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1、BRITISH STANDARD BS 3221-7: 1995 Medicine measures Part 7: Specification for oral syringes delivering doses up to and including 5 ml UDC 615.473.4 + .8 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3221-7:1995 This British Standard, hav
2、ing been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 November 1995 BSI 07-1999 First published November 1986 Second edition November 1995 The following BSI references relate to the work
3、on this standard: Committee reference CH/20 Draft for comment 94/502532 DC ISBN 0 580 24642 6 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/20, Medical measuring vessels, upon which the following bodies were represen
4、ted: Association of the British Pharmaceutical Industry British Glass Manufacturers Confederation British Medical Association Department of Health Guild of Hospital Pharmacists Medical Sterile Products Association National Association of Health Care Supplies Managers National Pharmaceutical Associat
5、ion Paediatric Pharmacists Group Pharmaceutical Services Negotiating Committee Royal Pharmaceutical Society of Great Britain Royal Society of Medicine Scottish Pharmaceutical Federation Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03
6、:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3221-7:1995 BSI 07-1999i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope1 2 References1 3 Definitions1 4 Materials1 5 Design1 6 Capacity1 7 Graduated scale2 8 Freedom from liquid leakage3 9 Resistance to washing3 10 Res
7、istance to breakage (bite forces)3 11 Freedom from air leakage3 12 Marking and labelling3 Annex A (informative) Guidance for selection of materials4 Annex B (normative) Test for resistance to washing4 Annex C (normative) Test for determination of capacity4 Annex D (normative) Test for freedom from l
8、iquid leakage4 Annex E (normative) Test for resistance to breakage (bite forces)4 Annex F (normative) Test for freedom from air leakage6 Figure E.1 Suitable apparatus for testing resistance to breakage (bite forces)5 Table 1 Nominal capacity and intervals at which syringes are graduated2 Table 2 Int
9、ervals at which syringes are numbered2 List of references Inside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3221-7:1995 ii BSI 07-1999 Foreword This Part of BS 3221 has been prepared by Technical Committee CH/20 and supers
10、edes BS 3221-7:1986 which will be withdrawn on 1st May 1996. This revision introduces the addition of the 2.5 ml mark on the 5 ml syringe. It also clarifies the test method for the determination of the capacity of a syringe given in Annex C. Other current Parts of BS 3221 are as follows. Part 1: Spe
11、cification for medicine measures of 50 mL total graduated capacity; Part 6: Specification for free-standing plastics medicine measuring spoons of 5 mL capacity. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for t
12、heir 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 and ii, pages 1 to 6, an inside back cover and a back cover. This standard has been updated (
13、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 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3221-7:1995 BSI 07-19991 1 Scope This Part of BS 3221 s
14、pecifies general design and performance requirements for three size ranges of oral syringe for containing and delivering liquid medicines in measured volumes of up to and including 5 ml. 2 References 2.1 Normative references This Part of BS 3221 incorporates, by dated or undated reference, provision
15、s from other publications. These normative references are made at the appropriate places in the text and the cited publications are listed on the inside back cover. For dated references, only the edition cited applies; any subsequent amendments to, or revisions of, the cited publication apply to thi
16、s Part of BS 3221 only when incorporated in the reference by updating or revision. For undated references, the latest edition of the cited publication applies, together with any amendments. 2.2 Informative references This Part of BS 3221 refers to other publications that provide information or guida
17、nce. Editions of these publications current at the time of issue of this standard are listed on the inside back cover, but reference should be made to the latest editions. 3 Definitions For the purposes of this British Standard the following definition applies. graduated capacity the volume of water
18、 at (20 2) C expelled by the syringe when the fiducial line on the piston traverses the interval between a given graduation line and the zero line 4 Materials Materials used for the construction of syringe barrels shall be either transparent or translucent. The clarity shall be such that the surface
19、 of a colourless liquid can be seen by normal or corrected vision through the syringe barrel. NOTEFurther guidance on the selection of materials is given in Annex A. 5 Design 5.1 Function It shall be possible to displace the measured contents of the syringe directly into the patients mouth. NOTE 1It
20、 is desirable that when the syringe is put down on a flat surface any part that normally enters the patients mouth during delivery of the medicine should not be in contact with that surface. NOTE 2If an adaptor is supplied with the syringe for the purpose of filling the syringe directly from a medic
21、ine container, the adaptor should: a) be made of materials having the properties described in Annex A; b) form a leak-free seal with the syringe during aspiration of the medicine; c) show no distortion or other deleterious effects when tested for resistance to washing as described in Annex B. 5.2 Su
22、rface finish The surfaces of the syringe, when inspected by normal or corrected vision shall, except for graduation marks, be smooth and free from striae, blisters, delamination and other visible defects. Junctions of surfaces shall be uniformly rounded. The syringe shall be free from flash and shar
23、p edges. 5.3 Finger grips The open end of the barrel shall be provided with finger grips that shall also ensure that the syringe will not roll when it is placed with the scale uppermost on a flat surface inclined at an angle of 10 to the horizontal. NOTEFinger grips should be of adequate size, shape
24、 and strength for the intended purpose and should enable the syringe to be held securely during use. 5.4 Delivery ends of barrel It shall not be possible to attach directly to the delivery end of the barrel a hypodermic needle having a Luer (6 %) conical taper fitting conforming to BS EN 20594-1:199
25、4. 5.5 Fiducial line For determining the capacity corresponding to any scale reading of the syringe, the fiducial line shall be a clearly visible and distinct edge at the leading end of the piston, and shall be in contact with the inner surface of the barrel. 5.6 Plunger The protruding part of the p
26、lunger or piston rod shall be equipped with a button. NOTEThe button may be of circular or other shape and should have a plane or, preferably, a concave face. The button and plunger should be of a suitable size and design to: a) allow digital pressure to be applied to the piston for the ejection of
27、liquid from the syringe; and b) facilitate the withdrawal of the piston when filling the syringe. 6 Capacity 6.1 Nominal capacity The nominal capacity of the syringe shall be defined as the total graduated capacity and shall be within the range of capacities shown in Table 1. Licensed Copy: sheffiel
28、dun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3221-7:1995 2 BSI 07-1999 Table 1 Nominal capacity and intervals at which syringes are graduated 6.2 Tolerance on graduated capacities When the capacity at each graduation line is determined in accordance with the
29、 method given in Annex C, the tolerance on the capacity shall not differ by more than 5 % of the capacity indicated at that graduation. 7 Graduated scale 7.1 Scale The scale shall comprise graduation lines and numbers. The scale shall be located on the external surface of the barrel. There shall be
30、not more than one scale. 7.2 Graduation lines The graduation lines shall be legible, indelible (see clause 9) and of uniform thickness not exceeding 0.6 mm. Graduation lines shall be evenly spaced between zero and the total graduated capacity and shall lie in planes at right angles to the longitudin
31、al axis of the barrel. Graduation lines shall be located at the intervals specified in Table 1. When the syringe is held vertically with the delivery end uppermost and with the scale towards the viewer, the left hand ends of all the graduation lines shall lie vertically beneath each other. NOTEThe l
32、eft hand ends of the graduation lines may optionally be joined by a line parallel to the longitudinal axis of the barrel. 7.3 Overall length of scale The minimum length of the scale between the zero line and the total graduated capacity line shall be 35 mm. 7.4 Position of scale When the piston is f
33、ully inserted, that is as near to the delivery end of the barrel as it will go, the zero graduation line of the scale shall appear to touch the fiducial line (see 5.5). 7.5 Numbering of scale The graduation lines to be numbered shall be as given in Table 2. Table 2 Intervals at which syringes are nu
34、mbered The numbers shall be bold and legible. When the syringe is held vertically with the delivery end uppermost and with the scale towards the viewer, the numbers shall be upright. The numbers shall be close to, but shall not touch, the ends of the graduation lines to which they relate. 7.5.1 Numb
35、ering of syringe of nominal capacity of up to 5 ml The numbers shall either: a) be on the right of the scale, and in a position such that they would be bisected by a prolongation of the graduation lines to which they relate; or b) bisect the graduation lines to which they relate. 7.5.2 Numbering of
36、syringe of nominal capacity of 5 ml The numbers shall: a) be on the right of the scale, and in a position such that they would be bisected by a prolongation of the graduation lines to which they relate; and b) the 2.5 ml mark shall be on the left of the scale, and in a position such that it would be
37、 bisected by a prolongation of the graduation line. 7.6 Length of graduation lines The numbered graduation lines shall be of uniform length, which shall be not less than 9 % of the circumference of the barrel. The combined length of the line and the width of the number, including the space between t
38、he two, shall be not more than 30 % of the circumference of the barrel. The unnumbered graduation lines shall be of uniform length which shall be less than, but not less than half, the length of the numbered graduation lines. Nominal capacity of syringeGraduated at intervals of: mlml Over 3 and up t
39、o and including 5 0.5 Over 1, up to and including 30.25 1 or less0.1 Nominal capacity of syringeGraduated at intervals of: mlml 51.0 and 2.5a Over 3 and up to 51.0 Over 1, up to and including 30.5 1 or less0.2 a See 7.5.2. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 200
40、6, Uncontrolled Copy, (c) BSI BS 3221-7:1995 BSI 07-19993 8 Freedom from liquid leakage When tested in accordance with the method given in Annex D, the loss of mass shall be not greater than 0.025 g. 9 Resistance to washing When tested in accordance with the method given in Annex B, the syringe shal
41、l not become asymmetrical or otherwise distorted, there shall be no loss of clarity or legibility of markings and the syringe shall retain conformity to 5.2, 6.2, and clauses 8, 10 and 11. 10 Resistance to breakage (bite forces) When tested in accordance with the method given in Annex E, neither the
42、 end of the syringe which is intended to enter the mouth during delivery of the medicine, nor the syringe barrel shall break into fragments or crack. 11 Freedom from air leakage When tested in accordance with the method given in Annex F, no air bubbles shall be visible in the liquid in the barrel. 1
43、2 Marking and labelling 12.1 Marking The syringe shall be permanently and legibly marked with the following information: a) the abbreviation “ml” either below the total graduated capacity number on the scale or beside the numbered graduation lines; b) the words “FOR ORAL USE ONLY”; c) the number and
44、 date of this British Standard, i.e. BS 3221-7:19951), or an abbreviated version (e.g. BS 3221-7:1995). NOTEThe syringe may be marked with the name or trademark of the manufacturer or vendor. 12.2 Labelling Printed instructions shall be supplied with each syringe for the guidance of users, and shall
45、 make reference to the following: a) the purpose of the syringe; b) the method of filling the syringe, including guidance on the transfer of medicine from the original container and the removal of air bubbles; c) the method of measuring the prescribed dose; d) the method of administration of the med
46、icine, including: 1) the need to avoid too rapid a displacement of the dose; 2) the correct placement of the end of the syringe in the patients mouth; 3) the need for the patient, especially if a child, to be in a sitting position at the time of administration; e) the method of cleaning. NOTEThe for
47、m of presentation of the instructions is not specified in this British Standard. It is recommended that pictures or diagrams be used to clarify or reinforce the printed instructions. 1) Marking BS 3221-7:1995 on or in relation to a product represents a manufacturers declaration of conformity, i.e. a
48、 claim by or on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is solely the claimants responsibility. Such a declaration is not to be confused with third party certification of conformity, which may also be desirable. Licensed Copy: she
49、ffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3221-7:1995 4 BSI 07-1999 Annex A (informative) Guidance for selection of materials Past experience has shown that plastics materials with appropriate thermal and mechanical properties that conform to the recommendations 1 of the British Plastics Federation for food contact are suitable for the manufacture of oral syringes. The plastics material should not include in its composition any substance which, under conditions of use, could be extracted by oral liquid
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