BS 4272-2-1996 Anaesthetic and analgesic machines - Specification for intermittent (demand) flow analgesic machines for use with 50 50% (V V) nitrous oxide and oxygen《麻醉机和止痛机 使用50 .pdf

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1、BRITISH STANDARD BS 4272-2:1996 Incorporating Amendment No. 1 Anaesthetic and analgesic machines Part 2: Specification for intermittent (demand) flow analgesic machines for use with 50/50 % (V/V) nitrous oxide and oxygen UDC 615.471:616-089.5 BS 4272-2:1996 This British Standard, having been prepare

2、d under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 February 1996 BSI 14 January 2003 First published January 1968 Second edition January 1996 The following BSI references relate to the work on this st

3、andard: Committee reference CH/121/1 Draft for comment 92/59246 DC ISBN 0 580 24776 7 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/121/1, Anaesthetic machines, breathing systems and anaesthetic gas scavenging system

4、s, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of British Health-care Industries British Anaesthetic and Respiratory Equipment Manufacturers Association Department of Health Medical Sterile Products Association The following

5、 body was also, represented in the drafting of the standard, through subcommittees and panels: Guild of Hospital Pharmacists Amendments issued since publication Amd. No. Date Comments 13963 14 January 2003 See national forewordBS 4272-2:1996 BSI 14 January 2003 i Contents Page Committees responsible

6、 Inside front cover Foreword ii 1S c o p e 1 2 Normative references 1 3 Definitions 1 4M a t e r i a l s 2 5 Resistance to mechanical hazards 2 6 Legibility of marking on controls 2 7 Performance after cleaning and sterilization or disinfection 2 8 Connections for gas supply 2 9 Patient connection p

7、ort 3 10 Exhaust port 3 11 Resistance to environmental conditions 4 12 Performance 4 13 Additional requirements for portable analgesic machines 4 14 Marking 5 15 Instructions for use 5 Annex A (normative) Test methods 6 Figure 1 Symbol for “use no oil” 2 Figure A.1 Apparatus for measuring inspirator

8、y flow and differential pressure 8 Figure A.2 Apparatus for measuring expiratory resistance 9 List of references 11BS 4272-2:1996 ii BSI 14 January 2003 Foreword This Part of BS 4272 has been prepared by Technical Committee CH/121/1. It supersedes BS 4272-2:1968, which is withdrawn. The start and fi

9、nish of text introduced or altered by Amendment No. 1 is indicated in the text by tags . Since BS 4272-2:1968 was published, the use of analgesic machines of this type has been extended to emergency situations and to medical fields other than the original application in midwifery. The major differen

10、ces between this standard and BS 4272-2:1968 are as follows. a) Requirements related to the safety of high-pressure components have been added. b) Requirements related to mechanical construction have been added, with particular relevance to the use of the equipment in emergency situations. c) The re

11、quirements for the gas supply connection, pertaining to compatibility with anaesthetic and respiratory equipment specified in other British Standards, have been clarified. d) The test methods have been modified so that they are consistent with those in other British Standards for anaesthetic and res

12、piratory equipment. e) The requirements for marking and instructions have been aligned with the Essential Requirements of the EEC Directive for Medical Devices. f) The pressure/flow characteristics of the demand valve have been reconsidered. Whilst there have been no reports of hazards to the patien

13、t resulting from the previous peak flow of 300 l/min, evidence was presented to the committee responsible for this standard that rapid response to inspiratory effort may be as significant as the peak flow capability in satisfying the respiratory needs of the patient, and a lower peak flow may theref

14、ore be acceptable. Analgesic machines based on this premise have been in use without report of hazards. The other Parts of BS 4272 are as follows: BS 4272, Anaesthetic and analgesic machines Part 1:1968 Anaesthetic machines of the on-demand type supplied with nitrous oxide and oxygen from separate c

15、ontainers; Part 3:1989 Specification for continuous flow anaesthetic machines. Part 1 and Part 3 of BS 4272 were declared obsolescent following review in 1991 and 2001 respectively. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its

16、 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 and ii, pages 1 to 11 and a back cover. The BSI copyright notice displayed in this document indic

17、ates when the document was last issued.BS 4272-2:1996 BSI 14 January 2003 1 1 Scope This Part of BS 4272 specifies general design and performance requirements for analgesic machines of the intermittent flow (demand flow) type for use with 50/50 % (V/V) mixture of oxygen and nitrous oxide contained i

18、n one cylinder, (hereinafter referred to as “analgesic machines”). This standard applies to analgesic machines intended for: a) connection directly to a high-pressure (approximately 17 MPa) cylinder; and b) connection to a low-pressure (280 kPa to 600 kPa) supply from a medical gas pipeline system,

19、or a similar source, filled from cylinder(s). Additional requirements for portable machines are included. This standard applies to analgesic machines which are intended to be used under supervision for the self-administration of an analgesic mixture in response to the patients inspiratory effort, e.

20、g. in obstetric practice or in emergency situations. It does not apply to analgesic machines with means to initiate gas flow other than by the patients inspiratory effort. This standard does not give requirements for the composition of the gas mixture, or for the markings on the gas cylinder. NOTE T

21、he gas is pre-mixed and specified in pharmacopoeia monographs. The markings on the gas cylinder are specified in BS EN 850 . 2 Normative references This Part of BS 4272 incorporates, by dated or undated reference, provisions from other publications. These normative references are made at the appropr

22、iate places in the text and the cited publications are listed on page 11. For dated references, only the edition cited applies; any subsequent amendments to or revisions of the cited publication apply to this Part of BS 4272 only when incorporated in the reference by amendment or revision. For undat

23、ed references, the latest edition of the cited publication applies, together with any amendments. 3 Definitions For the purposes of this Part of BS 4272, the definitions in BS EN ISO 4135 apply, together with the following. 3.1 intermittent flow analgesic machine; demand flow analgesic machine analg

24、esic machine which, in response to the patients inspiratory effort, delivers a flow of gas which ceases at the start of the expiratory phase 3.2 direct probe probe that has either the nut and nipple of a non-interchangeable screw-threaded (NIST) connector as integral parts, or is directly coupled to

25、 an item of medical equipment to form a single functional unit which is not intended to be dismantled, except for servicing 3.3 remote probe probe connected to equipment by means of an intermediate hose, the hose insert being an integral part of the probe 3.4 demand valve gas flow valve which opens

26、only while a sub-atmospheric pressure exceeding a predetermined level is applied to its outletBS 4272-2:1996 2 BSI 14 January 2003 4 Materials NOTE Materials which are in contact with nitrous oxide-oxygen 50/50 % (V/V) should be: a) compatible with oxygen and nitrous oxide; b) resistant to leaching

27、by these gases. 5 Resistance to mechanical hazards The analgesic machine shall conform to clause 12 after the components which are intended to be held by the patient when the machine is in use have been dropped in accordance with A.2. 6 Legibility of marking on controls All markings pertaining to th

28、e operation of the analgesic machine shall be legible to an operator having visual acuity, corrected if necessary, of at least 1.0, from the operating position of the apparatus, under an illuminance of 215 lx. 7 Performance after cleaning and sterilization or disinfection The analgesic machine shall

29、 conform to clause 12 after the reusable parts which come into contact with the patient or the patients exhaled gases have been subjected to 20 cycles of the cleaning and sterilization or disinfection processes stated by the manufacturer. See 15 f). 8 Connections for gas supply 8.1 Analgesic machine

30、 for connection to a cylinder 8.1.1 Cylinder yoke The connecting yoke for a cylinder of pre-mixed nitrous oxide-oxygen 50/50 % (V/V) shall conform to BS EN 850 , and shall form the inlet of the pressure regulator. 8.1.2 Filter A filter conforming to BS 1752 and having a pore size no greater than 100

31、 m shall be provided upstream of the pressure regulator. 8.1.3 Cylinder contents gauge 8.1.3.1 Analgesic machines shall be provided with a cylinder contents gauge. The scale of the gauge shall be marked “0, 1/4, 1/2, 3/4, FULL” and/or the equivalent in units of pressure. The lowest quartile of the g

32、auge shall be coloured red. 8.1.3.2 The cylinder contents gauge shall be accurate to (4 % of full scale reading 8 % of actual reading). The scale shall extend to at least 33 % above the nominal maximum filling pressure of the cylinder at a temperature of (20 3 C. 8.1.3.3 All components of the gauge

33、shall be thoroughly cleaned and degreased before assembly. 8.1.3.4 The gauge shall be supplied free from oil. NOTE The gauge should be kept free from oil during factory processes and tests. 8.1.3.5 The gauge shall be marked with the words “USE NO OIL”, or with the symbol shown in Figure 1. Figure 1

34、Symbol for “use no oil”BS 4272-2:1996 BSI 14 January 2003 3 8.1.3.6 The gauge shall have a restriction in the shank and a blow-out device in the back of the case. When tested as described in A.3, no parts of the gauge shall be expelled. 8.1.3.7 The windows of the gauge shall be made of non-splinteri

35、ng glass or plastics material. 8.1.3.8 The indicating end (centre to tip) of any pointer on the gauge shall contrast with the background and be clearly distinguishable from the remainder of the pointer. The pointer shall overlap but not obscure the scale marking. 8.1.4 Captive valve key The valve ke

36、y provided for opening the cylinder shall be made captive by means of a retaining chain or similar attachment, which shall withstand a static load of not less than 200 N without breaking. 8.1.5 Outlet connector of pressure regulator If the demand valve is designed to be detachable by the operator fr

37、om the cylinder pressure regulator, the outlet connector of the regulator shall be a pipeline 50/50 N 2 O/O 2female fitting conforming to BS EN 737-1 . 8.2 Analgesic machine for connection to a medical gas pipeline 8.2.1 Pipeline inlet direct probe If a pipeline inlet direct probe is provided, it sh

38、all conform to 4.5 of BS 5682:1998 . 8.2.2 Gas supply hoses 8.2.2.1 Resistance to pulling Gas supply hoses with connections fitted shall conform to BS EN 739 . 8.2.2.2 Connection to medical gas pipeline If a gas supply hose is provided and is designed to be detachable by the operator from the pipeli

39、ne, the connector to the gas source shall be a remote probe conforming to BS 5682. 8.2.2.3 Connection to demand valve inlet If a gas supply hose is provided and is designed to be detachable by the operator from the demand valve, the connector at the demand valve shall be NIST 50/50 O 2 /N 2 O confor

40、ming to BS EN 739 . NOTE Connections which are not detachable by the operator, i.e. which require the use of tools to detach, may be of a device-specific pattern. 8.2.2.4 Colour-coding Gas supply hoses shall be colour-coded blue and white as specified in 18.2 of BS 5682. 8.2.3 Flexible tube between

41、demand valve and patient connection port If a flexible tube is used to conduct gas between the demand valve and the patient connection port, it shall conform to BS EN 12342 . 9 Patient connection port The patient connection port shall have a 22 mm male conical connector conforming to BS EN 1281-1 .

42、NOTE The patient connection port may also have a 15 mm coaxial female conical connector conforming to BS EN 1281-1 . 10 Exhaust port If the analgesic machine is intended to be connected to an anaesthetic gas scavenging system, the exhaust port for gases from the breathing system of the analgesic mac

43、hine shall be a 30 mm male conical connector conforming to BS EN 1281-1 .BS 4272-2:1996 4 BSI 14 January 2003 11 Resistance to environmental conditions 11.1 The performance of the analgesic machine, as specified in clause 12, and clause 13 if applicable, and tested by the methods described in A.2, A

44、.4, A.5 and A.6, shall be achieved at ambient temperatures of (5 3) C, (20 3) C and (40 3 C. 11.2 When detached from gas cylinders, the analgesic machine shall conform to the transport and storage requirements of Clause 10 of BS EN 60601-1:1990 . 12 Performance 12.1 General 12.1.1 Analgesic machines

45、 intended for connection to a gas cylinder (see 8.1) shall meet the requirements of 12.2, 12.3 and 12.5 at cylinder pressures from full cylinder pressure down to 1 000 kPa. 12.1.2 Analgesic machines intended for connection to either a hospital pipeline or to a pressure regulator (see 8.2) shall meet

46、 the requirements of 12.2, 12.3 and 12.5 at inlet pressures between 280 kPa and 600 kPa. 12.2 Inspiratory flow characteristics When tested as described in A.4.2.2, the inspiratory differential pressure below atmospheric shall not exceed 1.5 kPa at a flow of 200 l/min. This flow shall be attained wit

47、hin 250 ms. When tested as described in A.4.2.3, the inspiratory differential pressure below atmospheric shall not exceed 0.25 kPa at a flow of 10 l/min. 12.3 Flow termination characteristic When tested as described in A.4.2.4, demand flow shall terminate before the differential pressure with respec

48、t to atmospheric becomes zero. 12.4 Leakage from patient connection port When tested as described in A.4.2.5, flow from the patient connection port under zero pressure differential with respect to atmospheric (e.g. when disconnected) shall not exceed 5 ml/min. 12.5 Expiratory resistance When tested

49、as described in A.5, the resistance to expiration shall not exceed 0.6 kPa at a continuous flow of 120 l/min, or 0.1 kPa at a continuous flow of 12 l/min. 13 Additional requirements for portable analgesic machines 13.1 If the analgesic machine is supplied ready for use in a carrying case or frame, it shall meet the requirements of clause 12 when fitted with a full cylinder, after it has been dropped as described in A.2 in