1、BRITISH STANDARD Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems The European Standard EN 60601-247:2001 has the status of a British Standard ICs 11.040.55 BS EN 6060 1-2-47: 2001 IEC 6060 1-2
2、-47: 2001 Wk present to the responsible international/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. - A list of organizations represented on t
3、his 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 IEC 60027-1. For a period oftime during the change over from one numbering system to the other, publicatio
4、ns may contain identifiers from both systems. Cr oss-r e fer enc e s The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by
5、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 responsible for their correct application. Compliance with a British Standard does not of itself confer immun
6、ity from legal obligations. 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 indicates when the document was last issued. O BSI 27 November 200 1 ISBN O 580 38712 7 EUR
7、OPEAN STANDARD EN 60601 -2-47 NORME EUROPENNE EUROPISCHE NORM October 2001 ICs 11.040.55 English version Med i cal e lec t r i cal eq u i pme n t Part 2-47: Particular requirements for the safety, including essential performance, of am bu latory elect rocardi og rap h ic systems (IEC 60601-2-4712001
8、) Appareils lectromdicaux Medizinische elektrische Gerte Partie 2-47: Rgles particulires de scurit et performances essentielles des systmes dlectrocardiographie am bulatoires (CE1 60601 -2-4712001) System en Teil 2-47: Besondere Festlegungen fr die Sicherheit einschlielich wesentlicher Leistungsmerk
9、male von am bu lanten elektro kard iograp h ischen (IEC 60601-2-4712001) This European Standard was approved by CENELEC on 2001-10-01. CENELEC members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a nationa
10、l 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 CENELEC member. This European Standard exists in three official versions (English, French, German). A version in a
11、ny 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 versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Fi
12、nland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotech
13、nische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels O 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 Page 2 EN 60601-2-472001 Foreword The text of document 62D/408/FDIS, future edition
14、 1 of IEC60601-2-47, 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 fixed: - latest date by which the EN has to b
15、e implemented at national level by publication of an identical national standard or by endorsement - latest date by which the national standards conflicting with the EN have to be withdrawn (dop) 2002-07-01 (dow) 2004-1 0-01 Annexes designated “normative“ are part of the body of the standard. Annexe
16、s 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, compliance with which can be tested, and defin
17、itions: roman type; - fesf specificafions: ifalic type; - - TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL explanations, advice, notes, general statements and exceptions: smaller roman type; CAPITALS. Endorsement notice The text of the International Standard IEC
18、 60601-2-47:2001 was approved by CENELEC as a European Standard without any modification. O BSI 27 November 2001 Page 3 EN 60601-2-472001 CONTENTS o INTRODUCTION 5 SECTION ONE -GENERAL 1 Scope and object 2 Terminology and definitions 5 Classification 6 Identification, marking and documents . 9 SECTI
19、ON TWO - ENVIRONMENTAL CONDITIONS 10 Environmental conditions 1 O SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 20 Dielectric strength . 11 SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength 11 SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE
20、RAD IATI ON 36 Electromagnetic compatibility 12 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
21、Accuracy of operating data . 14 Protection against hazardous output . 21 50 51 SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN - CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly 29 O BSI 27 November 2001 Page 4 EN 60601-2-472001 Appendix L (norma
22、tive) 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 (informative) Other international publications mention
23、ed in this standard with the references of the relevant European publications . 45 Figure 101 . Test set-up for conductive emission test according 36.201 . 1 30 Figure 102 . Test set-up for radiated emission and radiated immunity test according to 36.201.1 and 36.202.2. 31 Figure 103 - Test signal f
24、or input dynamic range test according to 51.5.1 32 Figure 104 - General test circuit for 51.5 . 32 33 34 Figure 105 - Test circuit for common mode rejection according to 51.5.3 Figure 106 - Test circuit for pacemaker pulse tolerance according to 51.5.1 1 Table 101 . LEAD colour codes 9 Table 102 . R
25、eporting requirements for standard analyser outputs 15 Table 103 . Reporting requirements for optional analyser outputs 16 Table 104 . Beat-by-beat matrix 18 Index of defined terms . 44 O BSI 27 November 2001 Page 5 EN 60601-2-472001 INTRODUCTION This Particular Standard concerns the Safety Of AMBUL
26、ATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements IEC 60601-1 (second edition 1988): Medical elecfrical equiprnenf - Parf 1: General requirernenfs for safefy, as amended by its amendment 1 (1991) and its amendment 2 (1995), hereinafter referred to as the General Standard. The requirement
27、s 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 facilitate the proper app
28、lication 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 subclause number indicates th
29、at some explanatory notes are given in annex AA of this Particular Standard. O BSI 27 November 2001 Page 6 EN 60601-2-472001 MEDICAL ELECTRICAL EQUIPMENT - Part 2-47: Particular requirements for the safety, including essential perform an ce, of am bu I at o ry elect roca rd i og rap h i c systems SE
30、CTION 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 Addifion: This Particular Standard specifies the particular safety requirements for AMBULATORY EL
31、ECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.1 01. 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 first record and store
32、 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-analysis of the ECG. The
33、 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 electrical equipment c
34、overed 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 Replacemenf: The object of this Particular Standard is to esta
35、blish particular requirements for the safety, i ncl ud i ng eSS entia I perform a IlCe, Of AM B U LATO RY E LECTROCARD I OG RAP H I C SYSTEM S. O BSI 27 November 2001 Page 7 EN 60601-2-472001 1.3 Particular Standards Addifion: This Particular Standard refers to IEC 60601-1 (1988): Medical elecfrical
36、 equipmenf - Parf 1: General requiremenfs for safefy, as amended by its amendment 1 (1991) and its amendment 2 (1 995). 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). The numberin
37、g 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 text of this Pa
38、rticular 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, subclauses, tables and
39、 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 taken together. Wh
40、ere 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 relevant, is n
41、ot to be applied, a statement to that effect is given in this Particular Standard. 1.5 Collateral Standards Addifion: IEC 60601-1-2:1993, Medical elecfrical equipmenf - Parf 1: General requiremenfs for safefy - 2. Collaferal sfandard: Elecfromagnefic compafibilify - Requiremenfs and fesfs “2 Termino
42、logy and definitions This clause of the General standard applies except as follows: Addifional definifions: 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 referred to a
43、s Holter monitoring equipment after its inventor Dr. Norman Holter. O BSI 27 November 2001 Page 8 EN 60601-2-472001 2.102 AMBULATORY RECORDER recording EQUIPMENT worn or carried by the PATIENT including associated ELECTRODES and cables for recording or recording and analysing heart action potentials
44、 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 IEC 60601-2-25:1993, defi
45、nition 2.1011 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 body to detect heart act
46、ion voltage in combination with another means IEC 60601-2-25:1993, definition 2.1041 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 2.1071 2.108 PATIENT CABL
47、E multiwire cable and associated connector(s) to connect the ELECTRODES to the AMBULATORY IEC 60601-2-25:1993, definition 2.1091 RECORDER 2.1 O9 LEAD WIRE(S) cable connected between the ELECTRODE and the AMBULATORY RECORDER. 2.110 EQUIPMENT which performs continuous analysis and/or recording of the
48、ECG CONTINUOUS RECORDER O BSI 27 November 2001 Page 9 EN 60601-2-472001 Channel 1 Channel 2 Channel 3 NEUTRAL ELECTRODE 5 Classification ELECTRODE Code la Positive ELECTRODE green Negative ELECTRODE red Positive ELECTRODE white Negative ELECTRODE yellow Positive ELECTRODE orange Negative ELECTRODE b
49、lue black This clause of the General Standard applies except as follows: 5.6 Amendmenf: Delete all but CONTINUOUS OPERATION. 6 Identification, marking and documents This clause of the General Standard applies except as follows: 6.1 Marking on the outside Of EQUIPMENT or EQUIPMENT parts Addifional ifem: aa) LEAD identification The LEAD(S) shall be permanently marked in such a manner that the proper LEAD can be directly determined at both the ELECTRODE attachment end, and so constructed or marked as to avoid incorrect connection to the EQUIPMENT. If
