BS 3221-7-1995 Medicine measures - Specification for oral syringes delivering doses up to and including 5 ml《药用量具 第7部分 剂量不超过5ml的口腔注射器规范》.pdf

1、BRITISH STANDARD BS 3221-7: 1995 Medicine measures Part 7: Specification for oral syringesdelivering doses up to andincluding 5ml UDC 615.473.4 + .8BS3221-7:1995 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, was published under the authori

2、ty ofthe Standards Board and comesinto effect on 15November1995 BSI 07-1999 First published November 1986 Second edition November 1995 The following BSI references relate to the work on this standard: Committee reference CH/20 Draft for comment 94/502532 DC ISBN 0 580 24642 6 Committees responsible

3、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 represented: Association of the British Pharmaceutical Industry British Glass Manufacturers Confederation British Medical Ass

4、ociation Department of Health Guild of Hospital Pharmacists Medical Sterile Products Association National Association of Health Care Supplies Managers National Pharmaceutical Association Paediatric Pharmacists Group Pharmaceutical Services Negotiating Committee Royal Pharmaceutical Society of Great

5、Britain Royal Society of Medicine Scottish Pharmaceutical Federation Amendments issued since publication Amd. No. Date CommentsBS3221-7:1995 BSI 07-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 References 1 3 Definitions 1 4 Materials 1 5 Design 1 6 Capacity

6、1 7 Graduated scale 2 8 Freedom from liquid leakage 3 9 Resistance to washing 3 10 Resistance to breakage (bite forces) 3 11 Freedom from air leakage 3 12 Marking and labelling 3 Annex A (informative) Guidance for selection of materials 4 Annex B (normative) Test for resistance to washing 4 Annex C

7、(normative) Test for determination of capacity 4 Annex D (normative) Test for freedom from liquid leakage 4 Annex E (normative) Test for resistance to breakage (bite forces) 4 Annex F (normative) Test for freedom from air leakage 6 Figure E.1 Suitable apparatus for testing resistance to breakage (bi

8、teforces) 5 Table 1 Nominal capacity and intervals at which syringes are graduated 2 Table 2 Intervals at which syringes are numbered 2 List of references Inside back coverBS3221-7:1995 ii BSI 07-1999 Foreword This Part of BS3221 has been prepared by Technical Committee CH/20 and supersedes BS 3221-

9、7:1986 which will be withdrawn on 1st May 1996. This revision introduces the addition of the 2.5ml mark on the 5ml syringe. It also clarifies the test method for the determination of the capacity of a syringe given in Annex C. Other current Parts of BS3221 are as follows. Part 1: Specification for m

10、edicine measures of 50mL total graduated capacity; Part 6: Specification for free-standing plastics medicine measuring spoons of 5mL capacity. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct appli

11、cation. 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, pagesi andii, pages1 to6, an inside back cover and a back cover. This standard has been updated (see copyright date) an

12、d may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.BS3221-7:1995 BSI 07-1999 1 1 Scope This Part of BS3221 specifies general design and performance requirements for three size ranges of oral syringe for containing and delivering liquid med

13、icines 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, provisions from other publications. These normative references are made at the appropriate places in the text and the cited publications are

14、 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 this Part of BS3221 only when incorporated in the reference by updating or revision. For undated references, the latest edition of the

15、 cited publication applies, together with any amendments. 2.2 Informative references This Part of BS3221 refers to other publications that provide information or guidance. Editions of these publications current at the time of issue of this standard are listed on the inside back cover, but reference

16、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 at (20 2) C expelled by the syringe when the fiducial line on the piston traverses the interval between a given graduation line and

17、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 of a colourless liquid can be seen by normal or corrected vision through the syringe barrel. NOTEFurther guidance on the selection o

18、f 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 is desirable that when the syringe is put down on a flat surface any part that normally enters the patients mouth during delivery of

19、 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 medicine container, the adaptor should: a) be made of materials having the properties described in Annex A; b) form a leak-free seal with

20、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 Surface finish The surfaces of the syringe, when inspected by normal or corrected vision shall, except for graduation marks, be smooth

21、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 sharp 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

22、 not roll when it is placed with the scale uppermost on a flat surface inclined at an angle of10 to the horizontal. NOTEFinger grips should be of adequate size, shape and strength for the intended purpose and should enable the syringe to be held securely during use. 5.4 Delivery ends of barrel It sh

23、all 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 BSEN20594-1:1994. 5.5 Fiducial line For determining the capacity corresponding to any scale reading of the syringe, the fiducial line shall be a clearly

24、 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 plunger or piston rod shall be equipped with a button. NOTEThe button may be of circular or other shape and should have a plane or, prefer

25、ably, 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 liquid from the syringe; and b) facilitate the withdrawal of the piston when filling the syringe. 6 Capacity 6.1 Nominal capacity The nom

26、inal capacity of the syringe shall be defined as the total graduated capacity and shall be within the range of capacities shown in Table 1.BS3221-7:1995 2 BSI 07-1999 Table 1 Nominal capacity and intervals atwhich syringes are graduated 6.2 Tolerance on graduated capacities When the capacity at each

27、 graduation line is determined in accordance with the 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

28、 the external surface of the barrel. There shall be not more than one scale. 7.2 Graduation lines The graduation lines shall be legible, indelible (seeclause 9) and of uniform thickness not exceeding 0.6mm. Graduation lines shall be evenly spaced between zero and the total graduated capacity and sha

29、ll lie in planes at right angles to the longitudinal 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

30、shall lie vertically beneath each other. NOTEThe left 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 zeroline and the total graduated capacity line shallbe 3

31、5mm. 7.4 Position of scale When the piston is fully 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 Tabl

32、e 2. Table 2 Intervals at which syringes are numbered 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 gr

33、aduation lines to which they relate. 7.5.1 Numbering 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

34、lines to which they relate. 7.5.2 Numbering of 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 2.5ml mark shall be on the left of the

35、scale, and in a position such that it would be 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

36、 of the number, including the space between the 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 syringe Gr

37、aduated at intervals of: ml ml Over 3 and up to and including 5 0.5 Over 1, up to and including 3 0.25 1 or less 0.1 Nominal capacity of syringe Graduated at intervals of: ml ml 5 1.0 and 2.5 a Over 3 and up to 5 1.0 Over 1, up to and including 3 0.5 1 or less 0.2 a See 7.5.2.BS3221-7:1995 BSI 07-19

38、99 3 8 Freedom from liquid leakage When tested in accordance with the method given inAnnex 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 shall not become asymmetrical or otherwise distorted, ther

39、e 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 end of the syringe which is intended to enter the mou

40、th 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. 12 Marking and labelling 12.1 Marking The syringe shall

41、 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 date of this British Standard, i.e.BS3221-7:1995 1) ,

42、 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 make reference to the following: a) the purpose of th

43、e 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 medicine, including: 1) the need to avoid too rapid a dis

44、placement 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 form of presentation of the instructions is not specified

45、 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 claim by or on behalf of the manufacturer that the pr

46、oduct 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. BS3221-7:1995 4 BSI 07-1999 Annex A (informative) Guidance for selection

47、 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

48、its composition any substance which, under conditions of use, could be extracted by oral liquid medicines in quantities sufficient to cause a toxic hazard. It is not intended that syringes that conform to this standard should be used with paraldehyde or certain other medicaments which are known to r

49、eact with plastics materials. Glass used for the construction of syringes should be of the colourless soda-lime-silica or colourless borosilicate type. Lead-containing glass should not be used. The syringe should be resistant to staining by colouring substances commonly used in pharmaceutical practice, and should withstand, without deterioration, treatment with hypochlorite solution and other antiseptic solutions in common use. It is important that, if materials are used other than those known to be satisfactory by long usage, their performance and cha