BS-EN-20594-1-1994 ISO-594-1-1986.pdf
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1、BRITISH STANDARD BS EN 20594-1:1994 ISO 594-1: 1986 Incorporating Amendment No. 1 to BS 3930-1:1987 (renumbers BS as BS EN 20594-1:1994) and Amendment No. 1 to BS EN 20594-1: 1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requi
2、rements The European Standard EN 20594-1:1993, with the incorporation of its amendment A1:1997 has the status of a British Standard ICS 11.040.20 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 01:21:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 20594-1:1994 This British Standard, havin
3、g been prepared under the direction of the Health Care Standards Committee, was published under the authority of the Board of BSI and comes into effect on 30 January 1987 BSI 04-1999 ISBN 0 580 15585 4 Committees responsible for this British Standard The preparation of this British Standard was entr
4、usted by the Health Care Standards Committee (HCC/-) to Technical Committee HCC/2, upon which the following bodies were represented: Association of Clinical Pathologists British Dental Trade Association British Diabetic Association British Surgical Trades Association Incorporated Department of Healt
5、h and Social Security Disposable Hypodermic and Allied Equipment Manufacturers Association Glass Manufacturers Federation Medical Sterile Products Association Pharmaceutical Society of Great Britain Coopted members Amendments issued since publication Amd. No.DateComments 8072February 1994 Implements
6、 EN 20594-1 as a British Standard 9881March 1998Indicated by a sideline in the margin Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 01:21:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 20594-1:1994 BSI 04-1999i Contents Page Committees responsibleInside front cover National forewordii
7、Foreword2 0Introduction3 1Scope and field of application3 2References3 3Dimensions3 4Requirements3 5Test methods5 Annex Liquid leakage9 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives10 Figure 1 Typical 6 % (Luer) conica
8、l fittings4 Figure 2 Typical assembly of 6 % (Luer) conical fittings4 Figure 3 Gauges for testing 6 % (Luer) conical fittings7 Figure 4 Reference steel female conical fitting8 Figure 5 Reference steel male conical fitting8 Table Dimensions of 6 % (Luer) conical fittings5 Table ZA.1 Correspondence be
9、tween this European Standard and EU Directives10 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 01:21:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 20594-1:1994 ii BSI 04-1999 National foreword This Part of BS 3930 has been prepared under the d
10、irection 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 syringes, needles and other medical equipment Part 1: General requirements”, including amendment A1. It is identical with ISO 594-1:1986, published by
11、Technical Committee 84 “Syringes for medical use and needles for injection” of the International Organization for Standardization (ISO). BS 3930 “Specification for conical fittings with 6 per cent (Luer) taper for hypodermic and other surgical equipment” was first published in 1965 and specified req
12、uirements 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 and specifies requirements for Luer slip fittings made of rigid and semi-rigid materials. It supersedes BS 3930:1965, which is withdrawn. The second Par
13、t of this revision will specify requirements for Luer lock fittings (which were not covered in the 1965 edition), and will implement ISO 594/2. This 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
14、 and needles for single use”. BS 5081 is itself being revised in two Parts so as to take account of ISO 7864 “Sterile hypodermic needles for single use” and ISO 7886 “Sterile hypodermic syringes for single use” and to delete the dimensional requirements for Luer fittings. In 1993 the European Commit
15、tee for Standardization (CEN) accepted ISO 594-1:1986 as European Standard EN 20594-1:1993. As a consequence of implementing the European Standard this British Standard is renumbered as BS EN 20594-1 and any reference to BS 3930-1 should be read as a reference to BS EN 20594-1. Terminology and conve
16、ntions. The text of the international standard has been approved as suitable for publication as a British Standard without deviation. Some terminology and certain conventions are not identical with those used in British Standards; attention is drawn especially to the following. The comma has been us
17、ed 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 words “this part of ISO 594” appear, they should be read as “this Part of BS 3930”. Cross-references The British Standards which implement international or Euro
18、pean publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. Additional information. With reference to the table of dime
19、nsions, dimension F is not intended to proscribe fittings which are only tapered to the depth of socket equivalent to the maximum length of engagement and which are not tapered for the remainder of the minimum depth of the fitting. The ISO text will be amended to take account of this when the standa
20、rd is revised. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This docu
21、ment comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 10, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside fron
22、t cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 01:21:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORME EN 20594-1 August 1993 + A1 November 1997 UDC 615.473.36 Descriptors: Medical equipment, syringes, surgical needles, perfusion equipm
23、ent, blood transfusion equipment, joining, fittings, specifications, dimensions, tests English version Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements (including amendment A1:1997) (ISO 594-1:1986) Assemblages coniques 6
24、 % (Luer) des seringues et aiguilles et de certains autres appareils usage mdical Partie 1: Spcifications gnrales (inclut lamendement A1:1997) (ISO 594-1:1986) Kegelverbindungen mit einem 6 % (Luer) Kegel fr Spritzen, Kanlen und bestimmte andere medizinische Gerte Teil 1: Allgemeine Anforderungen (e
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