CSA Z168 3-1997 Anaesthetic machines for medical use (Fourth Edition General Instruction No 1 March 1997).pdf

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1、Z168.3-97(reaffirmed 2011)Anaesthetic machines for medical useBlank pageGeneral Instruction No. 1Z168.3-97March 1997Title: Anaesthetic machines for medical usePagination: 45 pages, each dated March 1997To register for e-mail notification about any updates to this publication go on-line to shop.csa.c

2、aclick on E-mail Services under MY ACCOUNTclick on CSA Standards Update ServiceThe List ID that you will need to register for updates to this publication is 2006081.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs policy on privacy at csagroup.org/legal to f

3、ind out how we protect your personal information.Blank pageAnaesthetic Machines for Medical Use ISSN 03 17-5669 Published in March 7 997 bY Canadian Standards Association 7 78 Rexdale Boulevard, Etobicoke, Ontario, Canada MPW lR3 Technical Editor: Larry Futers Manuging Editor: Gary Burford Senior Pr

4、oject Editor: Ann Martin ditor: Maria Adrugna 0 Cancldiun Standards Association - 7 997 - Publishing System Coordinators: Ursula Das/Crace Do Silva All rights reserved. No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior permis

5、sion of the publisher. Anaesthetic Machines for Medical Use Contents Technical Committee on Anaesthetic Equipment and Respiratory Technology vi Preface vi Foreword ix 1. Scope 1 2. Definitions and Reference Publications 2.1 Definitions I 2.2 Reference Publications 2 7 3. General Requirements 3 3.1 R

6、elevant Standards 3 3.2 General Design Requirements 3 3.3 Hypoxic Mixture Protection and Oxygen Analyser 4 4. Pipeline Inlet and Power Outlet Connections 4 4.1 General 4 4.2 Fittings 4 4.3 Filters 5 4.4 Checkvalves 5 4.5 Outlet Connections 5 5. Medical Cas Cylinder Inlet Connections 5.1 General 5 5.

7、2 Connection 5 5.3 Marking 6 5.4 Two or More Connections 6 6. Pressure-lndtcating Devices 6.1 General 6 6.2 Cylinder Pressure Gauges 6.3 Pipeline Pressure Gauges 6.4 Pressure Units 7 6 7 7 6 5 7. Flow Control System 7.1 General 7 7.2 Detailed Requirements for Flowmeters 7 7.3 Detailed Requirements f

8、or Flow Control Systems 8. Pressure Regulators 8 8.1 General 8 8.2 Detailed Requirements 8 8 9. Piping System (Anaesthetic Machine) 9 9.1 Pressure 9 9.2 Leakage Between Inlets and Flow Control Valves 9 9.3 Leakage Between Flow Control Valves and Outlets 9 9.4 Labelling of Pipework 9 9.5 Assembly and

9、 Connection 9 March 7 997 iii Z7 68.3-97 9.6 10. 10.1 10.2 11. 17.1 11.2 12. 12.1 12.2 12.3 13. 13.1 13.2 13.3 14. 14.1 14.2 14.3 14.4 14.5 15. 15.1 Compatibility 9 Flow Control Valves 70 General 70 Detailed Requirements 7 0 Oxygen Flush Valves 72 General 72 Detailed Requirements 72 Vaporizer System

10、s 7 2 Fitting of Vaporizers 72 General Requirements - Filling Mechanism and Overfill Protection Concentration-Cali brated Vaporizer Systems 74 Common Cas Outlet of the Machine General 75 Supporting Structure 75 Standard Load-Bearing Connectors 7 5 General 75 Alarm Requirements 75 Protection Device 7

11、 6 Pneumatically Powered Alarms 76 Equipment and Supplies 76 73 75 Oxygen Supply Failure Precautions 74 Shut-Off 76 Test Methods 76 15.1.1 Test Gases 76 15.1.2 Anaesthetic Agents 7 7 15.1.3 Test Instrumentation 77 15.2 Test Conditions 78 15.3 General Requirements 78 15.3.1 Visual Inspection 78 15.3.

12、2 Tp-Over I9 15.3.3 Legibility of Controls and Instruments 19 15.3.4 Hypoxic Mixture Alarm 79 15.4 Pipetine Inlet and Power Outlet Connections 20 75.4.1 Visual Inspection 20 15.4.2 Check Valves 20 15.4.3 Connector Specificity 20 15.5 Medical Gas Cylinder Inlet Connections 20 15.5.1 Visual Inspection

13、 20 15.5.2 Test for Connector Specificity 20 15.5.3 Cross-Flow Test 20 15.6 Pressure Gauges - Visual Inspection 27 15.7 Flowmeters - Visual Inspection 27 15.8 Pressure Regulators 27 15.8.1 Visual Inspection 27 15.8.2 Excess Pressure Tests 27 March 1997 Anaesthetic Machines for Medical Use 15.8.3 Sup

14、ply Switching 22 15.9 Piping System 22 15.9.1 Visual Inspection 22 15.9.2 Assembly 22 15.9.3 Pressure-Limiting and Rupture Tests 23 15.9.4 High-pressure Leak Test 23 15.9.5 Low-Pressure Leak Test 23 15.1 0 Flow Control Valves 23 15.1 0.1 Visual Inspection 23 15.1 0.2 Control Valve Operation 24 15.1

15、0.3 Durability 24 15.1 1 Oxygen Flush Valves 24 15.1 1.1 Visual Inspection 24 15.1 1.2 Flush Valve Operation 24 15.1 2 Vaporizer Systems 25 15.1 2.1 General Requirements 25 15.1 2.2 Concentration-Calibrated Vaporizers 26 15.1 3 Common Gas Outlet 27 15.1 3.1 Fitting Dimensions 27 15.1 3.2 Torque Appl

16、ication 27 15.1 4 Oxygen Supply Failure Precautions 27 Tables 27 Figures 28 Appendices A - Materials 33 B - Derivation of Formula for Supply-Switching Leakage Rate 34 March 7997 V 27 68.3-97 Technical Committee on Anaesthetic Equipment and Respiratory Techno logy LA. Sloan Hospital for Sick Children

17、, Toronto, Ontario Representing the Canadian Anaesthetists Society Chair D. Reimer Vice- Chair Health Sciences Centre, Winnipeg, Manitoba Representing the Canadian Anaesthetists Society Benson Medical Industries Ltd., Markham, Ontario R. Benson University of British Columbia, Vancouver, British Colu

18、mbia Associate D. Bevan L. Brautigam Nellcor Puritan Bennett Canada ktd., Pickering, Ontario D. Cashen Dartmouth, Nova Scotia Representing the Canadian Society for Respiratory Therapists 5. Dah London Health Sciences Centre, London, Ontario Representing the Canadian Anaesthetists Society J. Doyle Th

19、e Toronto Hospital, Toronto, Ontario Representing the Canadian Anaesthetists Society A. Finley I.W.K. Grace Health Centre, Halifax, Nova Scotia S.C. Chanthan Associate Standards Council of Canada, Ottawa, Ontario A. Green Associate Penlon Ltd., Abingd on, Oxf ordshi re, Eng la nd E.M. Koshowski 0 h

20、med a P ha rmaceu t ica I B rod ucts, Mississauga, Ontario Associate Vi March 1997 Anaesthetic Machines for Medical Use W. Lambert M. Livesque V Mankiewicz P.M. Marsden L. McDonald G. Mender A.S. Sinclair C.M. Smtth H. Thiemann C L. Welycz ko L. Futers Sudbury) Ontario Rep re sen ting the Canadian A

21、naes th etis fs Society Ma II i nckrodt Medical I nc., Pointe-Claire, Quebec 0 h m ed a B ha r maceu tica 1 Prod ucts, Mississauga, Ontario Health Industry Consultants, Etobicoke, Ontario Southmedic Inc., Barrie, Ontario Nellcor Puritan Bennett Canada Ltd., Pickering, Ontario Health Canada, Medical

22、Devices Bureau, Ottawa, Ontario Puritan Ben nett, Lenexa, Kansas, USA North American Drager NAD. Inc., Telford, Pennsylvania, USA Ohmeda, Madison, Wisconsin, USA Canadian Standards Passociati o n, Etobicoke, Ontario A sso ciu te Associate Associate Associate Administrator March 7997 vii 27 68.3- 97

23、Preface This is the fourth edition of CSA Standard Z168.3, Anaesthetic Machines for Medical Use. It supersedes the third edition, entitled Continuous-Flow Inhalation Anaesthetic Apparatus (Anaesthetic Machines) for Medical (b) provide an explanation of circumstances surrounding the actual field cond

24、ition; and (c) be phrased where possible to permit a specific “yes“ or “no“ answer. lnterpretations are published in CSAS periodical Info Update. for subscription details, write to CIA Sales Promotion, Info Update, at the address given above. viii March 1997 Anaesthetic MacRines for Medical Use Fove

25、word Canadian Standards Association provides certification services for manufacturers who, under license from CSA, wish to use the appropriate registered CSA Mark on certain products f their manufacture to indicate conformity with CSA Standards. CSA Certification for a number of products is provided

26、 in the interest of maintaining agreed-upon standards of quality, performance, interchangeability and/or safety, as appropriate. Where applicable, certification may form the basis for acceptance by inspection authorities responsible for enforcement of regulations. Where feasible, programs will be de

27、veloped for additional products for which certification is desired by producers, consumers or other interests. In performing its functions in accordance with its objectives, CSA does not assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and find

28、ings of the Association represent its professional judgement given with due consideration to the necessary limitations of practical operation and state of the art at the time the Standard is processed. Products in substantial accord with this Standard but which exhibit a minor difference or a new fe

29、ature may be deemed to meet the Standard providing the feature or difference is found acceptable utilizing appropriate CSA Certification Division Operating Procedures. Products which comply with this Standard shall not be certified if they are found to Rave additional features which are inconsistent

30、 with the intent of this Standard. Products shall not be certifiable if they are discovered to contravene applicable Federal laws or regulations. Testing techniques, test procedures and instrumentation frequently must be prescribed by the CSA Certification Division in addition to the technical requi

31、rements contained in Standards of CSA. In addition to markings specified in the Standard the CSA Certification and Testing Division may require special cautions, markings and instructions that are not specified by the Standard. Some tests required by CSA Standards may be inherently hazardous. The As

32、sociation neither assumes nor accepts any responsibility for any injury or damage that may occur during or as the result of tests, wherever performed, whether performed in whole or in part by the manufacturer or the Association, and whether or not any equipment, facility or personnel for or in conne

33、ction with the test is furnished by the manufacturer or the Association. Manufacturers should note that, in the event of the failure of the CSA Certification and Testing Division to resolve an issue arising from the interpretation of requirements, there is an appeal procedure: the complainant should

34、 submit the matter, in writing, to the Secretary of the Canadian Standards Association. If this Standard is to be used in obtaining CSA Certification please remember, when making application for certification, to request all current Amendments, Bulletins, Notices and Technical Information Letters th

35、at may be applicable and for which there may be a nominal charge. For such information or for further information concerning details about CSA Certification please address your inquiry to the Applications and Records Section, Canadian Standards Association, 1 78 Rexdale Boulevard, Etobicoke, Ontario

36、 M9W 1 R3. March 7997 Blank pageAnaesthetic Muchines for Medical Use 21 68.3-97 Anaesthetic Machines for Medical Use 1. Scope 1.1 This Standard outlines basic safety and performance requirements for anaesthetic machines and components thereof for use with humans. 1.2 The requirements of this Standar

37、d are intended to enhance patient safety. 1.3 This Standard excludes requirements for anaesthesia ventilators (see CSA Standard CAN/CSA-Z168.5.1. 1.4 This Standard excludes specific provisions for (a) anaesthetic machines equipped to deliver flammable anaesthetics agents; (b) draw-over vaporizers; (

38、c) dental nitrous oxideloxygen analgesia machines; (d) breathing circuits; and (e anaesthetic gas scavenging systems. 2. Definitions and Reference Publications 2.1 Definitions The following definitions apply in this Standard: Anaesthetic machine - equipment for dispensing and delivering medical and

39、anaesthetic gases and vapours into a breathing system. Anaesthetic vaporizer - a device designed to facilitate the change of an anaesthetic agent from a liquid to a vapour. Breathing system - those gas pathways continuously or intermittently in communication with a patients respiratory tract during

40、any form of ventilation. Check valve - an automatically actuated valve that prevents reverse flow of gas. Common gas outlet - the port through which the dispensed mixture from the anaesthetic machine is delivered to the breathing system. Flow control valve - a device that controls the flow of a gas

41、through its associated flowmeter by manual adjustment. March 7997 1 Z I 68.3-97 Flowmeter (fIow metering device) - any device that indicates the volume of a specific gas or gas mixture passing through it in a unit of time. Gas mixing device (gas mixer) - a device that receives separate supplies of o

42、xygen and other medical gas(es), and deIivers the mixed gases in concentrations adjustable by the operator. Hypoxic mixture - a mixture of medical gases that contains less than 21% oxygen. Room temperature and pressure (RTP) - ambient conditions of 20C and 109.3 kPa (absolute). Note: Unless otherwis

43、e specified, pressure vahes are referred to in ambient atmospheric pressure. 2.2 Reference Publications This Standard refers to the following publications and where such reference is made it shall be to the edition listed below. Where reference is made to other publications, such reference shall be

44、considered to refer to the latest edition and all amendments published to that edition up to the time when this Standard was approved. CSA Standards c22.1-94, Canadian Electrical Code, Part l; C22.2 NO. 125-M1984 (R1992), Electro m edical Equipment; CAN/CSA-C22.2 NO. 601.1 -M90, Medical Electrical E

45、quipment Part 7 : General Requirements for Safety; Anaesthesia Ventilators; CAN/CSA-Z168.5.1-97, CAN/CSA-Z305.1-92, Nonflammuble Medical Gas Piping Systems; CAN/CSA-Z305.2-M88, bow- Pressure Connecting Assemblies for Medical Gas Systems; Pressure Regulators, Gauges, and Flow-Metering Devices for Med

46、ical Gases; CAN/CSA-Z305.3-M87, CAN/CSA-Z5360-94, Anaesthetic Vaporizers - Agent-Specific Filling Systems. ANSI* Standard Specification for Sound Level Meters. S1.4-1983, CCAf Standards v-1 -1 994, Standard for Compressed Cas Cylindersl Valve, Outlet and Inlet Connections (replaces CSA B96- 7 977);

47、V-5-1989, Diameter lndex Safety System. 2 March 7997 Anaesthetic Machines for Medical Use CCSBl Standard, identification of Medical Cas Containers, Pipehes, and Valves. CAN/CGSB-24.2-M86, IS05 Standards 3746: 1979, Acoustics - Determination of Sound Power ievels of Noise Sources - Survey Method; 535

48、8: 1992, Anaesthetic Machines for Medical Use with Humans; 9703-1 : 1992 (under preparation as CAN/CSA-IS0 9703.1 -97), Anaesthesia and respiratory care alarm signals - Part I: Visual ajarm signals; 9703-2: 1994 (under preparation as CAN/CSA-IS0 9703.2-97), Anaesthesia and respiratory care alarm sig

49、nals - Part 2: Auditory alarm signals. Medical Devices Regulations Schedule Xi!, /? C. 7 992-2058, September 9 7, 7 992, Medical Devices Regulations, Chapter 87 7, Consolidated Regulations of Canada, 7 978. *American National Standards Institute. +Compressed Gas Association. $.Canadian General Standards Board. International Organization for Standardization. 3. General Requirements 3.1 Relevant Standards Anaesthetic machines, including alarms and electrically heated vaporizers, shall comply with the applicable requirements in the Canadian Electrical Code, Part I and CSA Standard