EN ISO 80601-2-13-2012 en Medical electrical equipment - Part 2-13 Particular requirements for basic safety and essential performance of an anaesthetic workstation《医疗电气设备 2 - 13部分 .pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 80601-2-13:2012Medical electrical equipmentPart 2-13: Particular requirements for basic safety and essentialperformance of an anaesthetic workstationBS EN ISO 80601-2-1

2、3:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 80601-2-13:2012. It is identical to ISO 80601-2-13:2011. It supersedes BS EN 60601-2-13:2006, BS EN ISO 8835-2:2009, BS EN ISO 8835-3:2009+A1:2010, BS EN ISO 8835-4:2009, and BS EN ISO 8835-5:2009, which

3、 are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/1, Breathing attachments and anaesthetic machines.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the

4、necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013.ISBN 978 0 580 77702 8 ICS 11.040.10 Compliance with a British Standard cannot confer immunityfrom legal obligations.This British Sta

5、ndard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80601-2-13 December 2012 ICS 11.040.10 Supersedes EN ISO 8835-2:2009, EN ISO 8835-3

6、:2009, EN ISO 8835-4:2009, EN ISO 8835-5:2009, EN 60601-2-13:2006 English Version Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) Appareils lectromdicaux - Partie 2-13: Exigences particul

7、ires de scurit de base et de performance essentielle pour les systmes danesthsie (ISO 80601-2-13:2011) Medizinische elektrische Gerte - Teil 2-13: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Ansthesie-Arbeitspltzen (ISO 80601-2-13:2011) This European

8、 Standard was approved by CEN on 18 November 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references conc

9、erning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member in

10、to its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,

11、Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITE

12、E FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 80601-2-13:2012: E BS EN ISO 80601-2-13:2012 EN ISO 80601-2-13:2012 (E) 3 Foreword The text of ISO 80601-2-1

13、3:2011 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic andrespiratory equipment” of the International Organization for Standardization (ISO) and has been taken over asEN ISO 80601-2-13:2012 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” thesecretariat of w

14、hich is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn atthe latest by December 2015. Attention is drawn to the possib

15、ility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8835-2:2009, EN ISO 8835-3:2009, EN ISO 8835-4:2009,EN ISO 8835-5:2009, EN 60601-2-13:2

16、006. This document has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Accordin

17、g to the CEN/CENELEC Internal Regulations, the national standards organisations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Gree

18、ce,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 80601-2-13:2011 has been approved by CEN as a EN ISO 80601-2-13:

19、2012 without anymodification. BS EN ISO 80601-2-13:2012EN ISO 80601-2-13:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirementsof EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commiss

20、ion and theEuropean Free Trade Association to provide a means to conforming to Essential Requirements of the NewApproach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the MemberStates concerning medical devices” (Medical Device Directive). Once this stand

21、ard is cited in the Official Journal of the European Union under that Directive and has beenimplemented as a national standard in at least one Member State, compliance with the clauses of this standardgiven in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conf

22、ormity with thecorresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/subclause(s) of this EN Corresponding essential requirements of Directive93/42/EEC Qualifying remarks/ynot

23、es 201.11.6.8; 201.102.3; 201.104.7 7.2 only the risks to patients during NORMAL USE are addressed 201.11.6.3; 201.11.6.8 7.3 201.7.2.105, 201.7.9.2.14 7.5, 2nd and 3rdparagraph 201.101.4.1.2; 201.11.6.3 7.6 IP classification according IEC 60529 is governed by EN 60601-1:2006 201.11.101; 201.104.7 8

24、.1 Easy handling and contamination by the patients are not addressed. 201.11.101 8.6 201.16.9.2.1; 201.16.101;201.101.3; 201.101.4.1201.101.4.2; 201.101.9; 201.102.5; 201.102.9; 201.103.4 to 201.103.7;201.104.4; 201.104.5, 201.104.6; 201.105.4; 201.105.6 9.1 201.9.4; 201.9.4.2.4.3; 201.105.7, 202; 2

25、09 9.2 (First and second indents) Clause 202 refers to EN 60601-1-2:2007, Clause 209 refers to EN 60601-1-9:2008 201.11; 201.102.4 9.3 201.12.4.104.1; 201.101.6.1; 201.104.2.2 10.1 BS EN ISO 80601-2-13:2012 EN ISO 80601-2-13:2012 (E) 5 Clause(s)/subclause(s) of this EN Corresponding essential requir

26、ements of Directive93/42/EEC Qualifying remarks/ynotes 201.7.4.2; 10.2 201.7.4.3 10.3 201.14 12.1 EN 62304:2006, 1.4 201.14, 201.14.101 12.1 a) EN 62304:2006, 1.4 201.11.8.102; 201.11.8.103 12.2 201.11.8.102 12.3 201.12.4.104.2; 201.12.4.105; 201.12.4.106; 208 12.4 Clause 208 refers to EN 60601-1-8:

27、2006 202 12.5 Clause 202 refers to EN 60601-1-2:2007 201.9 12.7.1 201.9, 201.9.2.103 12.7.2 201.9, 201.11.8.102 12.7.3 201.15, 201.16, 201.101.4.2.1 12.7.4 Covered by compliance with EN 60601-1:2006, 15.4.1 and 16.9 201.11 12.7.5 EN 60601-1:2006, Clause 11 201.101.4.1.3; 201.101.6.2;201.101.6.3; 201

28、.102.2.1;201.102.2.2; 201.102.10.4;201.104.2.1; 201.104.5; 201.105.2.1; 201.105.2.2; 12.8.1 201.12.4.104.2; 201.12.4.106;201.12.4.107.1; 201.12.4.107.2;201.12.4.107.3; 201.12.4.109; 201.101.2; 201.101.4.3; 201.102.10: 201.102.10.4;201.104.5; 201.105.5; 201.105.8; 208 12.8.2 201.101.6.1; 201.104.2.1;

29、 12.9 201.7, 201.7.2.104; 201.7.9.1; 201.102.1.1.1 13.1 201.7, 201.7.2.3; 201.7.2.101;201.7.2.103; 201.7.2.107; 201.7.4.2 13.2 201.7.9.1 13.3 a) 201.7.2.101 13.3 e) BS EN ISO 80601-2-13:2012EN ISO 80601-2-13:2012 (E) 6 Clause(s)/subclause(s) of this EN Corresponding essential requirements of Directi

30、ve93/42/EEC Qualifying remarks/ynotes 201.7, 201.7.2.101 13.3 f) The indication that the device is forsingle use must be consistentacross the Community is not addressed in a requirement. 201.7, 201.7.9.3.102 13.3 i) 201.7, 201.7.2 201.7.2.102, 201.7.2.103, 201.7.2.104201.7.2.107201.7.4.2 201.101.6.1

31、201.102.1.1.2201.102.1.1.3201.102.1.1.4201.102.5.2201.102.5.3201.102.5.4201.102.5.7201.103.1.1201.104.1.1201.104.2.1201.104.6201.105.6 13.3 j) 201.7, 201.7.2.3201.104.1.1 13.3 k) 201.7.2.101 13.3.l) 201.7.2.102; 201.102.5.2;201.102.5.4; 201.102.5.5;201.102.5.6; 201.103.5; 201.103.6; 201.104.4 13.5 2

32、01.7 13.6 a) Covered by compliance with EN 60601-1:2006, 7.9.2 201.7 13.6 b) Covered by compliance with EN 60601-1:2006, 7.9.2 201.7.9.2.1 201.7.9.2.14201.11.8201.11.8.101201.11.8.103201.12.4.102201.12.4.103.3201.12.4.106201.12.4.107.2201.12.4.108201.101.1.1201.101.1.2 201.102.1.2 13.6 c) BS EN ISO

33、80601-2-13:2012 EN ISO 80601-2-13:2012 (E) 7 Clause(s)/subclause(s) of this EN Corresponding essential requirements of Directive93/42/EEC Qualifying remarks/ynotes 201.102.7 201.102.8.2201.102.9.2201.102.9.3201.102.10.3201.103.1.2201.104.1.2201.104.2.1201.104.6201.105.1 201.105.2.2201.105.5 201.7, 2

34、01.102.10.1 201.103.3.1.5208.5.2.2 13.6 d) maintenance and frequencycovered by compliance with EN 60601-1:2006, 7.9.2.13 201.7.9.2.14 13.6 f) 201.7 201.7.9.2.14 13.6 h), first paragraph only Covered by compliance with EN 60601-1:2006, 7.9.2 201.7 201.7.9.2.1201.7.9.2.8 13.6 i) Covered by compliance

35、with EN 60601-1:2006, 7.9 201.7.9.2.2 201.7.9.2.14 13.6 k) 201.12.4.103 ; 201.12.4.104.1, 201.12.4.109; 201.101.6.1; 201.104.2.2; 13.6 p) 201.7.9.2.1 13.6 q) BS EN ISO 80601-2-13:2012EN ISO 80601-2-13:2012 (E) 8 For devices which are also machinery within the meaning of Article 2(a) of Directive 200

36、6/42/EC onMachinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.102 details the relevantessential health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they aremore specific than essential requirements of Directive 93/42/EEC along

37、with the corresponding clauses of thisEuropean Standard. Table ZA.102, however, does not imply any citation in the OJEU under the machinerydirective and thus does not provide presumption of conformity for the machinery directive. Table ZA.102 Relevant Essential Requirements from Directive 2006/42/EC

38、 on machinery thatare addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s)/subclause(s) of this EN EHSR of Directive 2006/42/EC Qualifying remarks/notes 201.9.2.102 1.1.4 201.9.2.103 1.1.8 201.7.4.2 201.9.2201.9.2.104201.101.6.1 201.102.1.1.2201.102.1

39、.1.3201.102.9.2 201.104.1.1201.104.2.1206 208 1.2.2 201.101.3201.101.4.1.1201.101.4.1.2201.101.9201.102.5201.102.8.1201.102.9.1 201.103.4, 201.103.5; 201.103.6201.103.7201.104.4 201.105.4201.105.6 1.5.4 201.9.2.101 1.6.2 201.8 1.6.3 201.7 201.7.2.106 3.6.2 Covered by compliance with EN 60601-1:2006,

40、 7.2 WARNING: Other requirements and other EU Directives may be applicable to the products falling within thescope of this European Standard. BS EN ISO 80601-2-13:2012ISO 80601-2-13:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword .v Introductionvi 201.1 Scope, object and related stand

41、ards.1 201.2 Normative references3 201.3 Terms and definitions .5 201.4 General requirements .9 201.5 General requirements for testing ME EQUIPMENT .11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents .11 201.8 Protection against electri

42、cal HAZARDS from ME EQUIPMENT.15 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS16 201.10 Protection against unwanted and excessive radiation HAZARDS 17 201.11 Protection against excessive temperatures and other HAZARDS 17 201.12 Accuracy of controls and instruments and pr

43、otection against hazardous outputs 19 201.13 HAZARDOUS SITUATIONS and fault conditions24 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .24 201.15 Construction of ME EQUIPMENT.25 201.16 ME SYSTEMS .25 201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS.26 201.101 Additional re

44、quirements for ANAESTHETIC GAS DELIVERY SYSTEMS .26 201.102 Additional requirements for an ANAESTHETIC BREATHING SYSTEM 32 201.103 Additional requirements for an ANAESTHETIC GAS SCAVENGING SYSTEM.39 201.104 Additional requirements for an ANAESTHETIC VAPOUR DELIVERY SYSTEM43 201.105 Additional requir

45、ements for an ANAESTHETIC VENTILATOR47 201.105.7 * Timed ventilatory pause .50 201.105.7.1 Expiratory pause 50 201.105.7.2 Inspiratory pause50 201.106 Display loops53 201.107 Clinical evaluation .53 202 Electromagnetic compatibility Requirements and tests.54 203 General requirements for radiation pr

46、otection in diagnostic X-ray equipment54 206 Usability54 208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS 55 209 Requirements for environmentally conscious design 55 BS EN ISO 80601-2-13:2012ISO 80601-2-13:2011(E) iv ISO 20

47、11 All rights reserved210 PROCESS requirements for the development of physiologic closed-loop controllers .56 211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in the home healthcare56 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPM

48、ENT and ME SYSTEMS or their parts 57 Annex D (informative) Symbols on marking.67 Annex AA (informative) Particular guidance and rationale.69 Annex BB (normative) Test for flammability of anaesthetic agent 84 Annex CC (informative) Environmental aspects 85 Annex DD (informative) Reference to the esse

49、ntial principles.87 Bibliography 94 Alphabetized index of defined terms used in this particular standard .96 BS EN ISO 80601-2-13:2012ISO 80601-2-13:2011(E) ISO 2011 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to b