BS EN 60601-2-34-2014 Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment《医疗电气设备 侵入性.pdf

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1、BSI Standards PublicationMedical electrical equipmentPart 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipmentBS EN 60601-2-34:2014National forewordThis British Standard is the UK implementation of EN 60601-2-34:2014. It isident

2、ical to IEC 60601-2-34:2011. It supersedes BS EN 60601-2-34:2001,which will be withdrawn on 27 June 2017.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment.A list of organizatio

3、ns represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 97

4、8 0 580 59725 1ICS 11.040.55Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2014.Amendments/corrigenda issued since publicationDate Text affectedBRITISH ST

5、ANDARDBS EN 60601-2-34:2014EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 60601-2-34 June 2014 ICS 11.040.55 Supersedes EN 60601-2-34:2000 English Version Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure mo

6、nitoring equipment (IEC 60601-2-34:2011) Appareils lectromdicaux - Partie 2-34: Exigencesparticulires pour la scurit de base et les performancesessentielles des appareils de surveillance de la pressionsanguine prleve directement (CEI 60601-2-34:2011) Medizinische elektrische Gerte - Teil 2-34: Beson

7、dereFestlegungen fr die Sicherheit einschlielich derwesentlichen Leistungsmerkmale von invasiven Blutdruck-berwachungsgerten (IEC 60601-2-34:2011) This European Standard was approved by CENELEC on 2011-05-16. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipula

8、te the conditions for giving 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 CENELEC member. This European

9、Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CENELEC members

10、are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway,

11、 Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Mar

12、nix 17, B-1000 Brussels 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-34 E BS EN 60601-2-34:2014EN 60601-2-34:2014 - 2 - Foreword The text of document 62D/906/FDIS, future edition 3 of IEC 60601-2-34, prepared by SC 6

13、2D,“Electromedical equipment“, of IEC TC 62, “Electrical equipment in medical practice“, was submitted tothe IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-34:2014. The following dates are fixed: latest date by which the document has to be implemented at national level bypublication

14、 of an identical national standard or by endorsement (dop) 2014-12-27 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2017-06-27 This document supersedes EN 60601-2-34:2000. EN 60601-2-34:2014 was revised to align structurally with EN 60601-1:2006

15、. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text oftables is also in a smaller type. TERMS DEFI

16、NED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of allsubdivisions (e.g. Clause 7 includes subclau

17、ses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. References to subclauses within this particular standard are

18、by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combinationof the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,Part 2. For the purposes of this standard, th

19、e auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with thisstandard; “should” means that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this standard; BS EN 60601-2-34:2014- 3 - EN 60601-2-34:2014

20、“may” is used to describe a permissible way to achieve compliance with a requirement or test. This document has been prepared under a mandate given to CENELEC by the European Commissionand the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationsh

21、ip with EU Directive(s) see informative Annex ZZ, which is an integral part of thisdocument. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patentrig

22、hts. Endorsement notice The text of the International Standard IEC 60601-2-34:2011 was approved by CENELEC as a EuropeanStandard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated: IEC 80601-2-30 NOTE Harmonized as EN 80

23、601-2-30. BS EN 60601-2-34:2014EN 60601-2-34:2014 - 4 - Annex ZA (normative) Normative references to international publicationswith their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edit

24、ion cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of the general standard applies, exc

25、ept as follows: Year Publication Title EN/HD Year Replacement:IEC 60601-1-2(mod)2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 20072

26、010IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests andguidance for alarm systems in medicalelectrical equipment and medical electricalsystems EN 60601-1-8 + corr. March 2007

27、2010Addition: IEC 60601-2-2 2009 Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of highfrequency surgical equipment and highfrequency surgical accessories EN 60601-2-2 + A1120092011IEC 60601-2-27 - Medical electrical equipment - Part 2-27:

28、 Particular requirements for the basic safety and essential performance ofelectrocardiographic monitoring equipment EN 60601-2-271)- IEC 60601-2-49 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance ofmultifunction patient monitoring eq

29、uipment EN 60601-2-491)- ISO 15223-1 2007 Medical devices - Symbols to be used withmedical device labels, labelling andinformation to be supplied - Part 1: General requirements EN ISO 15223-1 2012 1)At draft stage. BS EN 60601-2-34:2014- 5 - EN 60601-2-34:2014 Annex ZZ (informative) Coverage of Esse

30、ntial Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and within its scope the standard covers allrelevant essential requirements as given in Annex I of the EC Directive 93/42/EE

31、C except as follows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this pa

32、rticular standard. 201.2 Normative references Clause 2 of the general standard applies, except as follows: Replacement: IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requir

33、ements and tests IEC 60601-1-8:2006, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Addition: BS EN 6

34、0601-2-34:201460601-2-34 IEC:2011 9 IEC 60601-2-2:2009, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC 60601-2-27, Medical electrical equipment Part 2-27: P

35、articular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment2IEC 60601-2-49, Medical electrical equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment3ISO 15223-1:

36、2007 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements NOTE Informative references are listed in the bibliography beginning on page 61. 201.3 Terms and definitions NOTE An index of defined terms is found beginning on

37、page 61. For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 apply, except as follows: Replacement: 201.3.63 MEDICAL ELECTRICAL EQUIPMENT ME EQUIPMENT Addition: INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (ME EQUIPMENT) device including associated TRANSDUCERS, tha

38、t is used for internal measurement or monitoring of circulatory system pressures Replacement: 201.3.8 APPLIED PART TRANSDUCER, including its associated catheter and any fluid-filled system Additional definitions: 201.3.201 CATHETER TIP TRANSDUCER TRANSDUCER mounted at, or close to, the tip of a cath

39、eter and intended for insertion into the cardiovascular system 201.3.202 DOME means for hydraulically coupling the PATIENTS blood pressure to a TRANSDUCER external to the PATIENT 2Third edition, to be published. 3Second edition, to be published. BS EN 60601-2-34:2014 10 60601-2-34 IEC:2011 201.3.203

40、 NOMINAL SENSITIVITY ratio of the change in TRANSDUCER output to a change of the value of the pressure at any selected pressure range 201.3.204 TRANSDUCER device for converting pressure into an electrical signal 201.4 General requirements Clause 4 of the general standard applies, except as follows:

41、201.4.3 ESSENTIAL PERFORMANCE Addition: 201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements Additional ESSENTIAL PERFORMANCE requirements for INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT are found in subclauses listed in Table 201.101. Table 201.101 ESSENTIAL PERFORMANCE requirements Requireme

42、nt Subclause Defibrillator protection 201.8.5.5.1 Accuracy of pressure measurements 201.12.1.101 Electrosurgery interference 202.6.2.101 Delays to or from a DISTRIBUTED ALARM SYSTEM 208.6.4.2 PHYSIOLOGICAL ALARM CONDITIONS, ALARM LIMITS and delay time of physiological ALARM SIGNALS 208.6.6.2.101 Det

43、ection of TRANSDUCER and TRANSDUCER cable fault 208.6.6.2.102 Detection of disconnected catheter 208.6.6.2.103 201.5 General requirements for testing of ME EQUIPMENT Clause 5 of the general standard applies, except as follows: 201.5.4 Other conditions Addition: Unless otherwise stated, tests shall b

44、e carried out with the ACCESSORIES specified by the MANUFACTURER. For ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE, if the test result is affected by the INTERNAL ELECTRICAL POWER SOURCE voltage, then the test shall be performed using the least favourable INTERNAL ELECTRICAL POWER SOURCE vo

45、ltage specified by the MANUFACTURER. If necessary for the purpose of conducting the test, an external battery or d.c. power supply may be used to provide the necessary test voltage. The values used in test circuits, unless otherwise specified, shall have at least an accuracy as given below: resistor

46、s: 1 %; BS EN 60601-2-34:201460601-2-34 IEC:2011 11 capacitors: 10 %; inductors: 10 %; test voltages: 1 % 201.5.8 * Sequence of tests Amendment: Tests called for in 201.8.5.5.1 of this particular standard and in 8.5.5 of the general standard shall be carried out prior to the LEAKAGE CURRENT and diel

47、ectric strength tests described in subclauses 8.7 and 8.8 of the general standard and prior to the tests specified in subclause 201.12.1.101. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies, except as follows: 201.6.2 * Protection against electric shock R

48、eplacement of the last paragraph: APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of the general standard). APPLIED PARTS shall be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5 of the general standard). 201.6.6 Mode of operation Replacement: ME EQUIPMENT

49、shall be classified for CONTINUOUS OPERATION (see 7.2.11). 201.7 ME EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows: 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 201.7.2.10 APPLIED PARTS Addition: If fulfilment of TYPE CF APPLIED PART isolation depends on the TRANSDUCER, then symbol 27, Table D.1 of the general standard, shall be marked on the TRANSDUCER. 201.7.2.17 * Protective p