EN ISO 80601-2-55-2018 en Medical electrical equipment - Part 2-55 Particular requirements for the basic safety and essential performance of respiratory gas monitors.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Medical electrical equipmentPart 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitorsBS EN ISO 80601-2-55:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO

2、80601-2-55 February 2018 ICS 11.040.10 Supersedes EN ISO 80601-2-55:2011English Version Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018) Appareils lectromdicaux - Partie 2-55: Exigences

3、particulires relatives la scurit de base et aux performances essentielles des moniteurs de gaz respiratoires (ISO 80601-2-55:2018) Medizinische elektrische Gerte - Teil 2-55: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von berwachungsgerten fr Atemgase (

4、ISO 80601-2-55:2018) This European Standard was approved by CEN on 18 January 2018. 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 an

5、d bibliographical references concerning 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

6、responsibility of a CEN member into 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 Yugosla

7、v Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EU

8、ROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 80601-2-55:2018 ENational forewordThis British Stan

9、dard is the UK implementation of EN ISO 80601-2-55:2018. It is identical to ISO 80601-2-55:2018. It supersedes BS EN ISO 80601-2-55:2011, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/1, Breathing attachments and anaesthetic machines.A list of

10、 organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limit

11、ed 2018ISBN 978 0 580 87884 8ICS 11.040.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2018.Amendments/corrigenda issued since publicationDate Text a

12、ffectedBRITISH STANDARDBS EN ISO 80601-2-55:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80601-2-55 February 2018 ICS 11.040.10 Supersedes EN ISO 80601-2-55:2011English Version Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential perfor

13、mance of respiratory gas monitors (ISO 80601-2-55:2018) Appareils lectromdicaux - Partie 2-55: Exigences particulires relatives la scurit de base et aux performances essentielles des moniteurs de gaz respiratoires (ISO 80601-2-55:2018) Medizinische elektrische Gerte - Teil 2-55: Besondere Festlegung

14、en fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von berwachungsgerten fr Atemgase (ISO 80601-2-55:2018) This European Standard was approved by CEN on 18 January 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for gi

15、ving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning 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 of

16、ficial versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into 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

17、of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Sloveni

18、a, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserve

19、d worldwide for CEN national Members. Ref. No. EN ISO 80601-2-55:2018 EBS EN ISO 80601-2-55:2018EN ISO 80601-2-55:2018 (E) 3 European foreword This document (EN ISO 80601-2-55:2018) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Tech

20、nical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2018, and conflicting national st

21、andards shall be withdrawn at the latest by August 2021. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 80601-2-55:2

22、011. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. A

23、ccording to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germ

24、any, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this

25、 document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document h

26、as not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise

27、to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 80601-2-55:2018EN ISO 80601-2-55:2018 (E) 4 Table 1 Correlation between no

28、rmative references and dated EN and ISO standards Normative references as listed in 201.2 Equivalent dated International Standard EN ISO ISO 7000:2014 - ISO 7000:2014 ISO 7010:2011 EN ISO 7010:2012 ISO 7010:2011 ISO 14937:2009 EN ISO 14937:2009 ISO 14937:2009 ISO 15223-1:2016, corrected version 2017

29、 EN ISO 15223-1:2016 ISO 15223-1:2016, corrected version 2017 ISO 17664:2004 EN ISO 17664:2004 ISO 17664:2004 ISO 80601-2-13:2011 + Amd 1:2015 and Amd 2:a EN ISO 80601-2-13:2012a+ Amd 1: and Amd 2:aISO 80601-2-13:2011 + Amd 1:2015 and Amd 2:aISO 80369-1: 2010bEN ISO 80369-1:2010b ISO 80369-1:2010b I

30、SO 80369-2aEN ISO 80369-2:-aISO 80369-2aISO 80369-3 EN ISO 80369-3:2016 ISO 80369-3:2016 IEC 80369-5 EN ISO 80369-5:2016 IEC 80369-5:2016 ISO 80369-6 EN ISO 80369-6:2016 ISO 80369-6:2016 ISO 80369-7 EN ISO 80369-7:2017 ISO 80369-7:2017 ISO 80369-20 EN ISO 80369-20:2015 ISO 80369-20:2015 IEC 60601-1:

31、2005 + Amd 1:2012 EN 60601-1:2006 + Cor:2010 and + Amd 1:2013 IEC 60601-1:2005 + Amd 1:2012 IEC 60601-1-2:2014 EN 60601-1-2:2015 IEC 60601-1-2:2014 IEC 60601-1-6:2010 + Amd 1:2013 EN 60601-1-6:2010 + Amd 1:2015 IEC 60601-1-6:2010 + Amd 1:2013 IEC 60601-1-8:2006 + Amd 1:2012 EN 60601-1-8:2007 + Cor:2

32、010 and Amd 1:2013 IEC 60601-1-8:2006 + Amd 1:2012 IEC 60601-1-11:2015 EN 60601-1-11:2015 IEC 60601-1-11:2015 IEC 60601-1-12:2014 EN 60601-1-12:2015 IEC 60601-1-12:2014 IEC 60068-2-27:2008 EN 60068-2-27:2009 IEC 60068-2-27:2008 IEC 60068-2-64:2008 EN 60068-2-64:2008 IEC 60068-2-64:2008 IEC 60529:198

33、9 + Amd 1:1999 and Amd 2:2013 EN 60529:1991 + Amd 1:2000 and Amd 2:2013 IEC 60529:2001 aTo be published. bUnder revision. BS EN ISO 80601-2-55:2018EN ISO 80601-2-55:2018 (E) 5 Endorsement notice The text of ISO 80601-2-55:2018 has been approved by CEN as EN ISO 80601-2-55:2018 without any modificati

34、on. BS EN ISO 80601-2-55:2018EN ISO 80601-2-55:2018 (E) 6 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 c

35、oncerning the development of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Un

36、ion under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive and associated EFTA regulations. NOTE 1 Where a r

37、eference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized

38、or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references ac

39、cording to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex

40、I of Directive 93/42/EEC OJ L 169 Essential requirements of Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Remarks/Notes 7.3 201.11.6.4 Only the first sentence relating to design is partially addressed as follows: - only normal use is addressed; - only leaking or leaching of su

41、bstances is addressed. 7.6 201.11.6.5 only addressed with regard to - ingress of water or particulate matter and only addressed for normal use. BS EN ISO 80601-2-55:2018EN ISO 80601-2-55:2018 (E) 7 Essential requirements of Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Remarks

42、/Notes 8.1 201.11.6.6, 201.105 Only addressed as far as contamination resulting from reverse flow through the sampling tube and return flow. Easy handling andmanufacturing are not addressed. 8.7 201.7.2.17.101 9.1 201.7.2.101 d), e), f), g), h), 201.103 Only addressed by marking of the gas sampling

43、gas inlet and outlet including the related tubes of flow-direction-sensitive components that are operator-interchangeable 9.2 201.101, 202, 206 Covered for the effects of interfering gases and vapours, electromagnetic disturbances and usability. 10.1 201.12.1, 201.101 10.2 201.12.1.103, 201.12.1.104

44、, 206 Covered for the indication of units of measures for gas readings, for indication of the operating mode and for usability. 10.3 201.7.4.3 12.2 201.11.8.101 12.3 201.11.8.101 12.4 208 12.5 202 Covered with respect to electromagnetic disturbances 12.7.4 201.103 Covered for the risk of misconnecti

45、ng theexhaust port of a diverting RGM 12.8.2 201.104 Only the first sentence of BS EN ISO 80601-2-55:2018EN ISO 80601-2-55:2018 (E) 8 Essential requirements of Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Remarks/Notes ER 12.8.2 is covered 12.9 201.7, 201.12.1, 206 13.2 201.7

46、.2.3, 201.7.2.13.101, 201.7.2.17.101, 201.7.2.101 Covered with regard to marking of the equipment with the safety sign “Follow instructions for use” marking of the equipment, parts or accessories with the symbol for presence of latex, if applicable, and with the symbol for serial or lot number, for

47、gas inlet or outlet, with the appropriate symbol indicating the possible use in the magnetic resonance environment, and with the symbol for the use-by-date marking of the protective packaging of equipment, parts or accessories with the symbol for serial, type or batch number, and if applicable, for

48、presence of latex, for sterile conditions, and for single use Except for the requirement on marking with the safety sign “Follow instructions for use” all other requirements on marking with symbols are included as alternatives to corresponding requirements on marking using text elements 13.3 b) 201.

49、7.2.17.101 a) first dash Covered for marking of the packages of the equipment, parts or accessories with a description of the content BS EN ISO 80601-2-55:2018EN ISO 80601-2-55:2018 (E) 9 Essential requirements of Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Remarks/Notes 13.3 c) 201.7.2.17.101, a) 4th dash Covered for marking of the packages of the equipment, parts or accessories with text or symbol indicating sterile conditions, if applicable 13.3 d) 201.7.2.17.101, 201.7.2.101 I