STANDARD 594-2 ‘Second edition 1998-09-01 Te RRRER: HERTS 98 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings Assemblages coniques a 6 % (Luer) des seringues et aiguilles et de certains autres appareils 4 usage médical — Partie 2: Assemblages & verroullage Reference number 1S0 594-2:1996(E)ISO 594-2:1998(E) Contents Page 1 Scope wn 2 Normative references. 3 Dimensions and tolerances. © 1801998 ‘All ights reserved. Unless othorwise spacified, no pat of his publication may be reproduced or uiized in any form or by any means, electronic ‘or mechanical, including photocopying and microfim, without permission in wring ftom the publisher Intemational Organization for Standardization Case postale 98+ CH-1211 Ganéve 20 « Switzerand Infemet ieo@iso.ch Printed in Switzetand180 ISO 594-2:1998(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally cartied out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with 1SO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting Publication as an Intemational Standard requires approval by at least 75 % of the member bodies casting a vote, International Standard ISO 594-2 was prepared by Technical Committee ISO/TC 84, Medical devices for injections. This second edition cancels and replaces the first edition (ISO 594-2:1991), of which it constitutes a minor revision. It corresponds to European Standard EN 1707:1996, prepared by Technical Committee CEN/TC 205, Non-active medical devices. 180 594 consists of the following parts, under the general title Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment: — Part 1: General specifications — Part 2: Lock fittingsConical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings 1 Scope This part of ISO 594 specifies requirements for conical lock fittings with a 6 % (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use, e.g. transfusion equipment. The requirements apply to fitings made of rigid and of semi-rigid materials and include test methods, but exclude provision for more flexible or elastomeric materials. NOTE 1 is not practicable to define the characteristics of rigid or semi-rigid materials with precision, but glass and metal may be considered as typical rigid materials. In contrast many plastics materials may be regarded as semi-rigid. NOTE2 The Lucr lock fiting was designed for use at pressures of the order of 300 kPa or lower. Its use in other applications ‘may require consideration to establish its suitability. 2 Normative references ‘The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 594, For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, patties to agreements based on this part of ISO 594 are encouraged to investigate the possibilty of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid Intemational Standards. 180 468, Surface roughness — Parameters, their values and general rules for speciiying requirements. ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements. 1SO 7886-1, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use. 3 Dimensions and tolerances 3.1. Male and female 6 % (Luer) conical fittings. ‘The dimensions and tolerances for the male and female fitings specified in ISO 594-1 apply to the relevant conical part of the fiting described in clause 4 of this part of ISO 594. 3.2. Male and female 6 % (Luer) conical lock fittings 3.2.1. Rigid materials The dimensions of male and female lock fitings made of rigid materials shall be as shown in Figures 1 10 4 and as given in Table 1.3.2.2 Semi-rigid materials For fittings made using semi-rigid materials, because of their nature it is not possible to specify the fitings dimensions accurately. Design and dimensions of fitings made of these materials may vary from those designated in Figures 1 and 4 and given in Table 1. However, the fitings shall meet the specified performance requirements when fited to reference fitings as specified in 5.1. 1) Double-star, right-hand thread of 2,5 mm pitch, Figure 1 — Male 6 % (Luer) conical lock fitting with permanently connected internally threaded collar NOTE For other dimensions, see Figure 1. Figure 2— Male 6 % (Luer) conical lock fitting with rotatable internally threaded collara) Variant A b) Variant B ) Variant © NOTE 1 Ita female 6 % (Luer) conical lock fitting has lugs in a plane inclined to the axis offing, the lugs should form a part ofthe thread form shown in Figure 4. In this case, "V' does not apply. NOTE2 Variants B and C are intended to be used for the design of rigid fitings only NOTE 3. To ensure compatbilty with existing rigid fitings, a maximum K = 0,8 mm is preferred, Figure 3 — Female 6 % (Luer) conical lock fittings with lugs in a plane at right angles to axis of fi1) Pitch, NOTE For other dimensions, see Figure 3. Figure 4 — Female 6 % (Luer) lock conical fitting with external threadTable 1 — Dimensions of 6 % (Luer) rigid conical lock fittings Dimensions in milimetres ‘Symbol Designation Dimensions Figures 1.2, | Figures 3b) 3a) and ‘and 3¢) @ [Angle of thread or tug bearing surface against separation with the] ao.5" 250+ plane perpendicular to the axis of lock fting o a B [Minimum angle of internal thread non-bearing surface against| 55. _ separation withthe plane perpendicular tothe axis of lock fiting 7 [Minimum angle of extemal thread or lug non-bearing surface against ie o | separation withthe plane perpendicular tothe axis ofthe lock fiting E | Minimum length of male tock fing 78 = Nominal distance from the face ofthe fiting tothe base ofthe lug = 020 | Maximum outside diameter of female lock fiting at base of lugs or maximum inside diamotor of extemal tread, This diameter shall notbe| 6,73 87 increased for a distance from the hub face of 5,5 mm | | Poot diameter of the thread of male lock iting 8.0401 = J [Crest ciameter ofthe thread of male lock fiting 7.0402 = [Maximum thread wicth of mate lock iting at root 1 = P| Maimum projection of nozzle from collar 24 = 2 [Minimum tread crest width of male lock fitings 08 = ‘S| Lug crest width or thread crest with of female lock fiting with kage or| - max. extemal thread ca oa T [Maximum eistance trom tp of male lock fing to the botiom of fst] 5 _ ‘Complete thread form o the intemal thread | Maximum chord length at base of lug in plane at right anglos to axis of fiting only, to be measured on a chord of a circle the diameter of| 9,5 50 which is Jin. (7,0 mm) W_ [Minimum chord tength at extremity of ug ina plane at right angles to] 5 74 _ axis of fiting only (W shall not be greater than V) " X___[ Distance trom axis of female lock fiting to extremity of lug = = 2X | Outside diameter across the lugs or external thread 788.2, | 780.9, Y | Maximum width of base of lug (axa) or thread at base, of female lock iting to be measured ata point cortesponding to an outside diameter| 1,2 1,90 equal to G (6,73 max) Z| Width across the tugs at external thread 7 6502, Pitch [Nominal pitch of double-sta, right-hand thread of female lock fing] 9.5 _ -Smmlead :4 Requirements 44 Gauging ‘When tested with the appropriate gauge, the conical part ofthe lock fiting shall comply with ISO 594-1 4.2 Leakage 4.2.1 Liquid leakage ‘When the fitting is tested in accordance with 5.2, there shall be no leakage sufficient to form a falling drop, 422 Air leakage ‘When the fitting is tested in accordance with 5.3, there shall be no signs of continued formation of air bubbles. Bubbles formed during the first 5 s shall be disregarded. 4.3 Separation force When the fiting s tested in accordance with 5.4, it shall remain attached to the reference fiting. 4.4. Unscrewing torque When the fiting is tested in accordance with 5.5, it shall remain attached to the reference fitting. 4.5 Ease of assembly When the fiting under test is mounted by hand on the appropriate reference fiting in accordance with 5.6, the following criterion, as appropriate, shall be satisfied: a) rigid fitings: no resistance shall be observed until the taper of the fiting under test and the reference fiting fit together securely; b) semi-rigid fitings: a satisfactory fit shall be achieved by applying an axial force not exceeding 20 N while applying a torque not exceeding 0,08 Nm. 46 Resistance to overriding When the fitting is tested in accordance with 5.7, the reference fitting shall not override the threads or lugs of the fting under test. 47 Stress cracking When the fiting is tested in accordance with 5.8, there shall be no evidence of stress cracking of the fiting. NOTE Materials used for fitings should be resistant to stress cracking in environments likely to be encountered in use (e.g. when in contact with solvents, surface-active agents, oc.). 5 Test methods 5.1 General Tests shall be carried out using the appropriate reference fiting; reference fitings are shown in Figures § to 8. The reference fitings shall be manufactured from hardened corrosion-resistant materials with a surface roughness value, a, not exceeding 0,8 hsm (in accordance with ISO 468) on critical surfaces. The dimensions of the conical part of these reference fittings shall be in accordance with those specified in Figures 4 and 5 of ISO 594-1986.5.2. Liquid leakage from fitting assembly under pressure 5.2.1 Connect the fiting to be tested to a reference fiting, the dimensions of which are in accordance with those shown in Figure § of Figure 7, as appropriate. Dry both fitings. Assemble the fitings by applying an axial force not exceeding 27,5 N while applying a torque not exceeding 0,12 Nm. 5.2.2 Introduce water into the assembly and expel the air. Ensure that the outside of the fiting assembly is dry 5.2.3 With the axis of the lock fiting horizontal, seal the assembly outlet and bring the internal water pressure to an effective pressure of 300 kPa to 330 kPa and maintain the pressure for 30 s. It the intended use is on a device employing higher pressure, then this shall be taken into consideration during testing. 5.3. Air leakage into fitting assembly during aspiration 5.3.1 General Other validated test methods (e.g. methods involving automatic testing) may be used if good correlation is shown with the reference test given in 5.3.2 or 5.3.3. In cases of dispute, the methods given in this part of SO 594 shall be the referee methods. 5.3.2 Male fitting 5.3.2.1 Connect the male fiting to a female reference fiting, the dimensions of which are in accordance with those shown in Figure 5. Dry both fittings. Connect the male fiting to the female reference fiting by applying an axial force not exceeding 27,5 N while applying a torque not exceeding 0,12 Nm. 5.3.2.2 Connect the female reference fiting, via a leakproof joint of minimal volume, to a syringe which has passed the test in accordance with ISO 7886-1 for leakage past the piston during aspiration. 5.3.2.3 Draw into the syringe, through the assembly, a volume of recently boiled and cooled water exceeding 25 % of the graduated capacity of the syringe. Avoid wetting the outside of the assembly. 5.3.24 Expel the air except for a small residual air bubble and adjust the volume of water in the syringe to 25 % of the graduated capacity. 5.3.2.5 Ocolude the device below the fting assembly. With the nozzle of the syringe pointing downwards, withdraw the plunger to nominal capacity and hold for 15s. 5.3.3 Female fitting Follow the same test procedure as specified in 5.3.2, but using a syringe with a male reference fitting, the dimensions cof which are in accordance with those shown in Figure 7, to mate with the female fiting under test. 5.4 Separation force of fitting assembly 5.4.1 Connect the fiting to be tested to a reference fiting, the dimensions of which are in accordance with those shown in Figure 6 or Figure 8 as appropriate; folow the same assembly procedure as specified in 5.2.1 for liquid leakage testing 5.42. Apply an axial force progressively up to 35 N in a direction away from the test fixture. Apply the force at a rate of ‘approximately 10 Nis and maintain it for not less than 10s. Do not apply any force in other directions or any inertial loading5.5 Unscrewing torque of fitting assembly 5.5.1 Follow the same assembly procedure as specified in 5.4.1. 552 Apply an unscrewing torque of (002, fpqe] Nm to he assembly and maintain for not ess than 10. Do not apply any force in other directions or any inertiat loading. 5.6 Ease of assembly Mount by hand the fiting under test on the male or female reference fitting (see Figures 5 and 7) as appropriate. For rigid fitings, assemble the fittings securely; for semi-rigid fitings, apply an axial force not exceeding 20 N together with ‘a torque not exceeding 0,08 N-m. 5.7 Resistance to overriding Follow the same procedure as specified in 5.2.1 for liquid leakage testing, but using the appropriate reference fitting shown in Figure 6 or Figure 8; apply a torque not less than 0,15 N-m to the fitting under test and hold constant for 5 s. 5.8 Stress cracking 5.8.1 Connect the fiting to be tested to a reference fitting, the dimensions of which are in accordance with those shown in Figures § and 7, as appropriate. Dry both fittings. Assemble the fitings by applying an axial force not less than 27,5 N for 5 s while applying a torque not less than 0,12 Nem. 5.8.2. Allow the fittings to remain assembled for (48 + 1) h at (20) °C. NOTE The use of (27 +5) °Cis accepted as an altomalive to (20 + 5) °C for tropical countries.Dimensions in milimetres, 0.18 mm and 0,2 mm (unless otherwise spectied), ing male 6 % (Luer) lock fittings for leakage, stress cracking (see 5.2, 5.3, 5.5, 5.6 and 5.8) 9 for testi unscrewing torque and NOTE All outside edges of ug or thread form shall hiDimensions in milimetres Pa OS Boas 02 250 NOTE All outside edges of lug or thread form shall have a radius between 0,15 mm and 0,2 mm (unless otherwise specified). Figure 6 — Female reference conical fitting for testing male 6 % (Luer) lock fittings for separation force and resistance to overriding (see 5.4 and 5.7) 10Dimensions in millimetres 1) Maximum distance trom tip of male lock fitting to the bottom of frst complete thread form of the internal thread (see Tin Table 1). 2) Double-stan, right-hand thread of 2,5 mm pitch Figure 7 — Male reference conical fitting for testing female 6 % (Luer) lock fittings for leakage, ease of assembly, unscrewing torque and stress cracking (see 5.2, 5.3, 5.5, 5.6 and 5.8) Dimensions in millimetres ty et | GN | To Ke J 5 | StS Sy N Lida. YX 1) Maximum distance from tip of male lock fiting o the first complete thread form of the intemal thread (see Tin Table 1). 2) Double-star, right-hand thread of 2,5 mm pitch, Figure 8 — Male reference conical fitting for testing female 6 % (Luer) lock fittings for separation force ‘and resistance to overriding (see 5.4 and 5.7) WICS 11,040.20 Descriptors: medical equipment, syringes, hypodermic neodt dimensions, tests, pressure tosis fitings, conical clamping connections, locking devices, specications, Price based on 11 pages