IEC 60601-2-13-2003 Medical electrical equipment - Part 2-13 Particular requirements for the safety and essential performance of anaesthetic systems《医用电气设备.第2-13部分 麻醉系统安全和基本性能的特殊要求》.pdf

1、INTERNATIONALSTANDARDIEC60601-2-13Third edition2003-05Medical electrical equipment Part 2-13:Particular requirements for the safety andessential performance of anaesthetic systemsAppareils lectromdicaux Partie 2-13:Rgles particulires de scurit etperformance essentielle pour les systmes danesthsieRef

2、erence numberIEC 60601-2-13:2003(E)Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Publication numberingAs from 1 January 1997 all IEC publications are issued with a designati

3、on in the60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.Consolidated editionsThe IEC is now publishing consolidated versions of its publications. For example,edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, thebase publication incorporating amendm

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8、omerService Centre (see below) for further information. Customer Service CentreIf you have any questions regarding this publication or need further assistance,please contact the Customer Service Centre:Email: custserviec.chTel: +41 22 919 02 11Fax: +41 22 919 03 00Copyright International Electrotech

9、nical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-INTERNATIONALSTANDARDIEC60601-2-13Third edition2003-05Medical electrical equipment Part 2-13:Particular requirements for the safety andessential performance of an

10、aesthetic systemsAppareils lectromdicaux Partie 2-13:Rgles particulires de scurit etperformance essentielle pour les systmes danesthsiePRICE CODE IEC 2003All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by anymeans, electronic

11、or mechanical, including photocopying and microfilm, without permission in writing from the publisher.IEC Copyright Office Case postale 56 CH-1211 Genve 20 SwitzerlandXFor price, see current catalogueCopyright International Electrotechnical Commission Provided by IHS under license with IECNot for Re

12、saleNo reproduction or networking permitted without license from IHS-,-,- 2 60601-2-13 IEC:2003(E)CONTENTSFOREWORD . 4INTRODUCTION . 6SECTION ONE GENERAL1 Scope and object 72 Terminology and definitions 103 General requirements 124 General requirements for tests126 Identification, marking and docume

13、nts 12SECTION TWO ENVIRONMENTAL CONDITIONS10 Environmental conditions .16SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDSSECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDSSECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OREXCESSIVE RADIATIONSECTION SIX PROTECTION AGAINST HAZARDS OF IGNIT

14、ION OF FLAMMABLEANAESTHETIC MIXTURESSECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES ANDOTHER SAFETY HAZARDS*43 Fire prevention .1844 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilizationand disinfection 1849 Interruption of the POWER SUPPLY 19SECTION EIGHT ACCURA

15、CY OF OPERATING DATA AND PROTECTIONAGAINST HAZARDOUS OUTPUT51 Protection against hazardous output .19SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONSENVIRONMENTAL TESTS52 Abnormal opertion and fault conditions .23SECTION TEN CONSTRUCTIONAL REQUIREMENTS54 General 2456 Components and general assem

16、bly 2457 MAINS PARTS, components and layout24Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-60601-2-13 IEC:2003(E) 3 SECTION 101 ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GA

17、SDELIVERY SYSTEMS101 Medical gas supply.25102 Medical gas pipeline inlet connections .25103 Medical gas supply pressure monitoring.26104 Medical gas supply PRESSURE REGULATORs.26105 Anaesthetic gas delivery system piping .26106 Gas flow metering .27107 Gas mixer 28108 Oxygen flush29109 Fresh gas out

18、let .29110 Checklist29Annex AA (informative) Guidance and rationale for particular clauses and subclausesin this particular standard .30Annex BB (informative) MONITORING DEVICES, ALARM SYSTEM(S) and PROTECTION DEVICES34Annex CC (informative) Separate devices of an ANAESTHETIC SYSTEM 35Annex DD (norm

19、ative) Test for flammability of anaesthetic agent .37Annex EE (informative) Clauses of this International Standard addressingthe essential requirements or other provisions of EU directives 38Bibliography .43Index of defined terms 44Figure 101 Profile of oxygen flow control knob for applications othe

20、r than anaestheticvapour delivery device flow control (See 106.3) .28Table 101 Test conditions for expiratory volume tests 21Table 102 Force of axial pulls 25Table BB.1 Summary of the relationship of MONITORING DEVICES, ALARM SYSTEM(S)and PROTECTION DEVICES with regard to delivery devices34Table CC.

21、1 Applicable requirement clauses for separate devices ofan ANAESTHETIC SYSTEM 35Table EE.1 Correspondence between this International Standard and EEC Directive93/42/EEC 38Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networ

22、king permitted without license from IHS-,-,- 4 60601-2-13 IEC:2003(E)INTERNATIONAL ELECTROTECHNICAL COMMISSION_MEDICAL ELECTRICAL EQUIPMENT Part 2-13: Particular requirements for the safetyand essential performance of anaesthetic systemsFOREWORD1) The IEC (International Electrotechnical Commission)

23、is a worldwide organization for standardization comprisingall national electrotechnical committees (IEC National Committees). The object of the IEC is to promoteinternational co-operation on all questions concerning standardization in the electrical and electronic fields. Tothis end and in addition

24、to other activities, the IEC publishes International Standards. Their preparation isentrusted to technical committees; any IEC National Committee interested in the subject dealt with mayparticipate in this preparatory work. International, governmental and non-governmental organizations liaisingwith

25、the IEC also participate in this preparation. The IEC collaborates closely with the InternationalOrganization for Standardization (ISO) in accordance with conditions determined by agreement between thetwo organizations.2) The formal decisions or agreements of the IEC on technical matters express, as

26、 nearly as possible, aninternational consensus of opinion on the relevant subjects since each technical committee has representationfrom all interested National Committees.3) The documents produced have the form of recommendations for international use and are published in the formof standards, tech

27、nical specifications, technical reports or guides and they are accepted by the NationalCommittees in that sense.4) In order to promote international unification, IEC National Committees undertake to apply IEC InternationalStandards transparently to the maximum extent possible in their national and r

28、egional standards. Anydivergence between the IEC Standard and the corresponding national or regional standard shall be clearlyindicated in the latter.5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for anyequipment declared to be in conformity wit

29、h one of its standards.6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subjectof patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.International Standard IEC 60601-2-13 has been developed by

30、 a Joint Working Groupconsisting of IEC/SC 62D, Electromedical equipment, of IEC technical committee 62:Electrical equipment in medical practice, and ISO TC 121/SC 1, Breathing attachments andanaesthetic machines.It is published as double logo standard.This third edition cancels and replaces the sec

31、ond edition published in 1998. This editionconstitutes a technical revision.The text of this Particular Standard is based on the following documents:FDIS Report on voting62D/475/FDIS 62D/476/RVDFull information on the voting for the approval of this Particular Standard can be found in thereport on v

32、oting indicated in the above table. In ISO, the standard has been approved by 13P-members out of 13 having cast a vote.This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.In this Particular Standard, the following print types are used: requirements, compliance with wh

33、ich can be tested and definitions: roman type; explanations, advice, notes, general statements, exceptions and references: smaller type;Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from

34、 IHS-,-,-60601-2-13 IEC:2003(E) 5 test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS PARTICULAR STANDARD:SMALL CAPITALS.The committee has decided that the contents of this publication will remain unchanged until2007. At this date, the publication will be r

35、econfirmed; withdrawn; replaced by a revised edition, or amended.Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- 6 60601-2-13 IEC:2003(E)INTRODUCTIONIn response to requests f

36、or harmonization between the current European and Internationalstandards for anaesthetic workstations this standard has been developed by theIEC/ISO Joint Working Group to specify requirements for ANAESTHETIC SYSTEMS suppliedcomplete, as well as requirements for individual devices which are intended

37、 to be part of anANAESTHETIC SYSTEM. It applies in conjunction with IEC 60601-1:1988 (Including allamendments) hereafter referred to as the General Standard. As stated in 1.3 ofIEC 60601-1-1988, the requirements in this standard take priority over those of the GeneralStandard.This standard has been

38、structured to allow USERS to configure an ANAESTHETIC SYSTEM inconformance with professional guidelines and to meet the needs of their clinical practice.In order to achieve this aim, the standard identifies particular requirements pertinent tospecific devices, and to their associated MONITORING DEVI

39、CE(S), ALARM SYSTEM(s) andPROTECTION DEVICE(S), and defines the interfaces. This standard also specifies requirementsfor optional devices, together with their respective MONITORING DEVICE(S), ALARM SYSTEM(S)and PROTECTION DEVICE(S).The indicated requirements are followed by specifications for the re

40、levant tests. An asterisk(*) denotes clauses for which there is a rationale comment in Annex AA. It is considered thatknowledge of the reasons for these requirements will facilitate the proper application of thestandard and be of use in any revision that may be necessitated by changes in clinicalpra

41、ctice or as a result of developments in technology.NOTE The decimal separator for all numeric values is “,“ (comma).The following graphic representation of the structure of this standard is being provided forinformational purposes only.General requirementsANAESTHETIC gasdelivery deviceMonitoring, al

42、armand protectiondevices *)ANAESTHETICbreathing systemAGSSAnaesthetic vapourdelivery deviceAnaestheticventilatorOther devices(s)Monitoring, alarmand protectiondevices *)Monitoring, alarmand protectiondevices *)Monitoring, alarmand protectiondevices *)Monitoring, alarmand protectiondevices *)IEC 6060

43、1-2-13ISO 8835-2ISO/DIS 8835-3ISO/DIS 8835-4ISO/DIS 8835-5ISO/DIS 8835-XMandatoryOptionaldevicesAnaestheticsystemCopyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-60601-2-13 IEC

44、2003(E) 7 MEDICAL ELECTRICAL EQUIPMENTPart 2-13: Particular requirements for the safetyand essential performance of anaesthetic systemsSECTION ONE GENERALThe clauses and subclauses of this section of the General Standard apply except as follows:1 Scope and objectThis clause of the General Standard

45、applies except as follows:1.1 ScopeAdditionThis Particular Standard specifies safety and essential performance requirements for anANAESTHETIC SYSTEM (as defined in 2.101.7) as well as individual devices designed for use inan ANAESTHETIC SYSTEM.This Particular Standard does not apply to: ANAESTHETIC

46、SYSTEM(S) intended for use with flammable anaesthetic agents, asdetermined by Annex DD, portable ANAESTHETIC SYSTEM(S) for use in remote sites, open fields for rescue operationsor in disaster areas, dental analgesia apparatus.1.2 ObjectReplacement:The object of this Particular Standard is to specify

47、 particular safety and essential performancerequirements for individual devices designed for use in an ANAESTHETIC SYSTEM as well asspecific requirements for the ANAESTHETIC GAS DELIVERY SYSTEM. This standard specifiesrequirements and defines interfaces for: individual devices designed for use in an

48、 ANAESTHETIC SYSTEM(S), and integrated ANAESTHETIC SYSTEMS.1.3 Particular StandardsThis Particular Standard amends and supplements a set of IEC publications consisting ofIEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety,its amendment 1 (1991) and amendment 2 (1995), hereinafter referred to as the “GeneralStandard”.The General Standard takes into account IEC 60601-1-1:2000, Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements formedical e