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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 containers Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 30 07:04:19 GMT+00:00 2006, Uncontrolled Copy,
2、(c) BSI BS 4272-1:1968 This British Standard, having been approved by the Surgical Instruments and Medical Appliances Industry Standards Committee and endorsed by the Chairman of the Chemical Divisional Council, was published under the authority of the General Council on 15 January 1968 BSI 10-1999
3、The following BSI references relate to the work on this standard: Committee reference SGC/15/4 Draft for comment 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, consi
4、sts of representatives from the following Government departments and professional and industrial organizations: Association of Hospital Matrons British Dental Association British Medical Association British Surgical Trades Association, Inc.* Federation of British Rubber and Allied Manufacturers* Ins
5、titute of British Surgical Technicians Medical Defence Union* Medical and Dental Defence Union of Scotland* Medical Protection Society Ministry of Agriculture, Fisheries and Food Ministry of Defence, Air Force Department* Ministry of Defence, Army Department* Ministry of Defence, Navy Department* Mi
6、nistry of Health* Queens Institute of District Nursing Royal College of Midwives Royal College of Nursing* Royal 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
7、of Surgeons of England* Royal College of Veterinary Surgeons Royal Institute of Public Health & Hygiene The Government departments and professional and industrial organizations marked with an asterisk in the above list, together with the following, were directly represented on the committee entruste
8、d with the preparation of this British Standard: Association of Anaesthetists of Great Britain & Ireland British Mechanical Rubber Manufacturers Association British Plastics Federation Central Midwives Board Faculty of Anaesthetists of The Royal College of Surgeons World Federation of Societies of A
9、naesthesiologists Individual manufacturers Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 30 07:04:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 4272-1:1968 BSI 10-1999i Contents Page Co-operating organizationsInside front cover Forewo
10、rdii 1Scope1 2Range of gas mixture control1 3Material1 4Design1 5Antistatic requirements1 6Gas mixture control1 7Resistance to inspiratory flow2 8Safety cut-out2 9Emergency oxygen supply2 10Connections for medical gas cylinders2 11Connection with centralized pipeline services3 12Delivery outlet from
11、 the anaesthetic machine3 13Marking3 Appendix A Determination of the oxygen content of the gas mixture delivered by the anaesthetic machine4 Appendix B Recommendations for periodic field testing of apparatus4 Table 1 Accuracy of scale reading for oxygen2 Licensed Copy: sheffieldun sheffieldun, na, T
12、hu Nov 30 07:04:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 4272-1:1968 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 f
13、rom 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 specif
14、ication 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 separ
15、ate 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 the
16、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 (intermit
17、tent 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 cmH2O. The specified performance of the machine applies at the normal outlet of the machine and takes no account of accessories such as vapor
18、izers 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, Tra
19、nsfusion 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 fittin
20、g). 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 type s
21、upplied with pre-mixed nitrous oxide-oxygen from a single container. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 30 07:04:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 4272-1:1968 BSI 10-1999iii A British Standard does not purport to include all the necessary provisions of a contract. Use
22、rs of British Standards are responsible for their correct application. 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, pages i to iv, pages 1 to 5 and a back cover. This stand
23、ard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 30 07:04:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun
24、sheffieldun, na, Thu Nov 30 07:04:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 4272-1:1968 BSI 10-19991 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 nitro
25、us oxide and oxygen from 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 Ran
26、ge of gas mixture control 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 permi
27、ts the operator to vary 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
28、shall be so designed that 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 no
29、t practicable, and especially 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 ac
30、cidental spillage of liquid 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 c
31、ontinuous operation for 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 elect
32、rostatic charge being produced. Such components made of rubber or other elastomeric material shall be in accordance with BS 20501), except that small components (e.g. flowmeter tubes) necessarily made of an electrically insulating material, or components completely enclosed by conducting material an
33、d supported in such a way 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, surfac
34、e coatings, if any, shall 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
35、 the percentage by volume 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 re
36、spiratory rate and tidal 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 n
37、ot less than 1 hour with 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 co
38、nductive and anti-static products made from flexible polymeric material”. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 30 07:04:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 4272-1:1968 2 BSI 10-1999 Table 1 Accuracy of scale reading for oxygen 6.4 Pressure control valve. When a pressure c
39、ontrol valve is provided it shall be clearly marked to indicate when the free discharge to atmosphere is not less than 20 litres per 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
40、the patient under pressure, the limits of accuracy of the gas mixture over the whole range of pressures shall be in accordance with Table 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 di
41、splacement volume of 600 ml and a rate of 20 cycles per minute. Adequate time shall be allowed for temperature equalization throughout 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 s
42、upply pressure. The specified requirements for delivery and resistance to gaseous flow shall apply under supply pressure variations down to 13.8 bar (14 kgf/cm2) 2) for apparatus operating direct from cylinders or at 3.45 bar (3.5 kgf/cm2) 3) for apparatus designed to operate from piped gas supply.
43、7 Resistance to inspiratory flow The resistance to gaseous flow on inspiratory demand of the apparatus, measured with a continuous flow of a gas mixture containing 50 % v/v of oxygen, shall not exceed: 1) 30 mmH2O (2.96 mb) at a flow rate of 20 litres/min. 2) 80 mmH2O (7.90 mb) at a flow rate of 160
44、 litres/min. In the case of apparatus which incorporates a pressure control valve, it shall be set in the zero (demand) position. 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 inspir
45、atory valve shall be incorporated which will automatically allow the patient to breathe air in the event of failure of the oxygen supply. 9 Emergency oxygen supply When an emergency oxygen supply is fitted a relief valve shall be incorporated to prevent the pressure exceeding 500 mmH2O (49 mbar)4).
46、The flow of the emergency oxygen supply with the valve fully open shall be not less than 35 litres per minute. The emergency oxygen shall be delivered by by-passing the gas mixture control mechanism. NOTEEmergency oxygen supply is normally obtained from the oxygen cylinder connected to the anaesthet
47、ic machine and consequently oxygen for emergency purposes will not be available if the oxygen cylinder is permitted to become 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-interc
48、hangeable and in accordance with BS 13195). 10.2 A contents gauge for the oxygen cylinder shall be provided with the scale marked “0, !, “, #, full”. The segment 0 to ! shall be coloured red. Indicated oxygen percentage Tolerance on oxygen content of gases delivered by the machine (expressed as perc
49、entage by volume) Minute volume (litres) 4 to 7“Over 7“ to 20Over 20 to 30 0 10+ 5 3+ 2 1+ 5 3 over 10 20 5 2 5 over 20 50 5+ 5 3 5 over 50 1 000 5 5 5 2) Approximately equivalent to 200 lbf/in2. 3) Approximately equivalent to 50 lbf/in2. 4) Approximately equivalent to 0.71 lbf/in2. 5) BS 1319, “Medical gas cylinders and anaesthetic apparatus”. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 30 07:04:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 4272-1:1968 BSI 10-19993 11 Connection with centralized pipeline services For apparatus desig