BS EN 60601-2-51-2003 Medical electrical equipment - Particular requirements for safety - Particular requirements for safety including essential performance of recording and analyso.pdf

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1、BRITISH STANDARD BS EN 60601-2-51:2003 Medical electrical equipment Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs The European Standard EN 60601-2-51:2003 has the status of a British Stan

2、dard ICS 11.040.55 BS EN 60601-2-51:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 15 October 2003 BSI 15 October 2003 ISBN 0 580 42728 5 National foreword This British Standard is the official English language version of EN 60601-2-51:

3、2003. It is identical with IEC 60601-2-51:2003. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/4, Electromedical equipment, which has the responsibility to: A list of organizations represented on

4、 this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or b

5、y using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immun

6、ity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Sum

7、mary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 83 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEAN STANDARD

8、EN 60601-2-51 NORME EUROPENNE EUROPISCHE NORM July 2003 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2003 CENELEC - All right

9、s of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-51:2003 E ICS 11.040.55 English version Medical electrical equipment Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel an

10、d multichannel electrocardiographs (IEC 60601-2-51:2003) Appareils lectromdicaux Partie 2-51: Rgles particulires de scurit et performances essentielles des lectrocardiographes enregistreurs et analyseurs mono et multi-canaux (CEI 60601-2-51:2003) Medizinische elektrische Gerte Teil 2-51: Besondere F

11、estlegungen fr die Sicherheit, einschlielich wesentlicher Leistungsmerkmale von aufzeichnenden und interpretierenden Einkanal- und Mehrkanal- Elektrokardiographen (IEC 60601-2-51:2003) This European Standard was approved by CENELEC on 2003-04-01. CENELEC members are bound to comply with the CEN/CENE

12、LEC 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 concerning such national standards may be obtained on application to the Central Secretariat or to any C

13、ENELEC 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 CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versio

14、ns. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EN

15、60601-2-51:2003 - 2 - Foreword The text of document 62D/469/FDIS, future edition 1 of IEC 60601-2-51, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-51 on 2

16、003-04-01. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2004-02-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2006-04-01

17、 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annexes GG, HH, ZA and ZB are normative, annexes AA to FF and annex II are informative. Annexes ZA and ZB have been added by CENELEC. In this parti

18、cular standard, the following print types are used: requirements, compliance with which can be tested, and definitions: roman type; notes, explanations, advice, introductions, general statements, exceptions and references: small roman type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2

19、 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS. _ Endorsement notice The text of the International Standard IEC 60601-2-51:2003 was approved by CENELEC as a European Standard without any modification. _ Page2 EN60601251:2003CONTENTS INTRODUCTION.5 SECTION ONE GENERAL 1 Scope an

20、d object6 2 Terminology and definitions 7 4 General requirements for tests10 6 Identification, marking and documents 11 SECTION TWO ENVIRONMENTAL CONDITIONS SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZA

21、RDS FROM UNWANTED OR EXCESSIVE RADIATION SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy

22、of operating data13 50.101 Automated measurements on ECGs (for ANALYSING ELECTROCARDIOGRAPHS).13 50.102 Automated ECG interpretation (for ANALYSING ELECTROCARDIOGRAPHS)18 51 Protection against hazardous output .22 51.101 LEADS22 51.102 Input circuit .26 51.103 CALIBRATION 27 51.104 SENSITIVITY .28 5

23、1.105 Reduction of the effects of unwanted external voltages28 51.106 Base-line.29 51.107 Distortion 31 51.108 Printing, electronic storage and transmission.33 51.109 Use with cardiac pacemakers35 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL RE

24、QUIREMENTS 56 Components and general assembly36 56.7 BATTERIES.36 Appendix L (normative) References Publications mentioned in this standard42 Annex AA (informative) General guidance and rationale43 Annex BB (informative) ELECTRODES, their positions, identifications and colour codes .50 Annex CC (inf

25、ormative) LEADS and their identification (other than described in 51.101) .52 Annex DD (informative) Polarity of PATIENT LEADS (other than those specified in 51.101).54 Annex EE (informative) Additional marking of electrodes 55 Annex FF (informative) Noise.57 Page3 EN60601251:2003Annex GG (normative

26、) Definitions and rules for the measurement of ELECTROCARDIOGRAMS .59 Annex HH (normative) Calibration and test data sets 65 Annex II (informative) CTS test atlas 67 Annex ZA (normative) Normative references to international publications with their corresponding European publications 79 Annex ZB (no

27、rmative) Other international publications mentioned in this standard with the references of the relevant European publications.80 Bibliography81 INDEX OF DEFINED TERMS 82 Figure 101 Electrode position according to Frank (see Table 101) 37 Figure 102 Polarity of patient leads (see 51.101.1) .37 Figur

28、e 103 Test of weighting networks and input impedance (see 51.101.2.2 and 51.102.1). 37 Figure 104 Test of common mode rejection (see 51.105.1 and 51.106.4) 38 Figure 105 Triangular waveforms for test E of Table 114 (see 51.107.1.1.1) .39 Figure 106 Input impulse signal (dashed trace) and cardiograph

29、 response (continuous trace) (see 51.107.1.1.2) 39 Figure 107 Circuit for test of linearity (see 51.107.2).40 Figure 108 Result of linearity test (see 51.107.2) 40 Figure 109 Test of rectangular coordinates (see 51.108.4.1).41 Table 101 ELECTRODES and NEUTRAL ELECTRODES, their position, identificati

30、on and colour code.12 Table 102 Offset voltage for ST and T amplitude reference values if the signals are fed through a first order high pass FILTER with a TIME CONSTANT of 3,2 s 15 Table 103 Acceptable mean differences and standard deviations for global intervals and Q-, R-, S-durations on calibrat

31、ion and analytical ECGs.16 Table 104 Acceptable mean differences and standard deviations for global durations and intervals for biological ECGs 17 Table 105 Disclosed changes of measurements caused by NOISE on ECGs according to Table HH.317 Table 106 Tabulation of test results18 Table 107 Format for

32、 disclosure of accuracy measures for diagnostic interpretative statements.21 Table 108 Format for disclosure of accuracy measures for rhythm interpretative statements 22 Table 109 Connection of ELECTRODES for a particular LEAD .23 Table 110 LEADS and their identification (nomenclature and definition

33、) 23 Table 111 LEAD networks for Goldberger and Wilson LEADS 25 Table 112 LEAD network for Frank LEADS.26 Table 113 Test of input impedance Positions of LEAD SELECTOR, connection of LEAD ELECTRODES and peak to valley deflection in mm with S1 open.27 Table 114 Frequency response.31 Table HH.1 Calibra

34、tion and analytical ECGs.65 Table HH.2 Data set for testing of measurement and wave recognition accuracy of biological data 100 ECGs of the CSE-study66 Table HH.3 Data set for testing NOISE stability 66 Page4 EN60601251:2003INTRODUCTION This Particular Standard concerns additional safety of recordin

35、g and analysing single channel and multichannel electrocardiographic equipment. It amends and supplements IEC 60601-1 (second edition, 1988), including its amendments 1 (1991) and 2 (1995) hereinafter referred to as the General Standard. The requirements of this Particular Standard take priority ove

36、r those of the General Standard, entitled Medical electrical equipment Part 1: General requirements for safety. A “General guidance and rationale” for the requirements of this Particular Standard is included in Annex AA. It is considered that a knowledge of the reasons for these requirements will no

37、t only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this Standard. An asterisk (*) by a clause

38、or subclause number indicates that some explanatory notes are given in Annex AA. Page5 EN60601251:2003MEDICAL ELECTRICAL EQUIPMENT Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs SECTION ON

39、E GENERAL The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: *1.1 Scope Addition: This Particular Standard specifies requirements for the safety, including essential performance

40、, of RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS as defined in 2.101, 2.111, 2.117, 2.123, 2.126, hereinafter referred to as EQUIPMENT. The EQUIPMENT may be attended or unattended. This Particular Standard complements IEC 60601-2-25 and its Amendment 1 (1999). 1.2 Obj

41、ect Replacement: The object of this Particular Standard is to establish particular requirements, in addition to the requirements of IEC 60601-2-25, for the safety, including essential performance of RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS. These requirements shall

42、 apply particularly to RECORDING ELECTROCARDIOGRAPHS; ELECTROCARDIOGRAPHS which are part of other MEDICAL ELECTRICAL EQUIPMENT, for example exercise testing systems, if this EQUIPMENT is used to record ECGs for diagnostic purposes; ELECTROCARDIOGRAPHS which are used as output units for ECG data base

43、 management systems or ELECTROCARDIOGRAPHS which are used as output units located at other places than the recording unit; ANALYSING ELECTROCARDIOGRAPHS, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplit

44、udes) and diagnostic statements from the ECG; those parts of PATIENT monitors or other specialised ELECTROCARDIOGRAPHS that are capable of performing the functions of the ANALYSING ELECTROCARDIOGRAPHS. This standard shall not apply to Holter ELECTROCARDIOGRAPHS, invasive electrocardiography, PATIENT

45、 monitoring systems and high-resolution ELECTROCARDIOGRAPHS (e.g. HIS bundle ELECTROCARDIOGRAPHS, ELECTROCARDIOGRAPHS for late potential detection) other than stated above. Page6 EN60601251:2003 1.3 Particular Standards Addition: This Particular Standard refers to IEC 60601-1:1988, Medical electrica

46、l equipment Part 1: General requirements for safety, as amended by its Amendment 1 (1991) and Amendment 2 (1995), hereafter referred to as the General Standard, and to IEC 60601-2-25:1993, Medical electrical equipment Part 2-25: Particular requirements for the safety of electrocardiographs and its A

47、mendment 1 (1999). The General Standard also takes into account IEC 60601-1-2:1993, Medical electrical equipment Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibility Requirements and tests, and IEC 60601-1-4:1996, Medical electrical equipment Part 1: General

48、requirements for safety 4. Collateral Standard: Programmable electrical medical systems. The term “this Standard” is used to make reference to the General Standard and this Particular Standard taken together. The numbering of sections, clauses or subclauses of this Particular Standard corresponds wi

49、th 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 the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard. “Addition” means that the text of this Particular Standard is additional to t