BS 4272-1-1968 Anaesthetic and analgesic machines - Anaesthetic machines of the on-demand type supplied with nitrous oxide and oxygen from separate containers《麻醉机和止痛机 由专门容器分别供给氧化亚氮.pdf

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1、BRITISH STANDARD BS 4272-1: 1968 Specification for Anaesthetic and analgesic machines Part 1: Anaesthetic machines of the on-demand type supplied with nitrous oxide and oxygen from separate containersBS4272-1:1968 This British Standard, having been approved by the Surgical Instruments and Medical Ap

2、pliances Industry Standards Committee and endorsed by the Chairman of the Chemical Divisional Council, was publishedunder the authority ofthe General Council on 15 January 1968 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference SGC/15/4 Draft for commen

3、t 66/29852 ISBN 580 00004 4 Co-operating organizations The Surgical Instruments and Medical Appliances Standards Committee, under whose supervision this British Standard was prepared, consists of representatives from the following Government departments and professional and industrial organizations:

4、 Association of Hospital Matrons British Dental Association British Medical Association British Surgical Trades Association, Inc.* Federation of British Rubber and Allied Manufacturers* Institute of British Surgical Technicians Medical Defence Union* Medical and Dental Defence Union of Scotland* Med

5、ical Protection Society Ministry of Agriculture, Fisheries and Food Ministry of Defence, Air Force Department* Ministry of Defence, Army Department* Ministry of Defence, Navy Department* Ministry of Health* Queens Institute of District Nursing Royal College of Midwives Royal College of Nursing* Roya

6、l College of Obstetricians and Gynaecologists Royal College of Physicians and Surgeons of Glasgow Royal College of Physicians of London Royal College of Surgeons of Edinburgh Royal College of Surgeons of England* Royal College of Veterinary Surgeons Royal Institute of Public Health & Hygiene The Gov

7、ernment departments and professional and industrial organizations marked with an asterisk in the above list, together with the following, were directly represented on the committee entrusted with the preparation of this British Standard: Association of Anaesthetists of Great Britain & Ireland Britis

8、h Mechanical Rubber Manufacturers Association British Plastics Federation Central Midwives Board Faculty of Anaesthetists of The Royal College of Surgeons World Federation of Societies of Anaesthesiologists Individual manufacturers Amendments issued since publication Amd. No. Date CommentsBS4272-1:1

9、968 BSI 10-1999 i Contents Page Co-operating organizations Inside front cover Foreword ii 1 Scope 1 2 Range of gas mixture control 1 3 Material 1 4 Design 1 5 Antistatic requirements 1 6 Gas mixture control 1 7 Resistance to inspiratory flow 2 8 Safety cut-out 2 9 Emergency oxygen supply 2 10 Connec

10、tions for medical gas cylinders 2 11 Connection with centralized pipeline services 3 12 Delivery outlet from the anaesthetic machine 3 13 Marking 3 Appendix A Determination of the oxygen content of the gas mixturedeliveredbythe anaesthetic machine 4 Appendix B Recommendations for periodic field test

11、ing of apparatus 4 Table 1 Accuracy of scale reading for oxygen 2BS4272-1:1968 ii BSI 10-1999 Foreword This standard makes reference to the following British Standards: BS 1319, Medical gas cylinders and anaesthetic apparatus. BS 2050, Electrical resistance of conductive and antistatic products made

12、 from flexible polymeric material. BS 3849, Breathing attachments for anaesthetic apparatus. The preparation of Part 1 of this British Standard was requested by the Ministry of Health, and authorized by the Surgical Instruments and Medical Appliances Industry Standards Committee of the BSI. The spec

13、ification covers the design and performance requirements for an apparatus operating on the “patient demand” principle for use primarily in dentistry and midwifery. It is confined to apparatus for supplying mixtures of nitrous oxide and oxygen wherein the two gases are supplied independently from sep

14、arate cylinders or pipelines and mixing takes place within the apparatus. Depending upon the application, apparatus of this type may be required in a form to give one mixture which cannot be altered by the user. Alternatively it may be required in a form capable of permitting the operator to vary th

15、e composition of the mixture over the range of 100 % oxygen to 100 % nitrous oxide, or over a predetermined portion of this range. For some applications, especially in dentistry, it is necessary to supply the gas to the patient at atmospheric pressure (intermittent flow) or positive pressure (interm

16、ittent or continuous flow). In such cases, it is necessary also to be able to vary this pressure between zero (“patient demand”) and a maximum, usually about 30 cmH 2 O. The specified performance of the machine applies at the normal outlet of the machine and takes no account of accessories such as v

17、aporizers and breathing attachments, including the expiratory valve. Other British Standards dealing with anaesthetic and related equipment include the following: BS 1263, Hypodermic syringes for use in medical and surgical practice. BS 1319, Medical gas cylinders and anaesthetic apparatus. BS 2463,

18、 Transfusion equipment for medical use. BS 2743, Sphygmomanometers. Aneroid type. BS 2744, Sphygmomanometers. Mercury type. BS 2927, Anaesthetic airways. BS 3353, Anaesthetic breathing bags made of anti-static rubber. BS 3487, Endotracheal tubes. BS 3522, Hypodermic surgical mounted needles (Luer fi

19、tting). BS 3806, Breathing machines for medical use. BS 3849, Breathing attachments for anaesthetic apparatus. BS 3930, Conical fitting with 6 per cent (Luer) taper for hypodermic and other surgical equipment. BS 4272, Anaesthetic and analgesic machines Part 2: Analgesic machines of the on-demand ty

20、pe supplied with pre-mixed nitrous oxide-oxygen from a single container. BS4272-1:1968 BSI 10-1999 iii 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 Standa

21、rd 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 to5 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated

22、in the amendment table on the inside front cover.iv blankBS4272-1:1968 BSI 10-1999 1 1 Scope Part 1 of this British Standard specifies basic requirements primarily from the standpoint of performance and safety, for anaesthetic machines of the on-demand type supplied with nitrous oxide and oxygen fro

23、m separate containers, as used in dentistry and midwifery. Appendix B gives recommendations for periodic field testing of apparatus. NOTEBS 4272-2 deals with analgesic machines of the on-demand type supplied with premixed nitrous oxide and oxygen from a single container. 2 Range of gas mixture contr

24、ol Depending upon the application, the anaesthetic machine shall supply medical gases under all conditions of pressure and rate of flow in accordance with one of the following: 1) A fixed mixture of nitrous oxide and oxygen. 2) A mixture of nitrous oxide and oxygen which permits the operator to vary

25、 the composition over the range of 0 % to 100 % oxygen and correspondingly for nitrous oxide. 3) A mixture of nitrous oxide and oxygen which may be varied in composition over a restricted range from say 20 % to 100 % oxygen and correspondingly for nitrous oxide. The equipment shall be so designed th

26、at when the controls are set to give any particular gas mixture (where applicable), and under conditions of varying flow, the performance of the apparatus will satisfy the requirements of 6.7. 3 Material 3.1 Where possible, materials shall be corrosion resisting. If this is not practicable, and espe

27、cially where corrosion products can adversely affect the performance of the apparatus, the components in question shall be electroplated or otherwise protected to give a corrosion resisting surface. 3.2 Materials and finishes shall suffer no deleterious effects arising from accidental spillage of li

28、quid anaesthetic agents, antiseptics, etc., or be capable of introducing any obnoxious odour or other undesirable products into the inhaled gas stream. 4 Design 4.1 Construction. The construction of the apparatus shall be mechanically sound and robust and shall be capable of continuous operation for

29、 sustained periods. 4.2 Controls. The equipment shall be arranged to give clear visibility and ease of operation of all controls. 5 Antistatic requirements The components forming the gas circuit shall be so designed that there is no possibility of a potentially hazardous electrostatic charge being p

30、roduced. Such components made of rubber or other elastomeric material shall be in accordance with BS2050 1) , except that small components (e.g.flowmeter tubes) necessarily made of an electrically insulating material, or components completely enclosed by conducting material and supported in such a w

31、ay that the generation of any significant electrostatic charge is precluded, shall be permitted provided that an electrically conducting path is otherwise maintained between their ends. In addition to the body structure of the components forming part of the gas circuit, surface coatings, ifany, shal

32、l not be capable of retaining any significant electrostatic charge and such surface coatings shall not prevent the discharge of static electricity between component parts of the gas circuit. 6 Gas mixture control 6.1 Gas mixture scale. The gas mixture scale shall clearly show the percentage by volum

33、e of oxygen in the nitrous oxide-oxygen mixture. 6.2 Limits of accuracy of gas mixture control. The limits of accuracy of the gas mixture, tested in accordance with Appendix A, shall be in accordance with Table 1. These limits of accuracy shall apply to all combinations of respiratory rate and tidal

34、 volume, within the specified range of minute volumes, in accordance with the following: Respiratory rate:8 to 35 cycles per minute Tidal volume:250 ml to 1 000 ml 6.3 Consistency of gas mixture. The apparatus shall be capable of satisfying a type test for a fixed period of not less than 1 hour with

35、 the pump set to a rate of 20 cycles per minute and a displacement volume of 600 ml. At the end of this period, the accuracy of the mixture shall remain within the limits specified in Table 1, when tested in accordance with Appendix A. 1) BS 2050, “Electrical resistance of conductive and anti-static

36、 products made from flexible polymeric material”.BS4272-1:1968 2 BSI 10-1999 Table 1 Accuracy of scale reading for oxygen 6.4 Pressure control valve. When a pressure control valve is provided it shall be clearly marked to indicate when the free discharge to atmosphere is not less than 20 litres per

37、minute. A flow meter having a low resistance shall be used to determine the flow rate. 6.5 Pressure breathing. If provision is made for the apparatus to supply gas to the patient under pressure, the limits of accuracy of the gas mixture over the whole range of pressures shall be in accordance with T

38、able 1. 6.6 Effect of temperature. The apparatus shall be capable of satisfying a type test over an ambient temperature range of 10 C to 32 C with the pump set to a displacement volume of 600 ml and a rate of20 cycles per minute. Adequate time shall be allowed for temperature equalization throughout

39、 the machine. The accuracy of the mixture shall remain within the specified limits of Table 1, when tested in accordance with Appendix A. 6.7 Effect of variation of supply pressure. The specified requirements for delivery and resistance to gaseous flow shall apply under supply pressure variations do

40、wn to 13.8 bar (14 kgf/cm 2 ) 2)for apparatus operating direct from cylinders or at3.45bar (3.5 kgf/cm 2 ) 3)for apparatus designed to operate from piped gas supply. 7 Resistance to inspiratory flow The resistance to gaseous flow on inspiratory demand of the apparatus, measured with a continuous flo

41、w of a gas mixture containing 50 % v/v of oxygen, shall not exceed: 1) 30 mmH 2 O (2.96 mb) at a flow rate of 20 litres/min. 2) 80 mmH 2 O (7.90 mb) at a flow rate of 160 litres/min. In the case of apparatus which incorporates a pressure control valve, it shall be set in the zero (demand) position.

42、8 Safety cut-out A safety device shall be fitted in the gas circuits to cut off the supply of nitrous oxide to the patient should the oxygen supply fail and an air inspiratory valve shall be incorporated which will automatically allow the patient to breathe air in the event of failure of the oxygen

43、supply. 9 Emergency oxygen supply When an emergency oxygen supply is fitted a relief valve shall be incorporated to prevent the pressure exceeding 500 mmH 2 O (49 mbar) 4) . The flow of the emergency oxygen supply with the valve fully open shall be not less than 35 litres per minute. The emergency o

44、xygen shall be delivered by by-passing the gas mixture control mechanism. NOTEEmergency oxygen supply is normally obtained from the oxygen cylinder connected to the anaesthetic machine and consequently oxygen for emergency purposes will not be available if the oxygen cylinder is permitted to become

45、empty. 10 Connections for medical gas cylinders 10.1 For apparatus designed to operate direct from medical gas cylinders, the connections to the cylinders shall be non-interchangeable and in accordance with BS 1319 5) . 10.2 A contents gauge for the oxygen cylinder shall be provided with the scale m

46、arked “0, !, “, #, full”. The segment 0 to ! shall be coloured red. Indicated oxygen percentage Tolerance on oxygen content of gases delivered by the machine (expressedaspercentage by volume) Minute volume (litres) 4 to 7“ Over 7“ to 20 Over 20 to 30 0 10 + 5 3 + 2 1 + 5 3 over 10 20 5 2 5 over 20 5

47、0 5 + 5 3 5 over 50 1 000 5 5 5 2) Approximately equivalent to 200 lbf/in 2 . 3) Approximately equivalent to 50 lbf/in 2 . 4) Approximately equivalent to 0.71 lbf/in 2 . 5) BS 1319, “Medical gas cylinders and anaesthetic apparatus”.BS4272-1:1968 BSI 10-1999 3 11 Connection with centralized pipeline

48、services For apparatus designed to operate from centralized pipeline services, connections shall be non-interchangeable and in accordance with BS . . . . 6) . 12 Delivery outlet from the anaesthetic machine The delivery outlet of the anaesthetic machine shall have a male conical fitting of nominal 2

49、2 mm diameter in accordance with BS 3849 7) . NOTEThe conical fitting at the delivery end of the anaesthetic machine is designed for use with breathing attachments in accordance with BS 3849 7) . 13 Marking The equipment shall be clearly marked with the following: 1) The name or trade mark of the manufacturer. 2) The number of this British Standard, i.e. BS 4272-1. The relevant controls shall be marked as follows: “OXYGEN PERCENTAGE” “PRESSURE” “EMERGENCY OXYGEN” NOTEThe mark BS 4272-1 on or in relation to the product is a claim by th