EN 60601-2-40-1998 en Medical Electrical Equipment Part 2-40 Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment《医疗电气设备 第2-40部分 肌电图仪和激发响应设备安全的特.pdf

1、BRITISH STANDARD Medical electrical equipment - Part 2-40: Particular requirements for safety - Specification for electromyographs and evoked response equipment The European Standard EN 60601-2401998 has the status of a British Standard ICs 11.040.50 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMI

2、TTED BY COPYRIGHT LAW BS EN 60601-2-40: 1998 IEC 60601-2-40: 1998 1998 BS 5724-2.40: BS EN 60601-2-401998 National foreword This British Standard is the English language version of EN 60601-2-40:1998. It is identical with IEC 60601-2-401998. The K p - present to the responsible intemationaUEuropean

3、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 this committee can be obtained on request to its secrekxy. From

4、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 of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references

5、Attention is drawn to the fact that CEN and CENELEC Standards nody include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BS

6、I Standards Catalogue under the section entitled “intemationai 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 responsi

7、ble for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside hnt cover, the EN title page, pages 2 to 20, an inside back cover and a back cover. This British Standard

8、, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 16 June 1998 0 BSI 1998 ISBN O O80 29950 3 Amendments issued since publication I Text AmdNo. Date EUROPEAN STANDARD NORME EUROPENNE

9、 EUROPISCHE NORM EN 6060 I -2-40 April 1998 ICC 1 1.040.50 Descriptors: Medical electrical equipment, electromyographs, evoked response equipment, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental condit

10、ions English version Medical electrical equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601 -2-40: 1998) Appareils lectromdicaux Medizinische elektrische Gerte Partie 2-40: Rgles particulires de scurit pour les lectromyographes et

11、les appareils potentiel voqu Teil 2-40: Besondere Festlegungen fr die Sicherheit von Elektromyographen und Gerten fr evozierte Potentiale (CE1 60601 -2-40: 1998) (IEC 60601 -2-40: 1998) This European Standard was approved by CENELEC on 1998-04-01. CENELEC members are bound to comply with the CENICEN

12、ELEC 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

13、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 the official versi

14、ons. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrot

15、echnicai Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Centrai Secretariat: rue de Stassart 35, B - 1050 Brussels 1998 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No.

16、 EN 60601-2-40:1998 E Page 2 EN 60601-2-40:1998 Foreword The text of document 62D/255/FDIS, future edition 1 of IEC 60601-2-40, 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 CEN

17、ELEC as EN 60601 -2-40 on 1998-04-01. 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) 1999-01-01 - latest date by which the national standards conflicting with the EN have t

18、o be withdrawn (dow) 200 1 -0 1 -0 1 Annexes designated “normative“ are 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. Endo

19、rsement notice The text of the International Standard IEC 60601 -2-40: 1 998 was approved by CENELEC as a European Standard without any modification. Page 3 EN 60601-2-40:1998 CONTENTS Page . INTRODUCTION 5 SECTION ONE: GENERAL Clause 1 2 Terminology and definitions . 7 5 Classification 8 6 Identifi

20、cation, marking and documents . 8 7 Power input . 10 Scope and object . 6 SECTION TWO: ENVIRONMENTAL CONDITIONS SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 14 Requirements related to classification . 11 20 Dielectric strength . 11 SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS SECT

21、ION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 36 Electromagnetic compatibility 11 SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES ANDOTHERSAFETYHAZARDS 42 Excessive temperatures

22、 13 46 Human errors 13 O BSI 1998 Page 4 EN 60601-2-401998 Pages SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data 13 51 Protection against hazardous output . 14 SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS S

23、ECTION TEN: CONSTRUCTIONAL REQUIREMENTS Figure 101 . 15 Annexes L - References - Publications mentioned in this Standard AA (informative) - General guidance and rationale . ZA Normative references to international publications with their corresponding European publications . 16 17 19 O BSI 1998 STD-

24、BSI BS EN bObOL-Z-qU-ENGL 1198 lb24bb7 0709LOb 717 Page 5 EN 60601 -2-40: 1998 INTRODUCTION This Particular Standard 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 amendment

25、2 (1995), hereinafter referred to as the General Standard (see 1.3). The requirements are followed by specifications for the relevant tests. Following the decision taken by subcommittee 62D at the meeting in Washington in 1979, a “General guidance and rationale“ section giving some explanatory notes

26、, where appropriate, about the more important requirements is included in annex AA. Clauses or subclauses for which there are explanatory notes in annex AA are marked with an asterisk (*). It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper app

27、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. * * CI) STD-BSI BS EN bObfl3-2-YO-ENGL 3778 LbZLibb7 0707307

28、 825 Page 6 EN 60601-2-40 1998 MEDICAL ELECTRICAL EQUIPMENT - Part 2-40: Particular requirements for the safety of electromyosraphs and evoked response equipment SECTION ONE: GENERAL The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object This c

29、lause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard applies to ELECTROMYOGRAPHS as defined in 2.1 .lo1 and EVOKED RESPONSE EQUIPMENT as defined in 2.1.102, hereinafter referred to as EQUIPMENT. 1.2 Object Replacement: The object of this Particular St

30、andard is to establish particular requirements for the safety of respectively. ELECTROMYOQRAPHS and EVOKED RESPONSE EQUIPMENT as defined in 2.1.101 and 2.1.102, 1.3 Particular Standards Addition: This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment - Part 7: General re

31、quirements for safety as amended by its amendment 1 (1991) and amendment 2 (1995). For brevity, IEC 60601-1 is referred to in this Particular Standard either as the General Standard“ or as the “General Requirement(s)“. The numbering of sections, clauses and subclauses of this Particular Standard cor

32、responds to 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. Page 7 EN 60601-2-40:1998

33、“Addition“ means that the text of the 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. Subclauses or figures which are additional to t

34、hose of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. The term “this Standard“ is used to make references to the General Standard and this Particular Standard taken together. Where there is no corresponding sect

35、ion, 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 not to be applied, a statement to t

36、hat effect is given in this Particular Standard. The requirements of this Particular Standard take priority over those of the General Standard. 1.5 Collateral Standards Addition: Collateral Standards IEC 60601-1-1 as amended by its amendment 1 and IEC 60601-1-2 have been taken into consideration in

37、this Particular Standard (see 6.8.2 and clause 36). _I = E e II E - - _I * 2 Terminology and definitions 10 * This clause of the General Standard applies except as follows: Additional definitions: 2.1 .lo1 ELECTROMYOGRAPH MEDICAL ELECTRICAL EQUIPMENT for the detection and analysis of biopotentials a

38、ccompanying nerve and muscle action, either spontaneously, intentionally or evoked by electrical or other stimulation 2.1.102 EVOKED RESPONSE EQUIPMENT MEDICAL ELECTRICAL EQUIPMENT for the detection and analysis of biopotentials resulting from an evoking stimulus. The stimulus may be electrical, tac

39、tile, auditory, visual, olfactory, etc. 2.1.103 ELECTRICAL STIMULATOR parts of EQUIPMENT for the application of electric currents via electrodes in direct contact with the PATIENT, for the evoking of biopotentials or other action STD-BSI BS EN bObOL-2-4O-ENGL 1998 Lb24bb9 0709309 bT8 Page 8 EN 60601

40、-2-401998 2.1 .lo4 PULSE DURATION duration of the electrical stimulus pulse WAVEFORM at 50 % of the peak amplitude 2.1.105 WAVEFORM variations in magnitude of an electrical stimulus output (in either voltage or current) as a function Of time appearing in the APPLIED PART Of the ELECTRICAL STIMULATOR

41、 2.1.106 parts of EQUIPMENT for the application of sound pressure from a transducer (headphone, bone conductor or free-field) to the ear(s) of the PATIENT, for the evoking of biopotentials or other action AUDITORY STIMULATOR 2.1.1 07 VISUAL STIMULATOR parts of EQUIPMENT or SYSTEM for the application

42、 of electromagnetic radiation in the visible spectrum from a transducer to the eyes of the patient, for the evoking of biopotentials or other action 2.1.108 BIOPOTENTIAL INPUT PART APPLIED PART(S) Of EQUIPMENT or SYSTEM for the COlleCtiOn Of biopotentials 5 Classification This clause of the General

43、Standard applies except as follows: “5.2 According to the degree of protection against electric shock: Amendment: Delete TYPE B APPLIED PART. “5.6 According to the mode of operation: Amendment: Delete all except CONTINUOUS OPERATION. 6 Identification, marking and documents This clause of the General

44、 Standard applies except as follows: 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts j) Power input Page 9 EN 60601-2-401998 Amendment: Replace the fourth paragraph by the following: The RATED power input of mains operated EQUIPMENT shall be the maximum power input averaged over any perio

45、d of 5 s under the conditions set out in item aa) of 7.1. p) Outpuf Addition: EQUIPMENT capable of delivering electrical stimulus outputs into a load resistance of 1 O00 i2 in excess of 10 mA r.m.s. or 10 V r.m.s. averaged over any period of 5 s shall be marked near the electrode connections with th

46、e symbol No. 14 (see annex D of the General Standard). 6.7 Indicator lights and push-buttons Addition: See also 51.1 02. 6.8 ACCOMPANYING DOCUMENTS 6.8.2 Instructions for use Additional item: The instructions for use shall additionally contain the following: aa) Information on the output WAVEFORM(S)

47、, including any d.c. component, PULSE DURATIONS, pulse repetition frequencies, maximum amplitude of output voltage and/or current, and the effect of load impedance on the demanded parameters. bb) Advice on the size of electrodes to be used and the method of application for each particular type of ex

48、amination for which the ELECTRICAL STIMULATOR is intended. cc) Advice on any necessary precautions to be taken when the output contains a d.c. component. dd) Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to electrical stimulation

49、unless specialist medical opinion has first been obtained. Advice to avoid trans-thoracic stimulation, for example maintenance of anode and cathode stimulating sites in close proximity. ee) Page 10 EN 60601-2-40:1998 ft) A warning on the following potential SAFETY HAZARDS: 0 connection of a PATIENT to a h.f. surgical equipment and to an ELECTROMYOGRAPH or EVOKED RESPONSE EQUIPMENT SmUltaneOUSly may result in burns at the Site Of the ELECTRICAL STIMULATOR or BIOPOTENTIAL INPUT PART electrodes and possible damage to the ELECTRICAL STIMULATOR or biol