1、BRITISH STANDARD CONFIRMED JULY 1990 BS 3221-1: 1985 Incorporating Amendment No. 1 Medicine measures Part 1: Specification for medicine measures of50mL total graduated capacity UDC 615.473.8:681.121.12:641.517BS3221-1:1985 This British Standard, having been prepared under the directionof the Health
2、Care Standards Committee, waspublished under the authorityofthe Board of BSI andcomes intoeffect on 31October 1985 BSI 08-1999 BS 3221-1 first published February 1960 BS 3221-2 first published September 1962 BS 3221-3 first published February 1966 BS 3221-5 first published November 1966 Combined fir
3、st revision as BS3221-1 October 1985 The following BSI references relate to the work on this standard: Committee reference HCC/20 Draft for comment 84/52445 DC ISBN 0 580 14472 0 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Car
4、e Standards Committee (HCC/-) to Technical Committee HCC/20, upon which the following bodies were represented: Association of National Health Service Supplies Officers Association of the British Pharmaceutical Industry British Medical Association British Surgical Trades Association Incorporated Depa
5、rtment of Health and Social Security Glass Manufacturers Federation Guild of Hospital Pharmacists Medical Sterile Products Association National Pharmaceutical Association Paediatric Pharmacists Group Pharmaceutical Services Negotiating Committee Pharmaceutical Society of Great Britain Proprietary As
6、sociation of Great Britain Royal Society of Medicine Scottish Pharmaceutical Federation Amendments issued since publication Amd. No. Date of issue Comments 5368 August 1986 Indicated by a sideline in the marginBS3221-1:1985 BSI 08-1999 i Contents Page Committees responsible Inside front cover Forewo
7、rd ii 1 Scope 1 2 Definition 1 3 Materials 1 4 Design 1 5 Hydrolytic resistance of glass measures 1 6 Capacity 2 7 Scale 2 8 Stability 2 9 Resistance to hot water 3 10 Rigidity 3 11 Marking 3 Appendix A Guidance for selection of plastics materials 4 Appendix B Method for determination of capacity 4
8、Appendix C Test for resistance to hot water 4 Appendix D Determination of rigidity of plastics medicine measures 4 Figure 1 Examples of designs for50mL medicine measures 1 Figure 2 Scales for50mL medicine measures 2 Figure 3 Suitable apparatus for testing rigidity of plastics measures 5 Publications
9、 referred to Inside back coverBS3221-1:1985 ii BSI 08-1999 Foreword This Part of BS3221 has been prepared under the direction of the Health Care Standards Committee. It is a combined revision of the following Parts of BS3221. Part 1:1960: Glass medicine measures of50mL capacity; Part 2:1962: Glass m
10、edicine measures of30mL capacity; Part 3:1966: Plastics medicine measures of50mL capacity; Part 5:1966: Plastics medicine measures of10mL capacity. This Part supersedes all four Parts listed above. Part1:1960 and Part3:1966 are withdrawn. Parts2 and5 were withdrawn in1983. Plastics medicine measurin
11、g spoons are covered by Parts4 and6 as follows. Part 4: Plastics medicine measuring spoons of5mL capacity 1) ; Part 6: Specification for free-standing plastics medicine measuring spoons of5mL capacity. This Part of BS3221 specifies general requirements and essential performance requirements for meas
12、ures made either of glass or of plastics materials, and which are graduated at doses ranging from10mL to50mL. The accuracy of measurement specified aligns with that specified for plastics medicine spoons, but the design of the measure has not, apart from the scale and graduations, been specified in
13、detail, thus allowing some variation in overall configuration. Test methods and requirements for rigidity and for resistance to hot water are introduced. It has not been found practicable to specify requirements or tests for the biological safety of the materials of which the measure is made, and ne
14、ither are tests given for resistance to staining by commonly used pharmaceutical colorants nor for resistance to detergent and disinfectant solutions.Appendix A, however, contains guidance for the selection of plastics materials for the manufacture of measures. Attention is drawn to BS1922 which spe
15、cifies measures for use by the pharmacist in the preparation of medicines. 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
16、 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) and may have had amendments incorporated. This will be indicated in th
17、e amendment table on the inside front cover. 1) It is intended that Part4 will be withdrawn in1986.BS3221-1:1985 BSI 08-1999 1 1 Scope This Part of BS3221 specifies general design and performance requirements for medicine measures of50mL total graduated capacity made from either glass or plastics ma
18、terials. NOTEThe titles of the publications referred to in this standard are listed on the inside back cover. 2 Definition For the purposes of this Part of BS 3221, the following definition applies. graduated capacity the volume of water at20 2 C required to fill a medicine measure to a given gradua
19、tion mark 3 Materials 3.1 Glass Glass used for the construction of medicine measures shall be of the colourless soda-lime-silica, or colourless boro-silicate, type. Lead-containing glass shall not be used. NOTEThe glass should be as free as possible from visible defects and from internal stress. 3.2
20、 Plastics Plastics measures shall be made of plastics materials that are non-coloured and 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 side of the measure. NOTEFurther guidance on the select
21、ion of plastics materials is given inAppendix A. 4 Design 4.1 Style The body of the medicine measure shall be in the shape of a truncated cone, symmetrical about its vertical axis, with its larger diameter uppermost. NOTEExamples of designs are depicted inFigure 1. 4.2 Surface finish The surfaces of
22、 the measure, when inspected by normal or corrected vision, shall, except for the graduation marks, be smooth and free from striae, blisters, delamination and other visible defects. Junctions of surfaces shall be uniformly rounded. 4.3 Rim The rim shall be smooth and uniformly rounded; it shall not
23、have sharp edges. 4.4 Base The base shall be such that the measure does not rock when placed on a flat horizontal surface. 4.5 Wall thickness The wall thickness shall show no local departure from uniformity. 5 Hydrolytic resistance of glass measures Glass measures, when tested in accordance with BS3
24、473-4:1983 shall require not more than7.8mL of0.01mol/L hydrochloric acid for the titration of100mL of extract solution. NOTEThe designs shown are for example only and do not form part of this specification. Figure 1 Examples of designs for50mL medicine measuresBS3221-1:1985 2 BSI 08-1999 6 Capacity
25、 6.1 Total capacity The total capacity of the measure shall be not less than65mL and shall be such that, when tested in accordance with clause8, no liquid shall spill from the measure. 6.2 Total graduated capacity The total graduated capacity shall be50mL. 6.3 Tolerance on graduated capacities When
26、the capacity at each graduation mark is determined in accordance with Appendix B, the tolerance on the capacity shall be 5% of the nominal capacity at that graduation mark. 7 Scale 7.1 General The measure shall bear one scale only, which shall be as shown in either Figure 2(a) orFigure 2(b). The sca
27、le shall be located on the external surface of the measure, shall be indelibly marked and shall have clean edges. All scale lines shall be distinct and of uniform thickness not exceeding0.5mm. 7.2 Length of scale The vertical distance between the horizontal planes of the10mL and50mL graduation marks
28、 shall be not less than28mm. 7.3 Graduation marks The graduation marks shall lie in planes parallel to the plane of the base of the measure; the length of each mark shall be as shown in eitherFigure 2(a) orFigure 2(b). If marks that extend around the entire circumference of the measure are used, in
29、accordance withFigure 2(b), all graduation marks on that scale shall be of this type. 7.4 Numbering of graduation marks Every graduation mark shall be numbered. The numbers shall be of height between2mm and3mm, and shall be situated as shown in Figure 2(a) and Figure 2(b) in such a position that the
30、y would be bisected by a prolongation of the graduation marks to which they refer. The abbreviation “ml” shall appear above the number designating the50mL graduation mark. 8 Stability When the measure is filled with water to the50mL graduation mark and placed on a flat surface which is then inclined
31、 until it is at angle of15 to the horizontal, the measure shall not topple over. NOTEIt may be necessary to prevent the measure from sliding down the inclined surface, for example by means of a small stop made of wood, modelling clay, etc. NOTEGraduation marks may extend around the entire circumfere
32、nce, in which case dimensions b 1and b 2do not apply (see7.3). Scale (b) Figure 2 Scales for50mL medicine measuresBS3221-1:1985 BSI 08-1999 3 9 Resistance to hot water When tested in accordance withAppendix C: a) plastics measures, immediately after testing, shall not be asymmetrical or otherwise di
33、storted and shall comply with the requirements of4.2 to4.5. The rigidity of the measure shall be as specified in clause10; b) glass measures shall not break or crack; c) there shall be no visible deterioration in the clarity of the scale markings of either plastics or glass measures and the toleranc
34、e on capacities shall be as specified in clause6. 10 Rigidity When tested in accordance withAppendix D, plastics measures shall show no change in diameter greater than6% of the original diameter of the measure. 11 Marking The medicine measure shall be clearly and indelibly marked with the number and
35、 date of this Part of this British Standard, i.e. BS3221-1:1985 2) . This information shall be located either above the “ml” mark or on the underside of the base. The name or trademark of the manufacturer or vendor, if marked, shall be situated on the underside of the base. 2) Marking BS3221-1:1985
36、on or in relation to a product is a claim by the manufacturer that the product has been manufactured to the requirements of the standard. The accuracy of such a claim is therefore solely the manufacturers responsibility. Enquiries as to the availability of third party certification to support such c
37、laims should be addressed to the Director, Quality Assurance Division, BSI, PO Box 375, Milton Keynes MK14 6LO for certification marks administered by BSI or to the appropriate authority for other certification marks.BS3221-1:1985 4 BSI 08-1999 Appendix A Guidance for selection of plastics materials
38、 Past experience has shown that plastics materials with appropriate thermal and mechanical properties and which comply with the recommendations 3)of the British Plastics Federation for food contact, are suitable for the manufacture of medicine measures. The plastics material should not include in it
39、s composition any substance which, under conditions of use, could be extracted by oral liquid medicines in quantities sufficient to cause a toxic hazard. The measure should be resistant to staining by colouring substances commonly used in pharmaceutical practice, and should withstand, without deteri
40、oration, treatment with detergent solutions, and hypochlorite solution and other antiseptic solutions in common use. It is not intended that plastics measures which comply with this standard should be used with paraldehyde or certain other medicaments which are known to react with plastics materials
41、. It is important that if materials are used other than those known to be satisfactory by long usage, their performance and characteristics should not be inferior to the traditional materials used. Appendix B Method for determination of capacity Set the clean and dry medicine measure on a flat, hori
42、zontal surface. Position the line of sight of the operator so that it is at the same level as the selected graduation mark. Run distilled water at20 2 C into the measure from a burette complying with class B of BS846 until the measure has been filled to the selected graduation mark, in accordance wi
43、th either a) or b) as appropriate: a) for plastics measures, when the surface of the water appears level with the top edge of the graduation mark; b) for glass measures, when the lower surface of the water meniscus appears to touch the top edge of the graduation mark. Record the volume of water adde
44、d. Make a total of10 determinations. Calculate the average value of the water volume. Take this as the capacity of the measure at that graduation mark. Appendix C Test for resistance to hot water Completely immerse the measure in water at a temperature of70 2 C. After not less than120s, remove the m
45、easure, place it on a flat surface and allow it to cool to ambient temperature. Repeat the procedure until20 immersions have been performed. Examine the measure by normal or corrected vision for signs of deterioration. If there are no signs of deterioration perform the following tests. a) Determine
46、the capacity at each graduation mark in accordance withAppendix B. b) Determine the rigidity of plastics measures in accordance withAppendix D. Appendix D Determination of rigidity of plastics medicine measures D.1 Apparatus D.1.1 Test apparatus, capable of applying a test load equivalent to a force
47、 of16N via a steel ball of6mm diameter. NOTEA suitable machine is shown inFigure 3. With this machine the test load is exerted by the unweighted lever arm provided that the mass of the arm is800g and the steel ball is located150mm from the pivot. D.1.2 Measuring calipers, with vernier scale, capable
48、 of measurement to the nearest0.1mm, and of design suitable for measurement of the outside diameter of medicine measures and the movement of the lever arm; or other measuring apparatus, e.g.a projection microscope, having the same accuracy. D.2 Procedure D.2.1 Perform the test at a temperature in th
49、e range18 C to25 C. D.2.2 Measure and record the outside diameter of the measure at the30mL graduation mark, making five measurements. D.2.3 Position the measure in the test apparatus so that the steel ball is just touching the measure at the highest point of the circumference at the30mL graduation mark. NOTEIf the apparatus shown inFigure 3 is used, position the measure on wooden blocks so that the lever arm is level when the steel ball is just touching the measure. D.2.4 Apply a load of16N to the measure. After a period of15s, measure and
