BS EN 60601-2-47-2001 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety including essential performance of ambulatory elect.pdf

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1、BRITISH STANDARD BS EN 60601-2-47: 2001 IEC 60601-2-47: 2001 Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems The European Standard EN 60601-2-47:2001 has the status of a British Standard ICS 1

2、1.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 60601-2-47:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strat

3、egy Committee on 27 November 2001 BSI 27 November 2001 ISBN 0 580 38712 7 National foreword This British Standard is the official English language version of EN 60601-2-47:2001. It is identical with IEC 60601-2-47:2001. The UK participation in its preparation was entrusted to Technical Committee CH/

4、96, Patient Monitoring Equipment, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as

5、 IEC 60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI

6、 Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are respons

7、ible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep t

8、he UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 45, and a back cover. The BSI copyright date displayed in this document indica

9、tes when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEAN STANDARD EN 60601-2-47 NORME EUROPENNE EUROPISCHE NORM October 2001 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Ko

10、mitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-47:2001 E ICS 11.040.55 English version Medical electrical equipment Part 2

11、-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001) Appareils lectromdicaux Partie 2-47: Rgles particulires de scurit et performances essentielles des systmes dlectrocardiographie ambulatoires (CEI 60601-2-47:

12、2001) Medizinische elektrische Gerte Teil 2-47: Besondere Festlegungen fr die Sicherheit einschlielich wesentlicher Leistungsmerkmale von ambulanten elektrokardiographischen Systemen (IEC 60601-2-47:2001) This European Standard was approved by CENELEC on 2001-10-01. CENELEC members are bound to comp

13、ly 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 concerning such national standards may be obtained on application to the Central Sec

14、retariat or to any CENELEC 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

15、 the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Foreword The t

16、ext of document 62D/408/FDIS, future edition 1 of IEC 60601-2-47, 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 60601-2-47 on 2001-10-01. The following dates were

17、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) 2002-07-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2004-10-01 Annexes designated “normative“ are

18、part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annex ZA is normative and annexes AA and ZB are informative. Annexes ZA and ZB have been added by CENELEC. In this standard, the following print types are used: requirements, complian

19、ce with which can be tested, and definitions: roman type; explanations, advice, notes, general statements and exceptions: smaller roman type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS. _ Endorsement notice The text

20、 of the International Standard IEC 60601-2-47:2001 was approved by CENELEC as a European Standard without any modification. _ Page2 EN60601247:2001 BSI27November200160601-2-47 IEC:2001(E) 3 CONTENTS INTRODUCTION 5 SECTION ONE GENERAL 1 Scope and object. 6 2 Terminology and definitions . 7 5 Classifi

21、cation 9 6 Identification, marking and documents . 9 SECTION TWO ENVIRONMENTAL CONDITIONS 10 Environmental conditions10 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 20 Dielectric strength.11 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength11 SECTION FIVE PROTECTIO

22、N AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 36 Electromagnetic compatibility12 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

23、 PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data .14 51 Protection against hazardous output .21 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly 29 Page3 EN60601247:2001 BSI27Novembe

24、r2001 4 60601-2-47 IEC:2001(E) Appendix L (normative) References Publications mentioned in this standard.35 Annex AA (informative) Guidance and rationale .36 Annex ZA (normative) Normative references to international publications with their corresponding European publications 45 Annex ZB (informativ

25、e) Other international publications mentioned in this standard with the references of the relevant European publications.45 Figure 101 Test set-up for conductive emission test according 36.201.130 Figure 102 Test set-up for radiated emission and radiated immunity test according to 36.201.1 and 36.20

26、2.2.31 Figure 103 Test signal for input dynamic range test according to 51.5.1 32 Figure 104 General test circuit for 51.5 .32 Figure 105 Test circuit for common mode rejection according to 51.5.3.33 Figure 106 Test circuit for pacemaker pulse tolerance according to 51.5.11 .34 Table 101 LEAD colour

27、 codes 9 Table 102 Reporting requirements for standard analyser outputs 15 Table 103 Reporting requirements for optional analyser outputs16 Table 104 Beat-by-beat matrix18 Index of defined terms.44 Page4 EN60601247:2001 BSI27November200160601-2-47 IEC:2001(E) 5 INTRODUCTION This Particular Standard

28、concerns the safety of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements IEC 60601-1 (second edition 1988): Medical electrical equipment Part 1: General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2 (1995), hereinafter referred to as the General S

29、tandard. The requirements of this Particular Standard take priority over those of the General Standard. 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 not only f

30、acilitate 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 or subcl

31、ause number indicates that some explanatory notes are given in annex AA of this Particular Standard. Page5 EN60601247:2001 BSI27November2001 6 60601-2-47 IEC:2001(E) MEDICAL ELECTRICAL EQUIPMENT Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electro

32、cardiographic 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 General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard specifies the particular safety require

33、ments for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may

34、first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-an

35、alysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories. If the ambulatory electrocardiographic system offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. Medical

36、electrical equipment covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, intermittent event recorders). 1.2 Object Replacement: The object of this Particul

37、ar Standard is to establish particular requirements for the safety, including essential performance, of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. Page6 EN60601247:2001 BSI27November200160601-2-47 IEC:2001(E) 7 1.3 Particular Standards Addition: This Particular Standard refers to IEC 60601-1 (1988): M

38、edical electrical equipment Part 1: General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2 (1995). For brevity, IEC 60601-1 is referred to in this Particular Standard either as the General Standard including its collateral standards or as the General Requirement(s)

39、. The numbering of sections and subclauses of this Particular Standard corresponds to that of the General Standard. Changes to the text of the General Standard are specified by the following words: Replacement means that the clause or subclause of the General Standard is replaced completely by the t

40、ext of this Particular Standard. Addition means that the text of this Particular Standard is additional to the requirements of the General Standard. Amendment means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Clauses, subclaus

41、es, tables and figures which are additional to those of the General Standard are numbered starting from 101, additional appendices are lettered AA, BB, etc., and additional items aa), bb), etc. The term this Standard is used to make reference to the General Standard and this Particular Standard take

42、n together. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies without modification; where it is intended that any part of the General Standard, although possibly

43、relevant, is not to be applied, a statement to that effect is given in this Particular Standard. 1.5 Collateral Standards Addition: IEC 60601-1-2:1993, Medical electrical equipment Part 1: General requirements for safety 2. Collateral standard: Electromagnetic compatibility Requirements and tests *2

44、 Terminology and definitions This clause of the General standard applies except as follows: Additional definitions: 2.101 AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM (EQUIPMENT) AMBULATORY RECORDER and a PLAYBACK EQUIPMENT, both of which may contain an analysis function NOTE This EQUIPMENT is often refer

45、red to as Holter monitoring equipment after its inventor Dr. Norman Holter. Page7 EN60601247:2001 BSI27November2001 8 60601-2-47 IEC:2001(E) 2.102 AMBULATORY RECORDER recording EQUIPMENT worn or carried by the PATIENT including associated ELECTRODES and cables for recording or recording and analysin

46、g heart action potentials 2.103 PLAYBACK EQUIPMENT EQUIPMENT for monitoring and documenting functions into which data from the RECORDER is fed NOTE This EQUIPMENT is usually stationary and commonly includes computing facilities. 2.104 ELECTROCARDIOGRAM (ECG) visual record of heart action potentials

47、IEC 60601-2-25:1993, definition 2.101 2.105 LEAD ELECTRODE and LEAD WIRE combination(s) used for a certain recording of ECG. Examples: Einthoven limb LEAD II, Unipolar chest LEAD V5 IEC 60601-2-25:1993, definition 2.103, modified 2.106 PATIENT ELECTRODE means in contact with a specified part of the

48、body to detect heart action voltage in combination with another means IEC 60601-2-25:1993, definition 2.104 2.107 NEUTRAL ELECTRODE reference point for differential amplifiers and/or interference suppression circuits, not forming part of any ELECTROCARDIOGRAPH LEAD IEC 60601-2-25:1993, definition 2.

49、107 2.108 PATIENT CABLE multiwire cable and associated connector(s) to connect the ELECTRODES to the AMBULATORY RECORDER IEC 60601-2-25:1993, definition 2.109 2.109 LEAD WIRE(S) cable connected between the ELECTRODE and the AMBULATORY RECORDER. 2.110 CONTINUOUS RECORDER EQUIPMENT which performs continuous analysis and/or recording of the ECG. Page8 EN60601247:2001 BSI