1、BRITISH STANDARD BS EN 60601-2-40: 1998 IEC 60601-2-40: 1998 BS5724-2.40: 1998 Medical electrical equipment Part 2-40: Particular requirements for safety Specification for electromyographs and evoked response equipment The European Standard EN 60601-2-40:1998 has the status of a British Standard ICS
2、 11.040.50BSEN60601-2-40:1998 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, waspublished under the authorityof the Standards Boardand comes into effecton 15June1998 BSI 05-1999 ISBN 0 580 29950 3 National foreword This British Standard is
3、the English language version of EN60601-2-40:1998. It is identical with IEC60601-2-40:1998. The UK participation in its preparation was entrusted to Technical Committee CH/99, Neurological electrodiagnostic, which has the responsibility to: aid enquirers to understand the text; present to the respon
4、sible 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 this committee can be obtained on req
5、uest to its secretary. From 1 January1997, all IEC publications have the number60000 added to the old number. For instance, IEC27-1 has been renumbered as IEC60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both sy
6、stems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publica
7、tions may be found in the BSI 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
8、British Standards are responsible 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 front cover, pages i and ii, theEN title page, pages 2 to11 and a back cove
9、r. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSEN60601-2-40:1998 BSI 05-1999 i Contents Page National foreword Inside
10、 front cover Foreword 2 Text of EN60601-2-40 3ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-40 April 1998 ICS 11.040.50 Descriptors: Medical electrical equipment, electromyographs, evoked response equipment, safety requirements, protection against electric shock, protection ag
11、ainst mechanical hazard, radiation protection, fire protection, environmental conditions English version Medical electrical equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC60601-2-40:1998) Appareils lectromdicaux Partie2-40: Rgles par
12、ticulires de scuritpour les lectromyographes etlesappareils potentiel voqu (CEI60601-2-40:1998) Medizinische elektrische Gerte Teil2-40: Besondere Festlegungen fr die Sicherheit von Elektromyographen und Gerten fr evozierte Potentiale (IEC60601-2-40:1998) This European Standard was approved by CENEL
13、EC on1998-04-01. CENELEC members are bound to comply 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
14、 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 any other language made by translation under the responsibility of a CENELEC member into its own language and notified
15、 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, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Sw
16、itzerland and United Kingdom. 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 1998 CENELEC All rights of exploitation in any form
17、and by any means reserved worldwide for CENELEC members. Ref. No. EN60601-2-40:1998 EEN60601-2-40:1998 BSI 05-1999 2 Foreword The text of document62D/255/FDIS, future edition1 of IEC60601-2-40, prepared by SC62D, Electromedical equipment, of IEC TC62, Electrical equipment in medical practice, was su
18、bmitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN60601-2-40 on1998-04-01. The following dates were fixed: 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 norma
19、tive and Annex AA and Annex ZB are informative. Annex ZA and Annex ZB have been added by CENELEC. Endorsement notice The text of the International Standard IEC60601-2-40:1998 was approved by CENELEC as a European Standard without any modification. Contents Page Foreword 2 Introduction 3 Section 1. G
20、eneral 1 Scope and object 3 2 Terminology and definitions 4 5 Classification 4 6 Identification, marking and documents 4 7 Power input 5 Section 2. Environmental conditions Section 3. Protection against electric shock hazards 14 Requirements related to classification 5 20 Dielectric strength 5 Secti
21、on 4. Protection against mechanical hazards Section 5. Protection against hazards from unwanted or excessive radiation 36 Electromagnetic compatibility 6 Section 6. Protection against hazards of ignitionofflammable anaesthetic mixtures Section 7. Protection against excessive temperatures and other s
22、afety hazards 42 Excessive temperatures 6 46 Human errors 6 Section 8. Accuracy of operating data and protectionagainst hazardous output 50 Accuracy of operating data 7 51 Protection against hazardous output 7 Section 9. Abnormal operation and fault conditions;environmental tests Section 10. Constru
23、ctional requirements Annex L References Publications mentioned in this Standard 9 Annex AA (informative) General guidance and rationale 9 Annex ZA (normative) Normative references tointernational publications with their corresponding European publications 11 Annex ZB (informative) Other internationa
24、l publications mentioned in this standard with the references of the relevant European publications 11 Figure 101 Layout of testing arrangements (see36.201.1.7 and36.202.2.2 d) 8 latest date by which the ENhas to be implemented at national level by publication of an identical national standard or by
25、 endorsement (dop) 1999-01-01 latest date by which the national standards conflicting with the EN haveto be withdrawn (dow) 2001-01-01EN60601-2-40:1998 BSI 05-1999 3 Introduction This Particular Standard amends and supplements IEC60601-1 (second edition, 1988): Medical electrical equipment Part1: Ge
26、neral requirements for safety, as amended by its amendment1 (1991) and amendment2 (1995), hereinafter referred to as the General Standard (see1.3). The requirements are followed by specifications for the relevant tests. Following the decision taken by subcommittee62D at the meeting in Washington in1
27、979, a “General guidance and rationale” section giving some explanatory notes, 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
28、of the reasons for these requirements will not 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 o
29、f this Standard. Section 1. 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 applies to ELECTROMYOGRAPHS as defined in2.1.
30、101 and EVOKED RESPONSE EQUIPMENT as defined in2.1.102, hereinafter referred to as EQUIPMENT. 1.2 Object Replacement: The object of this Particular Standard is to establish particular requirements for the safety of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT as defined in2.1.101 and2.1.102, respe
31、ctively. 1.3 Particular Standards Addition: This Particular Standard refers to IEC60601-1 (1988): Medical electrical equipment Part1:General requirements for safety as amendedby its amendment1 (1991) and amendment2 (1995). For brevity, IEC60601-1 is referred to in this Particular Standard either as
32、the “General Standard” or as the “General Requirement(s)”. The numbering of sections, clauses and subclauses of this Particular Standard corresponds 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 t
33、hat the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard. “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 Stand
34、ard is amended as indicated by the text of this Particular Standard. Subclauses or figures which are additional to those of the General Standard are numbered starting from101, additional annexes are lettered AA, BB,etc., and additional items aa), bb), etc. The term “this Standard” is used to make re
35、ferences to the General Standard and this Particular Standard taken 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
36、intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that 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: Collate
37、ral Standards IEC60601-1-1 as amended by its amendment1 and IEC60601-1-2 have been taken into consideration in this Particular Standard (see6.8.2 and clause36).EN60601-2-40:1998 4 BSI 05-1999 2 Terminology and definitions This clause of the General Standard applies except as follows: Additional defi
38、nitions: 2.1.101 ELECTROMYOGRAPH MEDICAL ELECTRICAL EQUIPMENT for the detection and analysis of biopotentials accompanying 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
39、detection and analysis of biopotentials resulting from an evoking stimulus. The stimulus may be electrical, tactile, 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
40、evoking of biopotentials or other action 2.1.104 PULSE DURATION duration of the electrical stimulus pulse WAVEFORM at50% 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
41、of the ELECTRICAL STIMULATOR 2.1.106 AUDITORY STIMULATOR 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 2.1.107 VISUAL STIMULATOR parts of EQUIPMENT or
42、 SYSTEM for the application 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
43、This clause of the General 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
44、 This clause of the General Standard applies except as follows: 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts j) Power input 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 per
45、iod of5 s under the conditions set out in item aa) of7.1. p) *Output Addition: EQUIPMENT capable of delivering electrical stimulus outputs into a load resistance of1 000 7 in excess of10 mA r.m.s. or10 V r.m.s. averaged over any period of5 s shall be marked near the electrode connections with the sy
46、mbol No.14 (see Annex D of the General Standard). 6.7 Indicator lights and push-buttons Addition: See also51.102. 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), incl
47、uding 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 examina
48、tion for which the ELECTRICAL STIMULATOR is intended.EN60601-2-40:1998 BSI 05-1999 5 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
49、 to electrical stimulation unless specialist medical opinion has first been obtained. ee) Advice to avoid trans-thoracic stimulation, for example maintenance of anode and cathode stimulating sites in close proximity. ff) A warning on the following potential SAFETY HAZARDS: connection of a PATIENT to a h.f. surgical equipment and to an ELECTROMYOGRAPH or EVOKED RESPONSE EQUIPMENT simultaneously may result in burns at the site of the ELECTRICAL STIMULATOR or BIOPOTENTIAL INPUT PART electrodes and possible damage to the ELECTRICAL STIMU
