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1、BRITISH STANDARD BS 3522:1962 Specification for Hypodermic surgical mounted needles (Luer fitting) Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3522:1962 This British Standard, having been approved by the Surgical Instruments and Medic
2、al Appliances Industry Standards Committee and endorsed by the Chairman of the Chemical Divisional Council, was published under the authority of the General Council on 2 July 1962 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference SGC/2 Draft for commen
3、t AB(SGC) 2468 ISBN 0 580 35575 6 Co-operating organizations The Surgical Instruments and Medical Appliances Industry Standards Committee, under whose supervision this British Standard was prepared, consists of representatives from the following Government departments and professional and industrial
4、 organizations: Admiralty* Air Ministry* Association of Hospital Matrons* British Dental Association* British Medical Association* British Paediatric Association British Surgical Trades Association, Inc.* Federation of British Rubber and Allied Manufacturers Institute of British Surgical Technicians
5、 Medical Defence Union* Medical and Dental Defence Union of Scotland Medical Protection Society Ministry of Agriculture, Fisheries and Food Ministry of Health* Queens Institute of District Nursing Royal College of Midwives Royal College of Nursing* Royal College of Obstetricians and Gynaecologists R
6、oyal College of Physicians of London Royal College of Surgeons of Edinburgh Royal College of Surgeons of England* Royal College of Veterinary Surgeons Royal Faculty of Physicians and Surgeons of Glasgow War Office* The Government departments and professional and industrial organizations marked with
7、an asterisk in the above list, together with the following, were directly represented on the committee entrusted with the preparation of this British Standard. Association of Clinical Pathologists British Dental Manufacturers Association British Diabetic Association British Iron and Steel Federation
8、 British Veterinary Association Faculty of Anaesthetists Glass Manufacturers Federation High Commission of India National Federation of Hospital Officers Surgical Needle Manufacturers Association Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed
9、 Nov 29 03:27:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3522:1962 BSI 10-1999i Contents Page Co-operating organizationsInside front cover Forewordii 1Scope1 2Definitions1 3Size range and dimensions1 4Needle point1 5Bore of the needle1 6Materials1 7Test requirements for hypodermic needles1 8Ne
10、edle hub3 9Cleaning wires4 10Marking4 Figure 1 Needle point with long bevel5 Figure 2 Needle point with short bevel5 Figure 3 Method of marking of packages of needles to indicate the angle of bevel5 Table 1 Size range of hypodermic needles2 Table 2 Stiffness test3 Table 3 Elasticity test3 Table 4 Re
11、verse bend test3 Table 5 Loading test for union of blade and hub4 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3522:1962 ii BSI 10-1999 Foreword This standard makes reference to the following British Standards: BS 970, Wrought steels.
12、En series. BS 2045, Preferred numbers. BS . . . ., Conical fitting with 6 per cent taper (Luer) for hypodermic and other surgical equipment1). This British Standard forms one of a series of specifications for hypodermic equipment, the preparation of which was authorized by the Surgical Instruments a
13、nd Medical Appliances Industry Standards Committee. In this standard provision is made for a range of stainless steel hypodermic needles having the Luer conical fitting and suitable for general requirements in medical and surgical practice. The Luer conical fitting is specified in uniformity with ot
14、her British Standards for hypodermic equipment. After careful consideration of other types of conical fittings, the technical committee responsible for the preparation of this specification is unanimous in its opinion that the Luer conical fitting be recommended for general adoption as the type of c
15、onical fitting to be used for hypodermic equipment in the United Kingdom on the grounds of the greater strength of the syringe nozzle and the better grip attained between the syringe nozzle and the needle mount as compared with other fittings. The dimensions specified for the conical socket of the h
16、ub of the needle are specified to fit the syringe tip (Luer conical fitting) specified in British Standards BS 1263 and BS 1619 and in the American Federal Specification GG-S-921a, “Syringes; all-glass Luer”. Pending publication of a new British Standard for the Luer conical fitting, reference may b
17、e made to BS 1263:1946 for details on the Luer fitting. A feature of the standard which, it is believed, is of particular interest is the system of identification of needles. No generally accepted method of designating the size of hypodermic needles outside certain established ranges has been widely
18、 used in the past. In some cases, both purchaser and manufacturer have been forced to resort to cumbersome descriptions to avoid misinterpretation. To satisfy the existing demand for a short, flexible, explicit and standard form of identification of each size of needle, it is hoped that the method o
19、f size designation described in this standard will be generally adopted to ensure the maximum advantages to manufacturers, purchasers and users of hypodermic needles. The sizes, diameters and lengths of the hypodermic needles specified are in accordance with the proposals concerning hypodermic equip
20、ment considered by Technical Committee TC84 of the International Organization for Standardization (ISO) at the meeting held in Paris in November, 1961. Other standards for hypodermic equipment include: BS 1263, Hypodermic syringes for general medical use (Luer fitting) (under revision). BS 1619, Hyp
21、odermic syringes for insulin injection (Luer fitting) (under revision). BS 2983, Hypodermic dental needles. BS . . . ., Conical fitting with 6 per cent taper (Luer) for hypodermic and other surgical equipment (in course of preparation). BS . . . ., Fine dosage hypodermic syringes (tuberculin type) (
22、in course of preparation). NOTEWhere metric equivalents are stated the figures in British units are to be regarded as the standard. The metric conversions are approximate. More accurate conversions should be based on the tables in BS 350, “Conversion factors and tables”, or in BS 2856, “Precise conv
23、ersion of inch and metric sizes on engineering drawings”. 1) In course of preparation. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3522:1962 BSI 10-1999iii A British Standard does not purport to include all the necessary provisions of
24、 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 document comprises a front cover, an inside front cover, pages i to iv, pages 1 to 5 and a back c
25、over. 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 front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Co
26、py: sheffieldun sheffieldun, na, Wed Nov 29 03:27:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3522:1962 BSI 10-19991 1 Scope This British Standard specifies requirements for a range of sizes of stainless steel hypodermic needles from 26 gauge (0.018 in, 0.45 mm) to 18 gauge (0.049 in, 1.24 mm)
27、mounted with Luer conical socket (6 per cent taper) and also describes a method of size designation. Points for the specified range of hypodermic needles are specified alternatively as long with a bevel of 12 degrees nominal or short with a bevel of 18 degrees nominal. The specified range of sizes i
28、s intended for general use in medicine. 2 Definitions Terms relating to hypodermic needles are defined as follows: 2.1 length of needle the exposed length of the needle as measured from the tip of the point to the joint with the hub 2.2 point (also known as the bevel) the bevelled portion of the end
29、 of the needle tube 2.3 angle of point the angle of the bevel to the linear axis of the needle as illustrated in Figure 1 and Figure 2 2.4 hub (also known as the mount) the component carrying the needle tube and having a conical socket to fit the conical tip of the syringe 2.5 bore (also known as th
30、e lumen) the internal diameter of the needle tubing 3 Size range and dimensions The size range, size designation and dimensions of hypodermic needles shall be in accordance with Table 1. The hypodermic needles shall be described by the following three characteristics: a) Gauge size (see Table 1); b)
31、 Nominal length of needle (see Clause 2.1) in inches (see Table 1); c) Type of point as designated in Clause 4. NOTEIt is recommended that for purposes of ordering the method of size designation given in Table 1 should be used. 4 Needle point a) Angle of point. The angle of the needle point shall be
32、 one of the following: i) Long bevel with the angle of 12 + 2 0 degrees (see Figure 1); ii) Short bevel with the angle of 18 1 degrees (see Figure 2). NOTEThe long bevel point is the most generally used and is normally supplied unless the purchaser specifies the short bevel point. b) Finish of the p
33、oint. Needle points shall be sharpened on three aspects as illustrated in Figure 1 and Figure 2 in order to avoid the presence of a weak feather edge. 5 Bore of the needle The bore (lumen) of the needle shall be clean, circular and free from foreign matter. 6 Materials a) Needle tubing. The needle t
34、ubing shall be made of martensitic stainless steel of one of the En 56 series specified in BS 9702), or of austenitic stainless steel of one of the En 58 series specified in BS 970. The needle tubing shall comply with the test requirements for corrosion resistance given in Clause 7 d). b) Needle hub
35、. The needle hub shall be capable of withstanding heat up to 200 C without deformation and shall comply with the requirements for corrosion resistance given in Clause 7 d). 7 Test requirements for hypodermic needles a) Stiffness test. A specimen of needle tubing or a hypodermic needle complete with
36、hub shall be loaded centrally on a span in accordance with Table 2. The deflection shall be not greater than that given for the appropriate gauge and quality of steel of the needle. b) Elasticity test. A specimen of needle tubing shall be held rigidly in a chuck, the jaws of which may be radiused sl
37、ightly. Alternatively a hypodermic needle complete with hub shall be held rigidly at the hub. The specimen shall be deflected in accordance with Table 3. Upon release, the needle shall not have an appreciable permanent set. 2) BS 970 “Wrought steels. En series”. Licensed Copy: sheffieldun sheffieldu
38、n, na, Wed Nov 29 03:27:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3522:1962 2 BSI 10-1999 Table 1 Size range of hypodermic needles Designated size Designated size External diameter of needle tube Minimum bore of needle tube Length of needle For information only: comparison with British Hypode
39、rmic and Serum ranges of sizes max.min.max.min. 26G 1/2 26G 3/4 26G 1 23G 1 23G 11/4 23G 2 21G 11/2 21G 2 19G 2 18G 2 5 13 5 20 5 25 6 25 6 32 6 50 8 40 8 50 10 50 12 50 in 0.018 5 0.018 5 0.018 5 0.025 5 0.025 5 0.025 5 0.032 5 0.032 5 0.043 5 0.050 5 in 0.017 5 0.017 5 0.017 5 0.024 5 0.025 5 0.02
40、4 5 0.031 5 0.031 5 0.040 5 0.047 5 mm 0.470 0.470 0.470 0.648 0.648 0.648 0.826 0.826 1.105 1.283 mm 0.445 0.445 0.445 0.622 0.622 0.622 0.800 0.800 1.029 1.207 in 0.009 5 0.009 5 0.009 5 0.012 5 0.012 5 0.012 5 0.019 5 0.019 5 0.025 5 0.031 5 mm 0.241 0.241 0.241 0.318 0.318 0.318 0.495 0.495 0.64
41、8 0.800 mm 12.5 1.0 20.0 1.0 25.0 1.0 25.0 1.0 31.5 1.5 50.0 1.5 40.0 1.5 50.0 1.5 50.0 1.5 50.0 1.5 Hypo. No. 20 Hypo. No. 18 Hypo. No. 17 Hypo. No. 15 Hypo. No. 12 and 14 Serum No. 6 Hypo. No. 1 Serum No. 4 Serum No. 2 Serum No. 1 NOTEThe diameters and lengths in millimetres of the needles given i
42、n Table 1 are based on the R/10 series of preferred numbers in accordance with BS 2045 “Preferred numbers”. nom. dia. (gauge) nom. length (in) nom. dia. (mm/10) nom. length (mm) Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3522:1962 BS
43、I 10-19993 Table 2 Stiffness test Table 3 Elasticity test c) Reverse bend resistance. A specimen of needle tubing shall be held rigidly in a chuck, the jaws of which may be radiused slightly. Alternatively a hypodermic needle complete with hub shall be held rigidly at the hub. The specimen, held at
44、the distance from the chuck or hub given in Table 4, shall be bent to the right and then to the left to the angle specified, this constituting one complete bending cycle. The specimen shall withstand, without breaking, the number of complete bending cycles given in Table 4. d) Corrosion resistance.
45、The hypodermic needle complete with hub shall be immersed in 10 per cent aqueous citric acid solution at room temperature for 5 hours. After removal of the specimen from the acid solution, it shall be immersed in boiling distilled water for 30 minutes. The water and the immersed needle shall then be
46、 allowed to cool and shall remain at room temperature for 48 hours. Glass containers shall be used for the test. The specimen after having been dried by evaporation shall not show corrosion. 8 Needle hub a) External design. The outer contour of the hub shall be designed so that the mounted needle wi
47、ll not roll on a flat surface. b) Union of needle with hub. The needle tube shall extend well into the hub and shall be concentric with the hub cavity; it shall be securely attached to the hub by swaging or tapping and, if solder is used, it shall be capable of maintaining a secure union at temperat
48、ures up to 200 C. c) Test requirements for union of blade and hub. After heating the needle at 190 + 10 0 C for not less than 30 minutes and cooling in air to room temperature, the needle tube shall withstand, without loosening of the hub, a pull for 1 minute with a load in accordance with Table 5.
49、Table 4 Reverse bend test Designated sizeSpanLoad Maximum deflection En 58 steelEn 56 steel gauge 26 23 21 19 18 mm/10 5 6 8 10 12 in 3/8 5/8 5/8 1 1 (mm) (9.5) (15.9) (15.9) (25.4) (25.4) oz 25 40 50 70 70 (kg) (0.708) (1.134) (1.417) (1.984) (1.984) in 0.019 0.033 0.016 0.033 0.017 (mm) (0.48) (0.84) (0.41) (0.84) (0.43) in 0.015 0.028 0.014 0.027 0.016 (mm) (0.38) (0.71) (0.35) (0.69) (0.41) Designated sizeDeflection Contact distance from chuck or hub gauge 26 23 21 19 18 mm
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