ISO 594-2 covers conical lock fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment. The standard covers rigid and semi rigid materials and details the test methods.
Scope: ISO 594-2 specifies requirements for conical lock fitting with a 6% (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use such as transfusion equipment.
ISO 594-2 requirements pertain to fittings made of rigid and semi-rigid materials and include the testing methods and procedures. ISO 594-2 excludes provisions for more elastomeric or flexible materials. It is difficult to define with accuracy the characteristics of rigid and semi-rigid materials but plastics in general would be considered semi-rigid and metal and glass would be considered rigid.
ISO 468, Surface roughness – parameters, their values and general rules for specifying requirements
ISO 594-1:1986, Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment-Part1: General requirements.
ISO 7886-1, sterile hypodermic syringes for single use-Part 1: Syringes for manual use.
Dimensions and tolerances:
Per ISO 594-1, the dimensions and tolerances for the female and male conical fittings apply to the relevant conical part of the fitting described in clause 4 of ISO 594-2.
(α) The rigid male and female lock fittings illustrated in Figures 1 to 4 are specified in table 1. The thread angles or lug bearing surface against separation with the plane perpendicular to the axis of the lock fitting is 25° + 5° - 0 for Figures 1, 2, 3a, 3b, 3c, and 4.
(β) The internal thread minimum angle non-bearing surface against separation with the plane perpendicular to the axis of lock fitting is 25°.
(y) The minimum angle of the external thread or lug non-bearing surface against separation with the plane perpendicular to the axis of the lock fitting is 0°.
(E) The minimum length of the male lock fitting is 7.5mm
(F) Nominal distance from the face of the fitting to the base of the lug is .20mm for Figures 3B and 3C.
(G) The maximum inside diameter of the external thread or the maximum outside diameter of the female lock fitting at base of lugs. The diameter should not be increased for a distance from the hub face of 5.5mm. For Figures 1, 2, 3a and 4 the dimension should be 6.73mm. For Figures 3b and 3c the dimension is 5.7.
(H) The thread root diameter of the male lock fitting is 8.0 +/- .10mm for Figures 1, 2, 3a, and 4
(J) Thread Crest diameter of the male lock fitting is 7.0 +/- .2mm for Figures 1, 2, 3a, and 4
(K) Maximum thread width of male lock fitting at root is 1.0mm for Figures 1, 2, 3a, and 4
(P) Minimum projection of nozzle from collar is 2.1 for Figures 1, 2, 3a, and 4
(Q) Minimum thread crest width of male lock fittings is .3mm for Figures 1, 2, 3a, and 4
(S) Thread Crest width or lug crest width of female lock fitting with lugs or external thread is .30 min. For Figures 1, 2, 3a, and 4 and .27 max. for Figures 3b and 3c.
(T) Maximum distance from tip of male lock fitting to the bottom of the first complete thread form of the internal thread. For Figures 1, 2, 3a, and 4 the crest width is .30mm min.
(V) Maximum chord length at the edge of lug in a plane at right angles to axis of fitting only, to be measured on a chord of a circle, the diameter which is J min (7.0mm). The chord length is 3.5mm for Figures 1, 2, 3a and 4 and 5.0 for Figures 3b and 3c.
(W) The minimum chord length at extremity of lug in a plane at right angles to axis of fitting only is 2.71mm for Figures 1, 2, 3a and 4
(X) The distance from axis of female lock fitting to extremity of lug
(2X) The outside diameter across the lugs or the external thread is 7.83mm +0/-.1 for Figures 1, 2, 3a, and 4 and 7.80mm for Figures 3b and 3c
(Y) The maximum width of base of lug or thread at base of female lock fitting to be measured at a point corresponding to an outside diameter equal to G (6.73max) is 1.2 for Figures 1, 2, 3a, and 4 and 1.30mm for Figures 3b and 3c.
Z) The width across the lugs at the external thread is 6.50 +0 – 0.1 for Figures 3b and 3c
Pitch – 2.5 is the nominal pitch of double start, right hand thread of female lock fitting – 5mm lead