ISO 594/1-1986(E) (obsolete – replaced by ISO 80369-7)

ISO 594/1-1986(E) Scope and Field of application:

A Luer is a conical fitting with 6% taper for use with hypodermic syringes and needles as well as other medical equipment for transfusion and infusion sets.

ISO 594/1 specifies the general requirements of conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. ISO 594/2 covers the lock fittings for above. The first edition of ISO 80369-7 cancels and replaces ISO 594-1:1986 and ISO 594-2:1998, clauses, sub clauses, tables, figures, and annexes of which have been consolidated and technically revised.

ISO 594/1 covers conical fittings made of rigid and semi-rigid materials and includes test methods for performance. Glass and metal would be considered typical rigid materials while plastic materials would be considered as semi-rigid although the wall thickness is an important factor in determining the rigidity of a component.

For gauging of 6% (Luer) conical fittings the small end of the male conical fitting shall lie between the two limit planes of the gauge and the larger end of the tapered portion shall extend beyond the datum plane of the gage. There should be no evidence of rocking between the gage and the fitting made of the rigid material. The two plane limits of the gauge should be positioned between the plane of the maximum diameter at the opening of the female conical fitting.

Testing for liquid leakage, air leakage, separation force and stress cracking should be performed as described in section 5.2 – 5.5.

Figure 3 in ISO 594/1 illustrates the gauges for testing rigid and semi-rigid male conical fittings as well as female conical fittings of all material. Figure 4 illustration is of the reference steel female fitting and figure 5 is of the reference steel male fitting.

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