1、BRITISH STANDARD BS 3221-6: 1987 Medicine measures Part 6: Specification for free-standing plastics medicine measuring spoons of5mL capacity UDC 615.473.8+681.121.12BS3221-6:1987 This British Standard, having been prepared under the directionof the Health Care Standards Committee, was published unde
2、r the authority ofthe Board of BSI and comes intoeffect on 30 January 1987 BSI 02-2000 First published October 1983 First revision January 1987 The following BSI references relate to the work on this standard: Committee reference HCC/20 Draft for comment 86/51173 DC ISBN 0 580 15710 5 Committees res
3、ponsible for this British Standard The preparation of this British Standard was entrusted by the Health Care 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 Britis
4、h Pharmaceutical Industry British Medical Association British Surgical Trades Association Incorporated Department of Health and Social Security Glass Manufacturers Federation Guild of Hospital Pharmacists Medical Sterile Products Association National Pharmaceutical Association Paediatric Pharmacists
5、 Group Pharmaceutical Services Negotiating Committee Pharmaceutical Society of Great Britain Proprietary Association of Great Britain Royal Society of Medicine Scottish Pharmaceutical Federation Amendments issued since publication Amd. No. Date of issue CommentsBS3221-6:1987 BSI 02-2000 i Contents P
6、age Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Material of construction 1 3 Capacity 1 4 Design 1 5 Impact resistance 1 6 Resistance to breakage 1 7 Resistance to hot water 1 8 Marking 1 Appendix A Guidance for selection of materials 2 Appendix B Method for determination of ca
7、pacity 2 Appendix C Test for rigidity of handle 2 Appendix D Test for resistance to breakage 2 Appendix E Test for resistance to hot water 2 Figure 1 Dimensions of spoon 3 Figure 2 Suitable apparatus for testing resistance to breakage 4 Publications referred to Inside back coverBS3221-6:1987 ii BSI
8、02-2000 Foreword This revision of BS3221-6 has been prepared under the direction of the Health Care Standards Committee. BS3221-6 was first published in1983 at the request of the Pharmaceutical Society of Great Britain, responding to the need for a more robust spoon that would be easier to manipulat
9、e. This revision of BS3221-6, in addition to superseding the1983 edition (which is now withdrawn), also supersedes BS3221-4:1969 which, after running concurrently with the1983 edition of BS3221-6, was withdrawn in May1986. BS3221-4, dealing with plastics medicine measuring spoons of5mL capacity, was
10、 first published in1966 in order to meet the need for a simple device, mainly for domestic use, which would measure and deliver all liquid medicines in a standard metric dose. The provision of the5mL spoon was an essential element in the changeover to the metric system in the dispensing and supply o
11、f medicine, which took effect in March1969. BS3221-4 was revised in1969 primarily to give an improved method of test for the capacity of the spoon and to provide additional details for dimensional requirements. BS3221-6:1983 retained the basic design of the bowl of the spoon specified in BS3221-4:19
12、69, together with a number of the requirements and test methods, but differed in several major respects. The handle was redesigned in order to make handling and filling of the spoon easier, to reduce the risk of spillage, to provide a more positive grip for the user and to maintain the filled spoon
13、in a level state when it was set down on a flat surface. For reasons of hygiene, the design of the spoon specified in BS3221-4 precluded it being set down on a flat surface when filled. The view of the Technical Committee that prepared BS3221-6:1983 was that the risks arising from setting down a fil
14、led spoon were outweighed by the advantages of a free-standing spoon in terms of reduced spillage and consequent increased accuracy of dosage, especially when medicines were administered to young or uncooperative children, or by adults of reduced manual dexterity or coordination. Test methods and re
15、quirements for rigidity, impact resistance, resistance to breakage and resistance to hot water were also introduced. It was not found practicable to specify requirements or tests for the biological safety of the materials of which the spoon was made, neither were tests given for resistance to staini
16、ng by commonly used pharmaceutical colourants nor for resistance to detergent and disinfectant solutions. Appendix A, however, gave guidance for the selection of materials for the manufacture of spoons. This revision of BS3221-6 differs from the1983 edition in the following ways. The fluid used in m
17、easuring the capacity of the spoon has been changed from water to a sucrose solution because the latter gives more reproducible test results and is more representative of the fluids with which the spoon is typically used in practice. The tolerances on some of the bowl dimensions have been widened sl
18、ightly in order to facilitate achievement of the specified volumetric accuracy, and graduation marks on the bowl are actively proscribed. The marking requirements have been amended in order to provide for abbreviated markings on the spoon, and the inclusion of the date of the standard is now optiona
19、l. Other current Parts of this British Standard are: Part 1: Specification for medicine measures of50mL total graduated capacity; Part 7: Specification for oral syringes delivering doses of less than5mL.BS3221-6:1987 BSI 02-2000 iii Part 2 dealing with glass measures of30mL capacity, Part3 dealing w
20、ith plastics measures of50 mL capacity and Part5 dealing with plastics measures of10mL capacity have been withdrawn, being superseded by Part1. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct appl
21、ication. 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 toiv, pages1 to4, an inside back cover and a back cover. This standard has been updated (see copyright date) an
22、d may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.iv blankBS3221-6:1987 BSI 02-2000 1 1 Scope This Part of BS3221 specifies the basic requirements for free-standing medicine measuring spoons of5mL capacity made from plastics materials. NO
23、TEThe titles of the publications referred to in this standard are listed on the inside back cover. 2 Material of construction The spoon shall be made of a plastics material that is either non-coloured and transparent or translucent, or is coloured white. NOTE 1For ease of differentiation of medicine
24、 spoons from other spoons made of plastics material, the spoon should preferably be non-coloured and transparent or translucent. NOTE 2Further guidance on the selection of materials of construction is given inAppendix A. 3 Capacity The nominal capacity of the spoon shall be5mL. The capacity of the s
25、poon, when tested in accordance with Appendix B, shall be5.0 0.25mL. 4 Design 4.1 Surface finish The surfaces of the spoon, when inspected by normal or corrected vision, shall be smooth and free from blisters, delaminations, flow lines and other visible defects. There shall be no sharp edges and all
26、 edges and corners shall be radiussed. 4.2 Bowl The dimensions of the bowl shall be in accordance with those shown inFigure 1. The rim of the bowl shall lie in one plane. The bowl shall not be graduated. 4.3 Handle The dimensions of the handle shall be in accordance with those shown inFigure 1. The
27、design of the handle shall be such that: a) its distal end provides a steadying support and also positions the rim of the bowl in a horizontal plane when the spoon is placed on a flat horizontal surface; b) it provides two vertical surfaces a minimum of8mm apart which can be gripped between forefing
28、er and thumb when the spoon is held in the hand; c) it is of sufficient rigidity that, when tested in accordance withAppendix C, the tip of the bowl is not displaced vertically by more than4mm; d) it is either of hollow or solid construction. 5 Impact resistance The spoon shall be capable of withsta
29、nding a free fall from a height of1.3m on to a concrete or similar hard surface without breaking or showing visible damage. 6 Resistance to breakage When tested in accordance with Appendix D, the spoon shall not break into fragments. NOTEPermanent or temporary deformation of the spoon or the occurre
30、nce of cracks does not constitute failure of the test. 7 Resistance to hot water When tested in accordance with Appendix E, the spoon, immediately after testing, shall not be asymmetrical or otherwise visibly distorted, nor shall there be any deterioration in surface finish (see4.1). The rigidity of
31、 the handle shall be as specified in4.3 c). The impact resistance of the spoon shall be as specified in clause5, the resistance to breakage of the spoon shall be as specified in clause6 and the capacity of the spoon shall be as specified in clause3. 8 Marking The spoon shall be clearly and permanent
32、ly marked with the following particulars: a) on the upper surface of the handle, the words “5ml dose”, the dimensions of which shall comply with those shown inFigure 1; b) on any surface of the handle, other than the upper surface, the number of this British Standard, i.e. BS3221-6 1) , either in fu
33、ll or in abbreviated form. Abbreviated marking shall contain the number “BS3221” in full, immediately followed on the same level by an indication of the Part number. NOTE 1The word “Part” may be abbreviated to “Pt” or may be replaced by a symbol, preferably the oblique stroke (/). The full or abbrev
34、iated date of this Part of BS3221 may also be marked behind, above or below the standard number, and close to it. NOTE 2The name or trade mark of the manufacturer or vendor may also be marked on any surface of the handle other than the upper surface. 1) Marking BS3221-6 on or in relation to a produc
35、t 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 should be addressed to the appropriate certifi
36、cation body.BS3221-6:1987 2 BSI 02-2000 Appendix A Guidance for selection of materials Past experience has shown that plastics materials with appropriate thermal and mechanical properties and which comply with the recommendations 2)of the British Plastics Federation for food contact, are suitable fo
37、r the manufacture of measuring spoons. If any colouring substances are added they should be of a material that is physiologically inert and of a grade suitable for food contact. The plastics material should not include in its composition any substance which, under conditions of use, could be extract
38、ed by vehicles used in oral liquid medicines in quantities sufficient to cause a toxic hazard. The spoon should be resistant to staining by colouring substances commonly used in pharmaceutical practice and should withstand, without deterioration, treatment with detergent solutions, hypochlorite solu
39、tion and other antiseptic solutions in common use. It is important that, if the plastics materials used are other than those known to be satisfactory through long usage, their performance and characteristics should not be inferior to the traditional materials used. Attention is drawn to the Material
40、s and Articles in Contact with Foodstuffs Regulations SI1978 number1927 and the Amendment SI1980 number1838. Appendix B Method for determination of capacity Set the measuring spoon on a flat, level surface. Clamp a steel needle vertically over the centre of the bowl and adjust the height of the need
41、le point to1.70mm above the plane of the rim, using a feeler gauge. Run a solution of sucrose440g/L in distilled water equivalent to a50% (V/V) solution of syrupBP, at20 2 C, into the spoon from a10mL burette until the meniscus just touches the needle point and record the volume of liquid added. Per
42、form10 determinations and calculate the average value of the liquid volume. This shall then be taken as the capacity of the spoon. Appendix C Test for rigidity of handle Clamp the handle of the spoon10mm from its distal end so that the bowl of the spoon is horizontal. Place a vertical scale, calibra
43、ted in millimetres, beside the tip of the bowl. Apply a force equivalent to a load of20g through the point of maximum depth of the bowl (see point D inFigure 1) and read from the scale the vertical displacement of the tip of the bowl. Record the value of the displacement. Appendix D Test for resista
44、nce to breakage Place the spoon in an inverted position with the rim of the bowl on a rigid plane. Apply a total static load equivalent to a force of110N to the bowl of the spoon via a steel ball of6mm diameter, positioned so that the ball makes contact with the surface of the inverted bowl at the p
45、oint of maximum depth (see point D inFigure 1). Apply the load for15s and then remove it. Examine the spoon by normal or corrected vision for evidence of fragmentation. NOTEThe applied load, equivalent to a force of110N, includes the force due to the mass of the steel ball and of the appropriate par
46、ts of the test apparatus. Details of a suitable test apparatus are shown inFigure 2. Appendix E Test for resistance to hot water Completely immerse the spoon in water at a temperature of70 2 C. After not less than120s remove the spoon, place it on a flat surface and allow it to cool to ambient tempe
47、rature. Repeat the procedure until20 immersions have been performed. Examine the spoon by normal or corrected vision for signs of deterioration. If there are no signs of deterioration perform the following tests: a) determine the capacity of the spoon in accordance withAppendix B; b) determine the r
48、igidity of the handle in accordance withAppendix C; c) determine the impact resistance of the spoon in accordance with clause5; d) determine the resistance to breakage of the spoon in accordance with Appendix D. 2) Plastics for Food Contact Applications. A Code of Practice for Safety in Use, revised
49、 edition1981, published by the British Plastics Federation, with the cooperation of the British Industrial Research Association.BS3221-6:1987 BSI 02-2000 3 NOTEOnly those dimensions shown in the figure or specified in the text are to be regarded as part of the standard. Other designs, e.g.with tapered handles in plan view, or with more than point contact between the distal end of the handle and the surface on which it rests, are permissible provided that compliance with all other requirements is maintained. All dimensions are in millimetres. Figure 1 Dimens
