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
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