1、BRITISH STANDARD BS EN 60601-2-26:2003 Medical electrical equipment Part 2-26: Particular requirements for the safety of electroencephalographs The European Standard EN 60601-2-26:2003 has the status of a British Standard ICS 11.040.55; 11.040.99 BS EN 60601-2-26:2003 This British Standard, was publ
2、ished under the authority of the Standards Policy and Strategy Committee on 15 August 2003 BSI 15 August 2003 ISBN 0 580 42447 2 National foreword This British Standard is the official English language version of EN 60601-2-26:2003. It is identical with IEC 60601-2-26:2002. It supersedes BS EN 60601
3、-2-26:1995 which is withdrawn. 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 this subcommitte
4、e 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 by using the “Sear
5、ch” 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 immunity from legal ob
6、ligations. aid enquirers to understand the text; 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. Summar
7、y of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 20, an inside back cover 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 Comment
8、sEUROPEAN STANDARD EN 60601-2-26 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
9、CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-26:2003 E ICS 11.040.55; 11.040.99 Supersedes EN 60601-2-26:1994English version Medical electrical equipment Part 2-26: Particular requirements for the safety of electroencep
10、halographs (IEC 60601-2-26:2002) Appareils lectromdicaux Partie 2-26: Rgles particulires de scurit pour les lectroencphalographes (CEI 60601-2-26:2002) Medizinische elektrische Gerte Teil 2-26: Besondere Festlegungen fr die Sicherheit von Elektroenzephalographen (IEC 60601-2-26:2002) This European S
11、tandard was approved by CENELEC on 2003-03-01. 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 conc
12、erning 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 any other language made by translation under the responsibility of a CENELEC member into
13、 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, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg
14、, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EN 60601-2-26:2003 - 2 - Foreword The text of document 62D/463/FDIS, future edition 2 of IEC 60601-2-26, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practi
15、ce, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-26 on 2003-03-01. This European Standard supersedes EN 60601-2-26:1994. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical nati
16、onal standard or by endorsement (dop) 2004-02-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2006-03-01 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this sta
17、ndard, annex ZA is normative and annex AA is informative. Annex ZA has been added by CENELEC. In this particular standard, the following print types are used: requirements, compliance with which can be tested, and definitions: roman type; notes, explanations, advice, introductions, general statement
18、s, exceptions and references: smaller roman type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR IN THIS PARTICULAR STANDARD: SMALL CAPITALS. _ Endorsement notice The text of the International Standard IEC 60601-2-26:2002 was approved by CENELEC as a European
19、Standard without any modification. _ Page2 EN60601226:2003 3 CONTENTS INTRODUCTION.5 SECTION ONE GENERAL *1 Scope and object.6 2 Terminology and definitions7 *4 General requirements for tests 8 5 Classification8 *6 Identification, marking and documents.8 SECTION TWO ENVIRONMENTAL CONDITIONS SECTION
20、THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 13 General9 14 Requirements related to classification 10 *17 Separation.10 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS11 *20 Dielectric strength.11 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZ
21、ARDS 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 *42 Excessive temperatures.13 SECTION EIGHT ACCURACY OF
22、OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of OPERATING data .13 Page3 EN60601226:2003 4 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly 13 Appendix L References - Publication
23、s mentioned in this standard16 Annex AA (informative) General guidance and rationale17 Index of defined terms 19 *Figure 101 Application of the test voltage to test the delivered defibrillator energy (see 17h).14 Figure 102 Set-up for test of radiated and conducted emissions (see 36.201.1 b) 1).15 A
24、nnex ZA (normative) Normative references to international publications with their corresponding European publications 20 Page4 EN60601226:2003 5 INTRODUCTION This Particular Standard concerns the safety of electroencephalographs. It amends and supplements IEC 60601-1 (second edition 1988): Medical e
25、lectrical equipment Part 1: General requirements for safety, including its Amendment 1 (1991) and Amendment 2 (1995), hereinafter referred to as 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
26、knowledge 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, Annex AA does not form part of the requir
27、ements of this standard. An asterisk (*) by a clause or subclause number indicates that explanatory notes are given in Annex AA of this Particular Standard. Page5 EN60601226:2003 6 MEDICAL ELECTRICAL EQUIPMENT Part 2-26: Particular requirements for the safety of electroencephalographs SECTION ONE GE
28、NERAL The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object *1.1 Scope Addition: This Particular Standard specifies the particular safety requirements for ELECTRO- ENCEPHALOGRAPHS as defined in 2.2.103 and also referred to as EQUIPMENT. The sp
29、ecial requirements for other equipment also used in electroencephalography are not covered by this standard, for example: cerebral function monitors; phono-photic stimulators; electroencephalographic telemetry; EEG data storage and retrieval; EQUIPMENT particularly intended for monitoring during ele
30、ctro-convulsive therapy; ambulatory electroencephalographic recorders. 1.2 Object Replacement: The object of this Particular Standard is to specify particular requirements for the safety of ELECTROENCEPHALOGRAPHS. 1.3 Particular Standards Addition: This Particular Standard amends and supplements IEC
31、 60601-1 (1988): Medical electrical equipment Part 1: General requirements 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)”, and IEC 60601-1-
32、2 and IEC 60601-1-4 as the “Collateral Standards”. The numbering of sections, clauses and subclauses of this Particular Standard corresponds with 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 th
33、e clause or subclause of the General Standard is replaced completely by the text of this Particular Standard. Page6 EN60601226:2003 7 “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 o
34、f the General Standard 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 from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. The term “this Standar
35、d” is used to make reference 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 modifi
36、cation; where it is 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 and Collateral Standard
37、s mentioned above. 1.7 Collateral Standards IEC 60601-1-2:2001, Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests IEC 60601-1-4:1996, Medical electrical equipment Part 1: General requirements for safety 4.
38、 Collateral Standard: Programmable electrical medical systems 2 Terminology and definitions 2.2 EQUIPMENT types (classification) Addition: 2.2.101 CHANNEL complete system for the amplification and conditioning of potential differences between a pair or combination of ELECTRODES 2.2.102 ELECTROENCEPH
39、ALOGRAM (EEG) display or record of the variation with time of voltages taken from electrodes on the scalp, whose positions are specified IEV 891-04-23, modified 2.2.103 ELECTROENCEPHALOGRAPH (EQUIPMENT) device to produce an ELECTROENCEPHALOGRAM IEV 891-04-24 2.2.104 EQUIPMENT ELECTRODE conductor app
40、lied over, or inserted into, a region of the scalp or brain to detect electrical activity of the brain in combination with another ELECTRODE or ELECTRODES Page7 EN60601226:2003 8 2.2.105 NEUTRAL ELECTRODE ELECTRODE used as a common mode reference for differential amplifiers and/or interference suppr
41、ession which is not involved in an EQUIPMENT ELECTRODE combination 4 General requirements for tests *4.11 Sequence Addition : If applicable, tests called for in 17h) of the General Standard shall be carried out prior to the LEAKAGE CURRENT and dielectric strength tests of the General Standard. 5 Cla
42、ssification 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 but CONTINUOUS OPERATION. 6 Identification, marking and documents 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT pa
43、rts Addition: *aa) EQUIPMENT not protected against the effects of defibrillation Parts of an EQUIPMENT (for example, PATIENT CABLES or sensors) specified as not being protected against the effects of defibrillation shall be marked with the symbol 14 of table DI in Appendix D of the General Standard.
44、 *6.8.2 Instructions for use Addition: aa) The instructions for use shall also include: 1) The procedures necessary for safe operation. 2) The type of electrical installation to which the EQUIPMENT may be safely connected, including the connection of any POTENTIAL EQUALIZATION CONDUCTOR. 3) That con
45、ductive parts of ELECTRODES and their connectors, including the NEUTRAL ELECTRODE, should not contact other conductive parts including earth. 4) If the ELECTROENCEPHALOGRAPH is provided with means to prevent burning of the PATIENT when used with high frequency (HF) surgical equipment, this shall be
46、drawn to the attention of the OPERATOR. If no such means are incorporated, advice shall be given regarding the location of the ELECTRODES to reduce the hazard of burns in the event of a defect in the HF surgical neutral electrode connection. Page8 EN60601226:2003 9 5) The possible hazard caused by t
47、he summation of LEAKAGE CURRENTS when several EQUIPMENTS are interconnected. 6) The need for regular testing of the ELECTROENCEPHALOGRAPH and its accessories. 7) Where relevant, a statement that the ELECTROENCEPHALOGRAPH is protected against the effects of a cardiac defibrillator discharge. In addit
48、ion, information shall be provided on the specification (and type number, if necessary) of any accessory where this incorporates defibrillation protection (see 17h of this Particular Standard). 8) Where relevant, the precautions to be taken when a defibrillator is used on a PATIENT connected to an E
49、LECTROENCEPHALOGRAPH. 9) Where relevant, subsequent operation of the EQUIPMENT after a cardiac defibrillator discharge shall be disclosed. 10) The intended function of the EQUIPMENT. 11) The intended environment of use. 12) Any safety hazard due to simultaneous use of other PATIENT-connected EQUIPMENT, for example, a cardiac pacemaker or other electrical
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