BS 5452-1977 Specification for hospital hollow-ware made of plastics material《医院用塑料凹形器皿规范》.pdf

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1、BRITISH STANDARD BS5452:1977 Specification for Hospital hollow-ware made of plastics material UDC 615.478.77:678.5BS5452:1977 This British Standard, having been prepared under the directionof the Surgical Instruments and Medical Appliances Standards Committee,was published underthe authority of theE

2、xecutive Board on 28February1977 BSI 11-1999 The following BSI references relate to the work on this standard: Committee referenceSGS/7 Draft for comment75/62412DC ISBN 0 580 09571 1 Cooperating organizations The Surgical Instruments and Medical Appliances Standards Committee, under whose supervisio

3、n this British Standard was prepared, consists of representatives from the following Government departments and professional and industrial organizations: Association of Anaesthetists of Great Britain and Northern Ireland Association of British Sterilizer Manufacturers British Dental Association Bri

4、tish Institute of Surgical Technicians* British Medical Association British Paediatric Association British Rubber Manufacturers Association Limited British Surgical Trades Association (Inc.)* Department of Health and Social Security* Disposable Hypodermic and Allied Equipment Manufacturers Associati

5、on Medical Defence Union Medical Protection Society Medical Sterile Products Association Ministry of Agriculture, Fisheries and Food Ministry of Defence* Queens Institute of District Nursing* Royal College of Midwives* Royal College of Obstetricians and Gynaecologists* Royal College of Surgeons of E

6、dinburgh* Royal College of Veterinary Surgeons Royal Institute of Public Health and Hygiene Scientific Instrument Manufacturers Association of Great Britain The organizations marked with an asterisk in the above list, together with the following, were directly represented on the committee entrusted

7、with the preparation of this British Standard: Association of Sterile Supply Administrators British Aluminium Holloware Manufacturers Association British Paper Box Association British Plastics Federation Institute of Purchasing and Supply Royal College of Nursing and National Council of Nurses of th

8、e UK Royal College of Physicians of London Stainless Steel Fabricators Association Amendments issued since publication Amd. No. Date of issue CommentsBS5452:1977 BSI 11-1999 i Contents Page Cooperating organizations Inside front cover Foreword ii 1 Scope 1 2 References 1 3 Dimensions 1 4 Materials 1

9、 5 Design 1 6 Freedom from toxicity 2 7 Finish and workmanship 2 8 Covers 2 9 Impact resistance 2 10 Effect of sterilization 2 11 Resistance to handling under load 2 12 Marking 2 Appendix A Method of test for sterilization 4 Appendix B Method of test under load 4 Figure 1 Rectangular instrument tray

10、 5 Figure 2 Typical compartmented instrument tray 6 Figure 3 Kidney dish 7 Figure 4 Typical wash bowl 8 Figure 5 Lotion bowls 8 Figure 6 Gallipots 9 Figure 7 Jugs 9 Figure 8 The “envelope” fold 10 Table 1 Dimensions of plastics hollow-ware 3 Publications referred to Inside back coverBS5452:1977 ii B

11、SI 11-1999 Foreword This British Standard was prepared at the request of the British Plastics Federation and authorized by the Surgical Instrument and Medical Appliances Standards Committee of BSI. The standard has been prepared to establish acceptance standards for plastics hollow-ware for use in h

12、ospitals and other health service areas. Requirements for quality and finish are laid down to ensure that articles give a satisfactory performance for their stated use within the range of this specification. BS1823 deals with stainless steel hollow-ware for use in hospital operating theatres and war

13、ds. At elevated temperatures, plastics material may suffer deformation under stress and care should be taken in the packaging of the articles and in the loading of them into the sterilization chamber. When flammable anaesthetics are used, hollow-ware from plastics materials capable of generating and

14、 retaining electrostatic surface charges should not be brought within0.25m of any part of an anaesthetic breathing circuit. 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

15、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 to10, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had ame

16、ndments incorporated. This will be indicated in the amendment table on the inside front cover.BS5452:1977 BSI 11-1999 1 1 Scope This British Standard specifies requirements for hospital hollow-ware made of plastics materials. Provision is made for the following nominal sizes: 2 References The titles

17、 of the publications referred to in this standard are listed on the inside back cover. 3 Dimensions The dimensions of each plastics utensil (excluding jugs) shall be as given inTable 1. 4 Materials The hollow-ware shall be made from suitable plastics material, which shall comply with the requirement

18、s of clauses10 and11. 5 Design 5.1 General 5.1.1 The design shall be such as to prevent utensils from jamming together if stacked. 5.1.2 The base shall be designed to prevent suction on flat surfaces and to allow for drainage in the inverted position. 5.2 Rectangular instrument trays 5.2.1 Size desi

19、gnation. The size of rectangular instrument trays shall be designated by the nominal internal length and nominal internal width as shown inTable 1 andFigure 1. 5.2.2 Size range. The range of sizes shall be as given inTable 1. 5.2.3 Design. The design and dimensions of rectangular instrument trays sh

20、all be in accordance withFigure 1 andTable 1. 5.3 Compartmented instrument tray 5.3.1 Size. The size of the compartmented instrument tray shall be designated by the nominal overall dimensions as shown inTable 1 and Figure 2. 5.3.2 Design. The design and dimensions of the compartmented instrument tra

21、y shall generally be in accordance withFigure 2. The tray shall have four compartments. 5.4 Kidney dishes 5.4.1 Size designation. The size of kidney dishes shall be designated by the nominal length between the rim centres as shown inTable 1 andFigure 3. 5.4.2 Size range. The range of sizes of kidney

22、 dishes shall be as given inTable 1. 5.4.3 Design. The design and dimensions of kidney dishes shall be in accordance withFigure 3 andTable 1. 5.5 Wash bowl 5.5.1 Size. The size of the wash bowl shall be as given inTable 1 and illustrated inFigure 4. 5.5.2 Design. The design and dimensions of the was

23、h bowl shall be in accordance withFigure 4 andTable 1. 5.6 Lotion bowls 5.6.1 Size designation. The size of lotion bowls shall be designated by the nominal internal diameter as shown inTable 1 andFigure 5. 5.6.2 Size range. The range of sizes of lotion bowls shall be as given inTable 1. 5.6.3 Design

24、. The design and dimensions of lotion bowls shall be in accordance withFigure 5 andTable 1. 5.7 Gallipots 5.7.1 Size designation. The size of gallipots shall be designated by the nominal internal diameter and nominal capacity as shown inTable 1 andFigure 6. 5.7.2 Size range. The range of sizes of ga

25、llipots shall be as given inTable 1. 5.7.3 Design. The design, dimensions and capacities of gallipots shall be in accordance withFigure 6 andTable 1. instrument trays 200mm 150mm 50mm 300mm 250mm 50mm compartmented instrument tray 270mm 180mm 40mm kidney dishes 150mm 200mm 250mm 300mm wash bowl 350m

26、m 135mm lotion bowls 100mm 45mm 150mm 65mm 200mm 90mm 250mm 110mm gallipots 40mm 30ml to60ml 60mm 90ml to120ml 80mm 250ml to280ml measuring jugs 500ml capacity 1000ml capacityBS5452:1977 2 BSI 11-1999 5.8 Measuring jugs 5.8.1 General. There shall be two sizes of graduated measuring jugs, namely500ml

27、 and1000ml capacity, corresponding to the top graduation mark. To minimize the risk of spillage in use, there shall be sufficient ungraduated depth at the top of the jug. 5.8.2 Marking of capacity. Jugs shall be graduated externally in50ml increments. The width of the graduation lines shall not exce

28、ed1mm. The accuracy of graduation of the scale shall be such that the actual volume corresponding to each graduation mark shall be within a tolerance of 5% of the indicated volume. 5.8.3 Shape and dimensions 5.8.3.1 Cross section. Measuring jugs shall be of circular cross section with the sides tape

29、ring towards the base, such that the slope lies between0.5 and9 as shown inFigure 7. 5.8.3.2 Stability. The ratio of the height, B, of the jug to its base diameter, A, shall not exceed2 : 1 as indicated inFigure 7. 5.8.3.3 Rim. If desired, the rim of the measuring jug may be provided with an outer r

30、einforcing ring integral with the body of the jug. An internal reinforcing ring shall not be used. 5.8.3.4 Handles. Handles of adequate strength shall be provided so that the jug is safe in use. 5.8.3.5 Lip. Any pouring lip provided shall lie wholly above the graduated portion of the jug and shall b

31、e “non-drip” in normal use. 6 Freedom from toxicity The plastics hollow-ware, including colourants used in the plastics, shall not liberate substances likely to produce toxic effects in conditions of normal use. 7 Finish and workmanship The surface shall be smooth, with minimum flash, and the articl

32、e shall be free from moulding defects causing surface irregularities. 8 Covers Covers to vessels are optional. If required for instrument trays, kidney dishes, lotion bowls, gallipots and jugs, the covers shall be of such a size and shape that they fit the relevant vessel. The sizes of the covers sh

33、all be such that they are made to correspond to the maximum tolerances of the vessels that are to fit. The covers shall be designed with an integral rim so that they shall be retained in place when the relevant vessel is tilted in any direction to an angle of60 from the horizontal. Covers should be

34、produced with a suitable handle. The material of construction, the finish and the workmanship shall comply with the requirements of clauses4, 6, 7, 9 and10. 9 Impact resistance At room temperature(20 5 C) the article shall be capable of withstanding a free fall from a height of1.25m onto a concrete

35、or similar hard surface without breaking. A test shall be carried out on the article both before and after testing in accordance with clause10. 10 Effect of sterilization When tested by the method specified inAppendix A there shall be no deterioration of the shape, finish or strength, or graduation

36、marks where applicable, such as to affect the use of the hollow-ware. If the hollow-ware is coloured, the colour shall not visibly change nor shall there be any transference of colour to the sterilization paper. 11 Resistance to handling under load When tested by the method specified inAppendix B, t

37、here shall be no loss of contents from the hollow-ware. 12 Marking Each article shall be plainly and permanently marked on the under-surface with the following: a) the name, trade mark or identification of the manufacturer; b) the number of this British Standard, i.e.BS5452; c) information regarding

38、 type and size, i.e.LB100 (lotion bowl100mm).BS5452:1977 BSI 11-1999 3 Table 1 Dimensions of plastics hollow-ware Item Nominal size Internal length, L Internal width, W Length between rim centres, L c Internal depth, D Internal diameter mm mm mm mm mm mm Instrument trays 200 150 300 250 at top at bo

39、ttom at top at bottom 200 2 182 2 305 2 290 2 at top at bottom at top at bottom 150 2 132 2 255 2 238 2 50 2 50 2 Compartmented instrument trays 270 180 40 2 Kidney dishes 150 200 250 300 152 2 203 2 254 2 305 2 Wash bowl 350 135 135 2 Lotion bowls 100 45 150 65 200 90 250 110 45.0 2 67.0 2 89.0 2 1

40、12 2 102 2 152 2 203 2 254 2 Gallipots 40(30ml to60ml) 60(90ml to120ml) 80(250ml to280ml) 41.0 2 57.0 2 83.0 2BS5452:1977 4 BSI 11-1999 Appendix A Method of test for sterilization Each piece of hollow-ware shall be wrapped in sterilization paper using the “envelope” fold (seeFigure 8) and sealed wit

41、hin a sterilization bag. Paper and bags used shall be of approved quality for steam sterilization. Each package shall be subjected to50 sterilization cycles in a sterilizer operating at134+4, 0 C in accordance with BS3970-1. During the tests the articles shall not be otherwise stressed or loaded. Ap

42、pendix B Method of test under load Each piece of hollow-ware, sterilized as specified inAppendix A, shall be stood upon a flat surface and filled to75% of the brimful capacity with water at20 5 C. The hollow-ware shall be lifted vertically from the surface and held for10s. Jugs shall be held by the

43、handle. Other hollow-ware shall be gripped in either Cheatles forceps (complying with the requirements of BS2905) or Harrisons bowl forceps (complying with the requirements of BS3204), as appropriate, so that the jaws face downwards over the rim of the article. For the wash bowl and large instrument

44、 tray, two forceps shall be used, one on each of the opposing sides. BS5452:1977 BSI 11-1999 5 Designated length Dimensions( 2mm) A L C B W F D 200 208 200 182 159 150 132 50 300 314 305 290 264 255 238 50 Figure 1 Rectangular instrument trayBS5452:1977 6 BSI 11-1999 Figure 2 Typical compartmented i

45、nstrument trayBS5452:1977 BSI 11-1999 7 Figure 3 Kidney dishBS5452:1977 8 BSI 11-1999 Figure 4 Typical wash bowl Figure 5 Lotion bowlsBS5452:1977 BSI 11-1999 9 Figure 6 Gallipots Figure 7 JugsBS5452:1977 10 BSI 11-1999 Figure 8 The “envelope” foldBS5452:1977 BSI 11-1999 Publications referred to BS18

46、23, Stainless steel hollow-ware for use in hospital operating-theatres and wards. BS2905, Cheatles sterilizer forceps (light and heavy patterns). BS3204, Harrisons bowl forceps. BS3970, Steam sterilizers. BS3970-1, Sterilizers for porous loads. BS5452:1977 BSI 389 Chiswick High Road London W4 4AL BS

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