EN 20594-1-1993 en Conical Fittings with a 6% (Luer) Taper for Syringes Needles and Certain Other Medical Equipment - Part 1 General Requirements (Incorporates Amendment A1 1997)《注.pdf

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1、- STD-BSI BS EN 20594-1-ENGL 1994 W Lb24bb9 b91757 b24 W Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1. General requirements * * m The European Standard EN 205941 : 1993, with the incorporation of its amendment Al : 1997 has the status of a

2、 British Sandard 5s EN i05941 : 1994 SO 594-1 : 1986 ncorpomting imendmmt No. 1 to !S 3930 : Pa#rt 1 : 1987 renumbers BS as ind Amendme7lt No. 1 lS EN 20594-1 i 1994) !I BS EN 20594-1 : 1994 ICs 11.040.20 I NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 20594-1 : 1994 I

3、ssue 2, March 1998 Contents National foreword Committees responsible I Foreword Specification O. Introduction 1. Scope and field of application 2. References 3. Dimensions 4. Requirements 5. Test methods National foreword Page Page Inside front cover Annex Back cover Liquid leakage 7 ZA Clauses of t

4、his European Standard addressing ii essential requirements or other provisions of EU Directives 8 1 1 Table 1 1 Dimensions of 6 % (Luer) conical fittings 3 3 Figures 1. Typical 6 % (Luer) conical fittings 2 2. Typical assembly of 6 % (Luer) conical fittings 2 3. Gauges for testing 6 % (Luer) conical

5、 fittings 5 4. Reference steel female conical fitting 6 5. Reference steel male conical fitting 6 This Part of BS 3930 has been prepared under the direction of the Health Care Standards Committee and is the English language version of EN 20594-1 : 1993 Conical fittings with a 6 % (Luer) taper for sy

6、ringes, needles and other medical equipment - Part 1: General requirements, including amendment Al. It is identical with IS0 594-1 : 1986, published by Technical Committee 84 Syringes for medical use and needles for injection of the International Organization for Standardization (ISO). BS 3930 Speci

7、fication for conical fittings with 6 per cent (Luer) taper for hypodermic and other surgical equipment was first published in 1965 and specified requirements for Luer slip fittings made of rigid materials, e.g. metal, glass. This standard is the first Part of a two-part revision of BS 3930 : 1965 an

8、d specifies requirements for Luer slip fittings made of rigid and semi-rigid materials. It supersedes BS 3930 : 1965, which is withdrawn. The second Part of this revision will specify requirements for Luer lock fittings (which were not covered in the 1965 edition), and will implement IS0 594/2. This

9、 Part of BS 3930 also supersedes the requirements for Luer slip fittings made of semi-rigid materials given in BS 5081 : 1976 Sterile hypodermic syringes and needles for single use. BS 5081 is itself being revised in two Parts so as to take account of IS0 7864 Sterile hypodermic needles for single u

10、se and IS0 7886 Sterile hypodermic syringes for single use and to delete the dimensional requirements for Luer fittiiigs. In 1993 the European Committee for Standardization (CEN) accepted IS0 594-1 : 1986 as European Standard EN 20594-1 : 1993. As a consequence of implementing the European Standard

11、this British Standard is renumbered as BS EN 20594-1 and any reference to BS 3930 : Part 1 should be read as a reference to BS EN 20594-1. Terminology and conventions. The text of the international standard has been approved as suitable for publication as a British Standard without deviation. Some t

12、erminology and certain conventions are not identical with those used in British Standards; attention is drawn especially to the following. The comma has been used as a decimal marker. In British Standards it is current practice to use a full point on the baseline as the decimal marker. Wherever the

13、words this part of IS0 594 appear, they should be read as this Part of BS 3930. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Co

14、rrespondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. Additional information. With reference to the table of dimensions, dimension F is not intended to proscribe fittings which are only tapered to the depth of socket equivalent to the maximum length of engageme

15、nt and which are not tapered for the remainder of the minimum depth of the fitting. The IS0 text will be amended to take account of this when the standard is revised. Compliance with a British Standard does not of itself confer immunity from legal obligations. I *in preparation. Q BSI 1998 Issue 1,

16、March 1998 Page Issue Page Front cover 2 1 to 6 inside front cover 2 7 a 1 8 b blank Inside back cover EN title page 1 Back cover 11 1 BS EN 20594-1 : 1994 Issue Original Original original 2 2 Summary of pages The following table identifies the current issue of each page. Issue 1 indicates that a pa

17、ge has been introduced for the first time by amendment. Subsequent issue numbers indicate an updated page. Vertical sidelining on replacement pages indicates the most recent changes (amendment, addition, deletion). O BSI 1998 a STD-BSI BS EN 20594-1-ENGL 199Li lb24bb9 b91959 YT7 STD-BSI BS EN 20594-

18、L-ENGL 1994 m Lb24bbS Ob9L9b0 119 EN 205941 August 1993 + Al November 1997 UM: 615.473.36 Descriptors: Medical equipment, syringes, surgical needles, perfusion equipment, blood transfusion equipment, joining, fittings, specifications, dimensions, tests English version Conical fiUings with a 6% (Luer

19、) taper for syringes, needles and certain other medical equipment - Part 1: General requll-ements (includuig amendment Al : 1997) (IS0 594-1 : 1986) Assemblages coniques 6 % (Luer) des seringues et aiguilles et de certains autres appareiis usage mdical - medizinische Gerate - Partie 1: Spcifications

20、 gnraies (inclut iamendement Al : 1997) (Is0 59Q-1: 1986) Kegelverbindungen mit einem 6 % (Luer) Kegel fur Spritzen, Kanlen und bestimmte andere Teil 1: Allgemeine Anforderungen (enthalt nderung Al : 1997) (IS0 5W1: 1986) This European Standard was approved by CEN on 19934812. CEN members are bound

21、to comply with the CEN/CENELEC internai Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibiiographical references concerning such national standards may be obtained on application to the Cent

22、ral Secretariat or to any GEN member. This European Standard exists in three officiai versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notifed to the Central Secretariat has the same status as t

23、he officiai versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Conunittee for Standardization Comit Eur

24、open de Normaisation Europisches Komitee fur Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 1993 Copyright reserved to CEN nieinbers Ref. No. EN 205941 : 1993 + Al : 1997 E EN 20594-1 : 1993 Issue 1, March 1998 Foreword in 1989, Is0 594-1 : 1986 Cmicalflttings with a 6 % (Luer) t

25、aper for syrnges, 728ed(es and certain OW medical equ.ilmzent - Pa? 1: ceneral requiremats was submithi to the CEN primary Quesonnajre procedure. Foilowing the positive result of the CEN/CS Proposai, IS0 594-1 : 1986 was submitted to the Formai Vote. The result of the Fonnal Vote was positive. This

26、European Standard shaii be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 1994, and confiicting nationai standards shall be withdrawn at the latect by February 1994. According to the CEN/CENELEC Intema Regulations, the

27、 following countries are bound to implement this European Stanard Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Foreword to amendment Al This amendment EN 20594-1 : 1993A1:

28、1997 to EN 20594-1 : 1993 has been prepared by Technical Committee CENAC 206, Non-acve medical devices, the secretariai of which is held by BSI. This amendment to the European Standar EN 20594-1 : 1993 shall be given the status of a national standard, either by publication of an identical text or by

29、 endorsement, at the latest by May 1998, and corlicting national stanards shall be withdrawn at the latest by May 1998. This amendment consists of annex ZA to EN 20694-1 : 1993. For relationship with EU DWve(s), see informative annex ZA, which is an integral part of this standard. According to CEN/C

30、ENELEC Intemal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Fnland, France, Gennany, Greece, Iceland, ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. ii STD

31、-BSI BS EN 20574-1-ENGL 1994 Lb24bbf Obf1b2 T71 = BS 3930 : Part 1 : 1987 British Standard Conical fittings with a 6 % (Luer) taper for syringes, needles and other medical equipment Part 1. Specification for general requirements O Introduction In this revision of ISO/R 594 first published in 1967, t

32、he oppor- tunity has been taken to incorporate test methods for gauging and performance. It should be noted that the annex does not form an integral part of the standard. IS0 W/2 deals with lock fittings. 1 Scope and field of application This part of IS0 594 specifies requirements for conical fittin

33、gs 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 and perfor- - - = e - II E - * *

34、III mance. It excludes provision for more flexible or elastomeric materials. Figure 1 illustrates typical male 6 % (Luer) conical fitting (“male fitting“) and female 6 % (Luer) conical fitting I“femalefitting“). NOTE - It is not practicable to Mine the charactefistics of rigid or semi-rig materials

35、with precioion, but glass and metal may be con- sidered as typical rigid materials. By contrast, many plastic materials may bei regarded as semi-rigid although the wall thickness is an impor- tant factor influencing the rigidity of a component. 2 References IS0 59412, Comcal fittings with a 6 % (Lue

36、ri taper for syringes, needles and certain other medical equipment - Pari 2: Lock fittings. 1 ) IS0 7886, Sterile hypodermic syringes for single use. 3 Dimensions The dimensions of male and female conical fittings shall be as given in the table and as shown in figure 1. A typical assembly of 6 % (Lu

37、er) conical fittings is shown in figure 2. 1) At present at the stage of draft. 1 The dimensions of the assembly shall be as given in the table. Dimensions in millimetres R 0.5 max . Male 6 % (Luerl conical fitting (“male fitting“) chamfer Female 6 % iLuer) conical fitting (“femal efitting“b Figure

38、1 - Typical % (Luer) conical fittings see the corresponding values in the table) Figure 2 - Typical assembly of 6 % (Luer) conical fittings (see the corresponding values in the tabiel * * m STDVBSI BS EN 2059LI-L-ENGL 1994 lb2Ybb9 Ub7L7b4 b4 BS 3930 : Part 1 : 1987 I Reference Basic dimensions Other

39、 dimensions min. I(Mx. min. max, E F L M N R“ mai Table - Dimensions of 6 % (Luert conical fittings I imensionstmm) 1 Ouignition rigid 4.270 4,315 7.500 Minimum diameter of the end of the male conical fitting (reference diameter) Maximum diameter at the end d the male conical fitting Minimum diamete

40、r at the opening of the female conical fitting Maximum diameter at the opening qf the female conical fitting Minimum length of the male conical fitting Minimum depth of the female conical fitting Minimum length of engagement Tolerance for length of engagement of the female conical fitting Tolerance

41、for length of engagement of the male conical fitting Radius of curvature 4.665 0.750 1.083 0.5 * Dimensions L, M and N are derived from the basic dimensions. Or equivalent entry chamfer without any sharp corners. 4 Requirements 4.1 Gauging When tested in accordance with 5.1, the conical fitting shal

42、l satisfy the requirements specified in 4.1.1 and 4.1.2. 4.1.1 The small end of the male conical fitting shall lie beriinreen the nnro limit pianes oftbe gauge and the iargerend ofthe tapered portion shall exterd beyond the datum piane of the gauge. Rocking shall not be evident between the gauge and

43、 the fitting made of rigid11 material undergoing test. 4.1.2 The plane of the maximum diameter at the opening of the female conical fming shall lie between the two Iimit planes of the gauge. Rocking shall not be evident between the gauge and the fitting made of rigid 1) material undergoing test. 4.2

44、 Liquid leakage Th WLC under the test conditions described in 5.2. shall be no leakage sufficient to form a falling drop of semi-rigid material 3,925 4,027 4.270 4,315 4.050 0,750 0.5 The axis of the conical fitting under test shall be horizontal. 4.3 Air leakage Continued formation of air bubbles s

45、hall not be evident under the test conditions described in 5.3. Bubbles formed during the first 5 s shall be ignored. 4.4 Separation force The conical fimng under test shall remain attached to the test fixture, under the test conditions described in 5.4. 4.5 Stress cracking There shall be rio eviden

46、ce of stress cracking of the conical fit- ting, under the test conditions described in 5.5. NOTE - Materials used for conical fittings should be resistant to stress cracking in environments likely to be encountered in use (for example when in contact with aicohok). II The test for freedom from rocki

47、ng may be found useful for evaluating semi-rigid fittings. 3 BS 3930 : Part 1 : 1987 5 Test methods 5.3.1.2 Connect the reference female fitting by means of a leakproof joint of minimal volume to a syringe, the latter having 5.1 Gauging test previously passed the test for leakage past the piston dur

48、ing aspiration, in accordance with IS0 7886. The procedure shall be carried out as specified in 5.1.1 to 5.1.4. 5.3.1.3 Draw into the syringe, through the device and the 5.1.1 Carry out the test using steel gauges as illustrated in female reference fitting, a volume of recently boiled and cooled fig

49、ure 3. water exceeding 25 % of the graduated capacity of the syringe. 5.1.2 Carry out the test at a temperature of (20 f 5) OC. 5.3.1.4 Expel the air except for a small residual air bubble. 5.1.3 to testing* condition products made from 5.3.1.5 Adjust th of water in the syringe to 25 % of hygroscopic mterials at (20 f 5) OC and (50 f 10) % relative humidq for not less than 24 h. Conditioning is not required for the graduated capacity. products made from non-hygroscopic materials. 5.1.4 Apply the gauge