IEC 60601-2-13 Edition 3.1-2009 Medical electrical equipment - Part 2-13 Particular requirements for the safety of anaesthetic systems《医疗电气设备.第2-13部分 麻醉系统安全性的详细要求》.pdf

1、 IEC 60601-2-13Edition 3.1 2009-08INTERNATIONAL STANDARD Medical electrical equipment Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems IEC60601-2-13:2003+A1:2006(E)THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All ri

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9、ATIONAL STANDARD Medical electrical equipment Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems INTERNATIONAL ELECTROTECHNICAL COMMISSION CJICS 11.040.10 PRICE CODEISBN 2-8318-1058-8 Registered trademark of the International Electrotechnical Commissio

10、n 2 60601-2-13 IEC:2003+A1:2006(E) CONTENTS FOREWORD 4 INTRODUCTION 6 SECTION ONE GENERAL 1 Scope and object .7 2 Terminology and definitions10 3 General requirements 12 4 General requirements for tests .12 6 Identification, marking and documents12 SECTION TWO ENVIRONMENTAL CONDITIONS 10 Environment

11、al conditions .17 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN

12、 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS *43 Fire prevention .18 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 19 49 Interruption of the POWER SUPPLY19 SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST

13、HAZARDOUS OUTPUT 51 Protection against hazardous output.20 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions .24 SECTION TEN CONSTRUCTIONAL REQUIREMENTS 54 General 24 56 Components and general assembly 24 57 MAINS PARTS, components an

14、d layout .25 60601-2-13 IEC:2003+A1:2006(E) 3 SECTION 101 ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GAS DELIVERY SYSTEMS 101 Medical gas supply 26 102 Medical gas pipeline inlet connections .26 103 Medical gas supply pressure monitoring 26 104 Medical gas supply PRESSURE REGULATORs 27 105 Anaesthet

15、ic gas delivery system piping .27 106 Gas flow metering .27 107 Gas mixer 29 108 Oxygen flush .29 109 Fresh gas outlet.30 110 Checklist30 Annex AA (informative) Guidance and rationale for particular clauses and subclauses in this particular standard .31 Annex BB (informative) MONITORING DEVICES, ALA

16、RM SYSTEM(S) and PROTECTION DEVICES .35 Annex CC (informative) Separate devices of an ANAESTHETIC SYSTEM .36 Annex DD (normative) Test for flammability of anaesthetic agent.38 Annex EE (informative) Clauses of this International Standard addressing the essential requirements or other provisions of E

17、U directives 39 Bibliography .44 Index of defined terms .45 Figure 101 Profile of oxygen flow control knob for applications other than anaesthetic vapour delivery device flow control (See 106.3) .29 Table 101 Test conditions for expiratory volume tests21 Table 102 Force of axial pulls 25 Table BB.1

18、Summary of the relationship of MONITORING DEVICES, ALARM SYSTEM(S) and PROTECTION DEVICES with regard to delivery devices .35 Table CC.1 Applicable requirement clauses for separate devices of an ANAESTHETIC SYSTEM .36 Table EE.1 Correspondence between this International Standard and EEC Directive 93

19、/42/EEC.39 4 60601-2-13 IEC:2003+A1:2006(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organ

20、ization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities,

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29、ons is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standar

30、d IEC 60601-2-13 has been developed by a Joint Working Group consisting of IEC/SC 62D, Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice, and ISO TC 121/SC 1, Breathing attachments and anaesthetic machines. It is published as double logo standard. This

31、 consolidated version of IEC 60601-2-13 consists of the third edition (2003) documents 62D/475/FDIS and 62D/476/RVD and its amendment 1 (2006) documents 62D/516/CDV and 62D/537A/RVC. The technical content is therefore identical to the base edition and its amendment and has been prepared for user con

32、venience. It bears the edition number 3.1. 60601-2-13 IEC:2003+A1:2006(E) 5 A vertical line in the margin shows where the base publication has been modified by amendment 1. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this Particular Standard, the following

33、 print types are used: requirements, compliance with which can be tested and definitions: roman type; explanations, advice, notes, general statements, exceptions and references: smaller type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS PARTICULAR ST

34、ANDARD: SMALL CAPITALS. The committee has decided that the contents of the base publication and its amendments will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the public

35、ation will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 6 60601-2-13 IEC:2003+A1:2006(E) INTRODUCTION In response to requests for harmonization between the current European and International standards for anaesthetic workstations this standard has been developed by the IEC/I

36、SO Joint Working Group to specify requirements for ANAESTHETIC SYSTEMS supplied complete, as well as requirements for individual devices which are intended to be part of an ANAESTHETIC SYSTEM. It applies in conjunction with IEC 60601-1:1988 (Including all amendments) hereafter referred to as the Gen

37、eral Standard. As stated in 1.3 of IEC 60601-1-1988, the requirements in this standard take priority over those of the General Standard. This standard has been structured to allow USERS to configure an ANAESTHETIC SYSTEM in conformance with professional guidelines and to meet the needs of their clin

38、ical practice. In order to achieve this aim, the standard identifies particular requirements pertinent to specific devices, and to their associated MONITORING DEVICE(S), ALARM SYSTEM(s) and PROTECTION DEVICE(S), and defines the interfaces. This standard also specifies requirements for optional devic

39、es, together with their respective MONITORING DEVICE(S), ALARM SYSTEM(S) and PROTECTION DEVICE(S). The indicated requirements are followed by specifications for the relevant tests. An asterisk (*) denotes clauses for which there is a rationale comment in Annex AA. It is considered that knowledge of

40、the reasons for these requirements will facilitate the proper application of the standard and be of use in any revision that may be necessitated by changes in clinical practice or as a result of developments in technology. NOTE The decimal separator for all numeric values is “,“ (comma). The followi

41、ng graphic representation of the structure of this standard is being provided for informational purposes only. General requirementsANAESTHETIC gasdelivery deviceMonitoring, alarmand protectiondevices *)ANAESTHETICbreathing systemAGSSAnaesthetic vapourdelivery deviceAnaestheticventilatorOther devices

42、(s)Monitoring, alarmand protectiondevices *)Monitoring, alarmand protectiondevices *)Monitoring, alarmand protectiondevices *)Monitoring, alarmand protectiondevices *)IEC 60601-2-13ISO 8835-2ISO/DIS 8835-3ISO/DIS 8835-4ISO/DIS 8835-5ISO/DIS 8835-XMandatoryOptionaldevicesAnaestheticsystem60601-2-13 I

43、EC:2003+A1:2006(E) 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems SECTION ONE GENERAL The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object This clause of the G

44、eneral Standard applies except as follows: 1.1 Scope Addition This Particular Standard specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM (as defined in 2.101.7) as well as individual devices designed for use in an ANAESTHETIC SYSTEM. This Particular Standard does not

45、apply to: ANAESTHETIC SYSTEM(S) intended for use with flammable anaesthetic agents, as determined by Annex DD, portable ANAESTHETIC SYSTEM(S) for use in remote sites, open fields for rescue operations or in disaster areas, dental analgesia apparatus. 1.2 Object Replacement: The object of this Partic

46、ular Standard is to specify particular safety and essential performance requirements for individual devices designed for use in an ANAESTHETIC SYSTEM as well as specific requirements for the ANAESTHETIC GAS DELIVERY SYSTEM. This standard specifies requirements and defines interfaces for: individual

47、devices designed for use in an ANAESTHETIC SYSTEM(S), and integrated ANAESTHETIC SYSTEMS. 1.3 Particular Standards This Particular Standard amends and supplements a set of IEC publications consisting of IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety, its amend

48、ment 1 (1991) and amendment 2 (1995), hereinafter referred to as the “General Standard”. 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 for medical electrical systems and IEC

49、60601-1-2 2001, Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests. 8 60601-2-13 IEC:2003+A1:2006(E) The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: “Replacement” means that