting: 10/29/2012
Last Revision: 11/14/2016
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