DIN EN 1707-1997 Conical fittings with a 6 % (Luer) taper for syringes needles and certain other medical equipment - Lock fittings German version EN 1707 1996《注射器 套管针和其他医疗器械带6%锥度(吕.pdf

1、DEUTSCHE NORM January 1997 DIN EN 1707 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Lock fittings English version of DIN EN 1707 ICs 11.040.20 Supersedes DIN 13090-2, August 1984 edition. Descriptors: Conical fittings, medical equipment, syringes

2、, needles. Kegelverbindungen mit einem 6 % (Luer) Kegel fr Spritzen, Kanlen und bestimmte andere medizinische Gerte - Verriegelbare Kegelverbindungen European Standard EN 1707: 1996 has the status of a DIN Standard. A comma is used as the decimal marker. National foreword This standard has been prep

3、ared by CENTTC 205. The responsible German body involved in its preparation was the Normenausschu Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee). DIN 4763 and DIN 13098-1 are the standards corresponding to International Standards IS0 468-1 and IS0 7886, respec- tively, r

4、eferred to in clause 2 of the EN. Amendments DIN 13090-2, August 1984 edition, has been superseded by the specifications of EN 1707 Previous editions DIN 13090: 1940-09, 1941-07, 1974-06; DIN 13090-1: 1957-01; DIN 13090-2: 1984-08. Standards referred to (and not included in Normative references and

5、Annex ZA) DIN 4763 Grading of values for surface roughness parameters Disposable plastic syringes for general medical use - Dimensions, requirements and testing DIN 13098-1 EN comprises 16 pages. O No pari of this standard may be reproduced without the prior permission of DIN Deutsches Institut fr N

6、ormung e.V., Berlin. Eeuth Verlag GmbH, Berlin, has the exclusive right of sale for German Standards (DIN-Normen) Ref. No. DINEN 1707:1997-O1 Price group 10 Sales No. 11 1 O 06.97 COPYRIGHT DIN DEUTSCHES Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesCOPYRIGHT DIN DEUTSCH

7、ES Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesEUROPEAN STAN DAR D NORME EUROPENNE EUROPISCHE NORM EN 1707 November 1996 ICs 11.040.20 Descriptors: Conical fittings, medical equipment, syringes, needles. English version Conical fittings with a 6 % (Luer) taper for syri

8、nges, needles and certain other medical equipment Lock fittings Assemblages coniques 6% (Luer) des seringues et aiguilles et de certains autres appareils usage mdical - Assemblages verrouillage Verriegelbare Kegelverbindungen Kegelverbindungen mit einem 6 % (Luer) Kegel fr Spritzen, Kanlen und besti

9、mmte andere medizinische Gerte - This European Standard was approved by GEN on 1996-10-19. CEN members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date li

10、sts and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any GEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the resp

11、onsibility of a GEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norwa

12、y, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 1996. CEN - All rights of exploitation in any form and by any means res

13、erved worldwide for CEN national members. Ref. No. EN 1707:1996 E COPYRIGHT DIN DEUTSCHES Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesPage 2 EN 1707:1996 Contents Page Foreword 2 1 Scope 3 2 Normative references 3 3 Dimensions and tolerances 4 4 Requirements 4 5 Test m

14、ethods 6 Annex ZA (Informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives 16 Foreword This European Standard has been prepared by the Technical Committee CEN/TC 205 “Non-active medical devices“ the secretariat of which is held by BSI. Th

15、is European Standard applies to conical lock fittings with a 6 % (Luer) taper for use in medical equipment. EN 20594- 1 addresses general requirements for taper fittings. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorse

16、ment, at the latest by May 1997, and conflicting national standards shall be withdrawn at the latest by May 1997. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Direct

17、ive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard According to the CENKENELEC Internal Regulations, the national standards organizations of the follou ing countries are bound to implement this European Standard: Austria, Belgium, Denm

18、ark. Finland. France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Kiowa., Portugal, Spain, Sweden, Switzerland and the United Kingdom. COPYRIGHT DIN DEUTSCHES Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesPage 3 EN 1707:1996 1 Scope This European S

19、tandard 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 fittings made of rigid and of semi-rigid materials and include test m

20、ethods, but exclude provision for more flexible or elastomeric materials. NOTE 1. It 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 materiais. In contrast many plastics materials may be regarded

21、 as semi-rigid. NOTE 2. The Luer lock fitting was designed for use at pressures of the order of 30 kPa or lower. Its use in other applications may require consideration to establish its suitability. 2 Normative references This European Standard incorporates by dated or undated reference, provisions

22、from other publications. These normative references are cited at the appropriate place in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amend

23、ment or revision. For undated references the latest edition of the publication referred to applies. IS0 468 Surface roughness - Parameters, their values and general rules for specifying requirements EN 20594-1: 1993 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other med

24、ical equipment - Part 1 : General requirements (IS0 594-1 : 1986) IS0 7886-1 : 1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use COPYRIGHT DIN DEUTSCHES Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesPage 4 EN 1707:1996 3 Dimensions and tol

25、erances 3.1 Maie and female 6 % (Luer) conical fittings The dimensions and tolerances for the male and female fittings specified in EN 20594-1 apply to the relevant conical part of the fitting described in clause 4 of this European Standard. 3.2 Maie and female 6 % (Luer) conical lock fittings 3.2.1

26、 Rigid materials The dimensions of male and female lock fittings made of rigid materials shall be as shown in figures 1 to 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 fittings dimension

27、s accurately. Design and dimensions of fittings made of these materials may vary from those designated in figures 1 and 4 and given in table 1. However, the fittings shall meet the specified performance requirements when fitted to reference fittings as specified in 5.1. 4 Requirements 4.1 Gauging Wh

28、en tested with the appropriate gauge, the conical part of the lock fitting shall comply with EN 20594-1. 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 failing drop. 4.2.2 Air leakage When the fitting is tested in ac

29、cordance with 5.3, there shall be no signs of continued formation of air bubbles. Bubbles formed during the first 5 s shall be disregarded. COPYRIGHT DIN DEUTSCHES Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesPage 5 EN 1707:1996 4.3 Separation force When the fitting is

30、tested in accordance with 5.4, it shall remain attached to the reference fitting. 4.4 Unscrewing torque When the fitting is tested in accordance with 5.5, it shall remain attached to the reference fitting . 4.5 Ease of assembly When the fitting under test is mounted by hand on the appropriate refere

31、nce fitting in accordance with 5.6, the following criterion, as appropriate, shall be satisfied: a) rigid fittings: no resistance shall be observed until the taper of the fitting under test and the reference fitting fit together securely; b) semi-rigid fittings: a satisfactory fit shall be achieved

32、by applying an axial force not exceeding 20 N while applying a torque not exceeding 0,08 Nm. 4.6 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 fitting under test. 4.7 Stress cracking When the Fitting is

33、 tested in accordance with 5.8, there shall be no evidence of stress cracking of the fitting. NOTE. Materials used for fittings should be resistant to stress cracking in environments likely to be encountered in use (e.g. when in contact with solvents, surface active agents, etc.). COPYRIGHT DIN DEUT

34、SCHES Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesPage 6 EN 1707:1996 5 Test methods 5.1 General Tests shall be carried out using the appropriate reference fitting; reference fittings are shown in figures 5 to 8. The reference fittings shall be manufactured from harden

35、ed corrosion-resistant materials with a surface roughness value, $, not exceeding 0,8 pm (in accordance with IS0 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 EN 20594- 1 1993. 5.2 Liquid le

36、akage from fitting assembly under pressure 5.2.1 Connect the fitting to be tested to a reference fitting, the dimensions of which are in accordance with those shown in figures 5 or 7, as appropriate. Dry both fittings. Assemble the fittings by applying an axial force not exceeding 27,5 N while apply

37、ing 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 fitting assembly is dry. 5.2.3 With the axis of the lock fitting horizontal, seal the assembly outlet and bring the internal water pressure to an effective pressure of 300 kP

38、a to 330 kPa and maintain the pressure for 30 s. If 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 automa

39、tic 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 European Standard shall be the referee methods. 5.3.2 Male fiting 5.3.2.1 Connect the male fitting to a female reference fitting, the dimensions of wh

40、ich are in accordance with those shown in figure 5. Dry both fittings. Connect the male fitting to the female reference fitting by applying an axial force not exceeding 27,5 N while applying a torque not exceeding 0,12 Nm. COPYRIGHT DIN DEUTSCHES Institut Fur Normung E.V.- EnglishLicensed by Informa

41、tion Handling ServicesPage 7 EN 1707 : 1996 5.3.2.2 Connect the female reference fitting, via a leakproof joint of minimal volume, to a syringe which has passed the test for leakage past the piston during aspiration in accordance with IS0 7886-1. 5.3.2.3 Draw into the syringe, through the assembly,

42、a volume of recently boiled and cooled water exceeding 25 % of the graduated capacity of the syringe. Avoid wetting the outside of the assembly. 5.3.2.4 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 Occlu

43、de the device below the fitting assembly. With the nozzle of the syringe downwards, withdraw the plunger to nominal capacity and hold for 15 s. 5.3.3 Female fting Follow the same test procedure as specified in 5.3.2, but using a syringe with a male reference fitting, the dimensions of which are in a

44、ccordance with those shown in figure 7, to mate with the female fitting under test. 5.4 Separation force of fitting assembly 5.4.1 Connect the fitting to be tested to a reference fitting, the dimensions of which are in accordance with those shown in figure 6 or 8 as appropriate; follow the same asse

45、mbly procedure as specified in 5.2.1 for liquid leakage testing. 5.4.2 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 N/s and maintain it for not less than 10 s. Do not apply any force in other directions or any

46、inertial loading. 5.5 Unscrewing torque of fitting assembly 5.5.1 Follow the same assembly procedure as specified in 5.4.1. 5.5.2 Apply an unscrewing torque of (0,02 for semi-rigid fittings, apply an axial force not exceeding 20 N together with a torque not exceeding 0,08 Nm. COPYRIGHT DIN DEUTSCHES

47、 Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesPage 8 EN 1707:1996 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 8; apply a torque not less than 0,

48、15 Nm to the fitting under test and hold constant for 5 s. 5.8 Stress cracking 5.8.1 Connect the fitting to be tested to a reference fitting, the dimensions of which are in accordance with those shown in figures 5 and 7, as appropriate. Dry both fittings. Assemble the fittings by applying an axial f

49、orce not less than 273 N for 5 s while applying a torque not less than 0,12 Nm. 5.8.2 Allow the fittings to remain assembled for (48 f 1) h at (20 i- 5) OC. NOTE. The use of (27 f 5) “C is accepted as an alternative to (20 f 5) OC for tropical countries. COPYRIGHT DIN DEUTSCHES Institut Fur Normung E.V.- EnglishLicensed by Information Handling ServicesPage 9 EN 1707:1996 (Y Dimensions in millimetres Figures 1, 2, 3a and 4 25 + 0- 25 min. Angle of thread or lug bearing surface against separation with the plane perpendicular to the axis of lock fitting Angle of inter