Bsi bs en 60601 2 26 2015

BS EN 60601-2-26:2015 BSI Standards Publication Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs BRITISH STANDARD BS EN 60601-2-26:2015 National foreword This British Standard is the UK implementation of EN 60601-2-26:2015 It is identical to IEC 60601-2-26:2012 It supersedes BS EN 60601-2-26:2003, which will be withdrawn on 14 April 2018 The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment A list of organizations represented on this committee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application © The British Standards Institution 2015 Published by BSI Standards Limited 2015 ISBN 978 580 60664 ICS 11.040.55; 11.040.99 Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2015 Amendments/corrigenda issued since publication Date Text affected BS EN 60601-2-26:2015 EUROPEAN STANDARD EN 60601-2-26 NORME EUROPÉENNE EUROPÄISCHE NORM May 2015 ICS 11.040.55; 11.040.99 Supersedes EN 60601-2-26:2003 English Version Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (IEC 60601-2-26:2012) Appareils électromédicaux - Partie 2-26: Exigences particulières pour la sécurité de base et les performances essentielles des électroencéphalographes (IEC 60601-2-26:2012) Medizinische elektrische Geräte - Teil 2-26: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen (IEC 60601-2-26:2012) This European Standard was approved by CENELEC on 2015-04-14 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 may be obtained on application to the CEN-CENELEC Management Centre 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 CEN-CENELEC Management Centre has the same status as the official versions CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members Ref No EN 60601-2-26:2015 E BS EN 60601-2-26:2015 EN 60601-2-26:2015 Foreword The text of document 62D/990/FDIS, future edition of IEC 60601-2-26, prepared by SC 62D "Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-26:2015 The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60601-2-26:2003 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s) For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document Endorsement notice The text of the International Standard IEC 60601-2-26:2012 was approved by CENELEC as a European Standard without any modification BS EN 60601-2-26:2015 EN 60601-2-26:2015 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies NOTE When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies NOTE Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year EN 60601-1-2 2007 + corrigendum Mar 2010 In Annex ZA of EN 60601-1:2006 replace IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 - - Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility - Requirements and tests Add to Annex ZA of EN 60601-1:2006 the following new references: IEC 60601-1 2005 - - - - IEC 60601-2-27 2011 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment EN 60601-1 2006 + corrigendum Mar 2010 + A12 2014 EN 60601-2-27 2014 BS EN 60601-2-26:2015 EN 60601-2-26:2015 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard –2– BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 CONTENTS FOREWORD INTRODUCTION 201.1 Scope, object and related standards 201.2 Normative references 201.3 Terms and definitions 201.4 General requirements 201.5 General requirements for testing of ME EQUIPMENT 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 10 201.7 M E EQUIPMENT identification, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 17 201.10 Protection against unwanted and excessive radiation HAZARDS 17 201.11 Protection against excessive temperatures and other HAZARDS 17 201.12 Accuracy of controls and instruments and protection against hazardous outputs 18 201.13 H AZARDOUS SITUATIONS and fault conditions 23 201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) 23 201.15 Construction of ME EQUIPMENT 23 201.16 M E SYSTEMS 23 201.17 E LECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS 23 202 E LECTROMAGNETIC COMPATIBILITY – Requirements and tests 23 Annexes 26 Annex AA (informative) Particular guidance and rationale 27 Index of defined terms used in this particular standard 29 Figure 201.101 – Test of protection against the effects of defibrillation (common mode) 14 Figure 201.102 – Test of protection against the effects of defibrillation (differential mode) 15 Figure 201.103 – Application of the test voltage between LEAD WIRES to test the energy delivered by the defibrillator 16 Figure 201.104 – General test circuit 20 Figure 201.105 – Test circuit for COMMON MODE REJECTION 22 Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated immunity test 24 Figure 202.102 – Set-up for radiated immunity test according to 202.6.2.3.2 25 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements 10 BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 –3– INTERNATIONAL ELECTROTECHNICAL COMMISSION MEDICAL ELECTRICAL EQUIPMENT – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees) The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”) Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work International, governmental and nongovernmental organizations liaising with the IEC also participate in this preparation IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter 5) IEC itself does not provide any attestation of conformity Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity IEC is not responsible for any services carried out by independent certification bodies 6) All users should ensure that they have the latest edition of this publication 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications 8) Attention is drawn to the Normative references cited in this publication Use of the referenced publications is indispensable for the correct application of this publication 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights IEC shall not be held responsible for identifying any or all such patent rights International standard IEC 60601-2-26 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice This third edition cancels and replaces the second edition of IEC 60601-2-26 published in 2002 This edition constitutes a technical revision to the new structure of the third edition (2005) of IEC 60601-1 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/990/FDIS 62D/1012/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table –4– BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 This publication has been drafted in accordance with the ISO/IEC Directives, Part In this standard, the following print types are used: – Requirements and definitions: roman type – Test specifications: italic type – Informative material appearing outside of tables, such as notes, examples and references: in smaller type Normative text of tables is also in a smaller type – T ERMS DEFINED IN C LAUSE OF THE GENERAL STANDARD , IN THIS PARTICULAR STANDARD OR AS NOTED : SMALL CAPITALS In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g Clause includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7) References to clauses within this standard are preceded by the term “Clause” followed by the clause number References to subclauses within this collateral standard are by number only In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part For the purposes of this standard, the auxiliary verb: – “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; – “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; – “may” is used to describe a permissible way to achieve compliance with a requirement or test An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific publication At this date, the publication will be • • • • reconfirmed, withdrawn, replaced by a revised edition, or amended BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 –5– INTRODUCTION This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), hereinafter referred to as the general standard The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes The requirements of this particular standard take priority over those of the general standard A “General guidance and rationale” for the more important requirements of this particular standard is included in Annex AA It is considered that 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 requirements of this standard BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 201.9 Protection ME SYSTEMS – 17 – against MECHANICAL HAZARDS of ME EQUIPMENT and Clause of the general standard applies 201.10 Protection against unwanted and excessive radiation HAZARDS Clause 10 of the general standard applies 201.11 Protection against excessive temperatures and other HAZARDS Clause 11 of the general standard applies, except as follows: *Spillage on ME EQUIPMENT and ME SYSTEMS 201.11.6.3 Replacement: P ORTABLE / TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT separable while remaining functioning shall be so constructed so that, in the event of spillage of liquids (accidental wetting), no HAZARDOUS SITUATION results from the ingress of liquids The ME EQUIPMENT shall meet the dielectric strength requirements specified in 8.8.3 of the general standard and shall comply with the requirements of this particular standard Compliance is checked by the following test: Place the PORTABLE / TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT in the least favourable position of NORMAL USE Subject the ME EQUIPMENT for 30 s to an artificial rainfall of mm/min falling vertically from a height of 0,5 m above the top of the ME EQUIPMENT A test apparatus is shown in Figure of IEC 60529 An intercepting device may be used to determine the duration of the test Immediately after 30 s exposure, remove any visible moisture on the ENCLOSURE Immediately after the above test, verify (by inspection) that any water that entered the ME EQUIPMENT cannot adversely affect the BASIC SAFETY of the ME EQUIPMENT Verify that the ME EQUIPMENT meets the relevant dielectric strength test (8.8.3 of the general standard) and does not result in a HAZARDOUS SITUATION After this test, verify that the ME EQUIPMENT complies with the requirements of this particular standard 201.11.8 *Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT Addition: If the SUPPLY MAINS to the ME EQUIPMENT is interrupted for less than 30 s, no change of OPERATOR settings shall occur, including the mode of operation, or all stored PATIENT data shall remain available NOTE The ME EQUIPMENT does not have to remain in operation during the interruption of the SUPPLY MAINS BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 – 18 – Compliance is checked by observing the ME EQUIPMENT operating mode, OPERATOR settings, and stored data and interrupting the SUPPLY MAINS for a period of between 25 s and 30 s by disconnecting the POWER SUPPLY CORD If the SUPPLY MAINS is interrupted for more than 30 s, the subsequent operation shall be one of the following: – reversion to the MANUFACTURER ’ S default settings; – reversion to previous RESPONSIBLE ORGANIZATION ’ S default settings or; – reversion to the last settings used NOTE Means may be provided to the OPERATOR to select one or more than one of the above options Compliance shall be checked by inspection If the ME EQUIPMENT contains an INTERNAL ELECTRICAL POWER SOURCE and the SUPPLY MAINS is interrupted, the ME EQUIPMENT shall continue normal operation by switching automatically to operating from its INTERNAL ELECTRICAL POWER SOURCE , and the mode of operation, all OPERATOR settings and stored data shall not be changed Power-saving measures may be taken provided the ME EQUIPMENT continues to conform to this particular standard M E E QUIPMENT shall visually indicate the operation from its INTERNAL ELECTRICAL POWER SOURCE Compliance is checked by interrupting the SUPPLY MAINS and observing that OPERATOR settings and stored data are not changed, that normal operation continues, and that a visual ME EQUIPMENT is operating from its indication is displayed that the INTERNAL ELECTRICAL POWER SOURCE The ‘on-off’ switch shall remain in the ‘on’ position 201.12 Accuracy of controls hazardous outputs and instruments and protection against Clause 12 of the general standard applies, except as follows: 201.12.1 Accuracy of controls and instruments Addition: 201.12.1.101 201.12.1.101.1 E SSENTIAL PERFORMANCE requirements Accuracy of signal reproduction Input signals in the range of ±0,5 mV, varying at a rate to 12 mV/s, shall be reproduced on the output with an error of ≤ ±20 % of the nominal value of the output or ±10 µV, whichever is greater Compliance is checked using the test circuit of Figure 201.104 Close switches S, and S2 Connect the signal generator to apply a triangular wave of Hz to any LEAD WIRE of a CHANNEL with all other LEAD WIRES connected to the reference LEAD WIRE Adjust the GAIN of the ME EQUIPMENT to 0,1 mm/ µ V Adjust the signal generator to produce a peak-to-valley output on a display device that is 10 % of the full scale peak-to-valley output Increase the output of the signal generator by factors of 2, and 10 The displayed output shall be linear within ± 20 % of the full scale output Repeat for each LEAD WIRE of the available CHANNELS until all combinations of LEAD WIRES have been tested BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 – 19 – Connect the signal generator to any LEAD WIRE of a CHANNEL with all other LEAD WIRES connected to the reference LEAD WIRE Adjust the signal generator to apply a mV peak-tovalley input Hz triangular signal at a GAIN of 0,01 mm/ µV Verify that the output display is completely visible and the peak-to-valley amplitude is within (8 to 12) mm Repeat for each LEAD WIRE of the available CHANNELS until all combinations of LEAD WIRES have been tested NOTE The defined term GAIN is used for test purposes and does not mean that a scale on a display or printout should be labelled in mm/µV 201.12.1.101.2 *Input dynamic range and differential offset voltage With a d.c offset voltage in the range of ±300 mV and differential input signal voltages of ±0,5 mV that vary at rates up to 12 mV/s, when applied to any LEAD WIRE , the time-varying output signal amplitude shall not change by more than ±10 % over the specified range of d.c offset Compliance is checked using the test circuit of Figure 201.104 Close switches S and S2 Adjust the signal generator to produce a Hz triangular signal of mV peak-to-valley to any LEAD WIRE of a CHANNEL and all other LEAD WIRES connected to the reference LEAD WIRE Adjust the GAIN to occupy about 80% of the display’s full scale peak-to valley output Open switch S2 to apply a +300 mV d.c offset voltage Changing switch S3 to apply a -300 mV d.c offset voltage Verify that the output signal amplitude is within ± 10% of the specified offset voltage range Repeat for each LEAD WIRE until all CHANNELS have been tested BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 – 20 – S3 ± 300 mV S1 A P1 P4 S2 R1 100 kΩ 0,1 % S R2 CHANNEL CHANNEL CHANNEL CHANNEL n EUT 100 Ω 0,1 % P3 P2 47 nF P5 10kΩ 51 kΩ LEAD WIRE (reference) IEC 1013/12 Components ① PATIENT CABLE ② Signal generator; output impedance kΩ and linearity ± % ③ d.c offset voltage source; the voltage divider consisting of resistors is used to adjust the d.c output voltage to 300 mV ④ Shield S1 Switch, shorts signal source impedance S2 Switch, shorts unbalance caused by skin impedance S3 Switch, changes polarity of d.c offset voltage source S4 Switch, shorts the d.c offset voltage source S Switch; disconnects the signal generator Each LEAD has in series 10 kΩ to simulate the skin impedance The shield around the entire test configuration minimizes induction from mains voltage The figure illustrates the general test circuit for: − − − − 201.12.1.101.1 201.12.1.101.2 201.12.1.101.3 201.12.1.101.4 (accuracy of signal reproduction); (input dynamic range and differential offset voltage); (input noise); (frequency response); Figure 201.104 – General test circuit 201.12.1.101.3 Input noise The signal noise caused by the EEG amplifier and PATIENT CABLE shall not exceed µV peakto-valley referred to the input (RTI) BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 – 21 – Compliance is checked using the test circuit of Figure 201.104.Any mains frequency notch filter, if provided, is to be turned on during this test Connect all LEAD WIRES of the PATIENT CABLE together When the PATIENT CABLE is motionless, the NOISE referred to the input shall not exceed µV peak-to-valley referred to the input 201.12.1.101.4 Frequency response M E EQUIPMENT shall meet the requirement for a frequency response (bandwidth) of at least 0,5 Hz to 50 Hz when tested with sinusoidal input signals The output at 0,5 Hz and 50 Hz shall be within 71 % to 110 % of the output obtained with a Hz sine wave input signal Compliance is checked using the test circuit of Figure 201.104 The mains frequency notch filter, if provided, and filter settings are to be off for this test Close switches S and S2 Adjust the GAIN of the ME EQUIPMENT to 0,05 mm/ µV Use the signal generator to apply a Hz, 200 µV peak-to-valley sine wave signal between any LEAD WIRE of a CHANNEL with all other LEAD WIRES connected to the reference LEAD WIRE Verify that at 0,5 Hz and 50 Hz the output signal amplitude remains within the range of 71 % to 110 % compared to the frequency of Hz 201.12.1.101.5 *Common mode rejection A V r.m.s signal at mains frequency (50 Hz/60 Hz) with 200 pF source capacitance, connected between earth and all LEAD WIRES connected together shall not produce an output signal greater than 10 mm peak-to-valley at an adjusted GAIN of 0,1 mm/µV over a 60 s period In series with each ELECTRODE shall be a 51 kΩ resistor in parallel with a 47 nF capacitor The PATIENT CABLE specified by the MANUFACTURER shall be used Compliance is checked using the test circuit of Figure 201.105 with any mains frequency notch filter (if provided) turned off a) Adjust C t to produce V r.m.s at mains frequency at point B, while no PATIENT CABLE is attached (S0 open) The common mode voltage applied to the ME EQUIPMENT is then V rms b) Close switches S0, S DC and S2 through S n and open S1 Measure the output amplitude at GAIN of 0,1 mm/ µ V over a 60 s period Then open S2 and close all other switches Repeat the amplitude measurement Continue until the measurement has been made with all LEAD WIRES c) Repeat the test with a +300 mV d.c and –300 mV d.c offset voltage in series with the imbalance impedance, by opening S DC and testing with the switch S P in each of its two positions The measured output amplitude shall not be greater than 10 mm peak-to-valley BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 – 22 – SP ± 300 mV S1 C1 100 pF B S0 A R C S2 R LEAD WIRE SDC B CHANNEL LEAD WIRE EUT C S3 R G LEAD WIRE C CHANNEL Ct CHANNEL n Sn R LEAD WIRE (reference) C Cx (stray) IEC 1014/12 Components ① Signal generator V rms mains frequency ② P ATIENT CABLE ③ DC offset source ④ Inner shield ⑤ B S1Sn C R Outer shield Common mode point Switches; invoke unbalance circuit consisting of C and R 47 nF 51 kΩ C and C t simulate the PATIENT ’ S capacitance to ground The inner shield is used to reduce the pickup of unwanted extraneous signals and to eliminate the unbalance to ground Since the capacitance C x between the inner and external shields influences both the source capacitance and the common mode voltage, this capacitance is increased by trimmer capacity to 100 pF, equal to the generator capacitor C The generator output is increased to V rms , thus providing V rms at the common mode point B with a source impedance equivalent to 200 pF when the PATIENT CABLE is not connected to the test circuit Figure 201.105 – Test circuit for COMMON MODE REJECTION (see 201.12.1.101.5) BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 201.13 – 23 – H AZARDOUS SITUATIONS and fault conditions Clause 13 of the general standard applies 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) Clause 14 of the general standard applies 201.15 Construction of ME EQUIPMENT Clause 15 of the general standard applies 201.16 M E SYSTEMS Clause 16 of the general standard applies 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS Clause 17 of the general standard applies, except as follows: Addition: Clause 202 of this particular standard applies 202 ELECTROMAGNETIC COMPATIBILITY – Requirements and tests IEC 60601-1-2:2007 applies except as follows: Requirements applicable to ME EQUIPMENT and ME SYSTEMS other than those specified for use only in a shielded location 202.5.2.2.2 Addition: E LECTROENCENPHALOGRAPHS and their ACCESSORIES shall not be considered as LIFE SUPPORTING ME EQUIPMENT 202.6 E LECTROMAGNETIC COMPATIBILITY 202.6.1 E MISSIONS 202.6.1.1.2 a) Tests P ATIENT CABLES Replacement: M E EQUIPMENT shall be tested with the PATIENT CABLE / S as specified by the MANUFACTURER with all SIP / SOP cables connected to the ME EQUIPMENT (see Figure 202.101); the distances of SIP / SOP cables between the open end and floor (ground plane) shall be ≥ 40 cm If the MANUFACTURER specifies PATIENT CABLES with different length only one representative sample of each length has to be tested The RC-network (C p , R p ) and the metal plate (7) of Figure 202.101 are not used during radiated emissions testing BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 – 24 – Dimensions in m 0,5 >1 0,3 EUT 0,05 0,3 CP RP ≥ 0,4 IEC 1015/12 Components ① P OW ER SUPPLY CORD ② SIP/SOP cable ③ Table made of insulating material ④ M E EQUIPMENT under test ⑤ PATIENT CABLE ⑥ Load simulating the PATIENT (51 kΩ in parallel with 47 nF) ⑦ Metal plate CP 220 pF RP 510 Ω and LEAD W IRES C P in series with R P simulates the body of the PATIENT Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated immunity test (see 202.6.1.1.2 a) and 202.6.2.1.10) 202.6.2 I MMUNITY E LECTROSTATIC DISCHARGE ( ESD ) 202.6.2.2 202.6.2.2.1 Requirements Addition: M E EQUIPMENT ME EQUIPMENT any OPERATOR 202.6.2.3 202.6.2.3.1 may show temporary DEGRADATION during discharges Within 30 s the shall resume normal operation in the previous operating mode, without loss of settings or stored data, and shall continue to perform its intended function Radiated RF electromagnetic fields Requirements Addition to item a): I MMUNITY TEST LEVEL of V/m applies BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 202.6.2.3.2 – 25 – Tests Addition: The test setup for radiated RF electromagnetic fields is shown in Figure 202.102: Dimensions in m >1 EUT 0,3 0,05 ≥ 0,4 IEC 1016/12 Components ① P OW ER SUPPLY CORD ② SIP/SOP cable ③ Table made of insulating material ④ M E EQUIPMENT under test ⑤ PATIENT CABLE ⑥ Head box with LEAD W IRES ; input terminals short-circuited with LEAD W IRES or head box with LEAD W IRES ; input terminals short-circuited Figure 202.102 – Set-up for radiated immunity test according to 202.6.2.3.2 Addition: aa) Any SIGNAL INPUT / OUTPUT PART cable and POWER SUPPLY CORD are arranged generally as in Figure 202.102 Maintain distances of ≥ 40 cm between SIP / SOP cables and the floor (ground plane) 202.6.2.4 202.6.2.4.1 Electrical fast transients and bursts Requirements Addition: When exposed to electrical fast transients and bursts, via the POWER SUPPLY CORD , the ME EQUIPMENT shall continue to display the EEG waveform – 26 – BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 Testing of PATIENT CABLES and interconnecting cables specified to be more than m in length may show temporary DEGRADATION during exposure of fast transients and bursts Within 10 s the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of any OPERATOR settings or stored data, and shall continue to display the EEG waveform 202.6.2.4.2 Tests Addition: aa) M E EQUIPMENT shall be located (0,8 ± 0,08) m above the reference ground plane bb) The power cord provided with the ME EQUIPMENT shall be used to connect ME EQUIPMENT to the output of the EFT / B -generator 202.6.2.6 202.6.2.6.1 Conducted disturbances, induced by RF fields Requirements Addition: aa) When exposed to a conducted radio frequency voltage, via the POWER SUPPLY CORD , the shall continue to perform its intended function as described in this particular standard ME EQUIPMENT bb) *P ATIENT CABLES are exempt from this requirement 202.6.2.6.2 Tests Addition: aa) Subclause 6.2.6.2, items c) and e) of IEC 60601-1-2:2007 not apply Annexes The annexes of the general standard apply BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 – 27 – Annex AA (informative) Particular guidance and rationale AA.1 Use with defibrillator It is possible, but not likely, that a defibrillator will be used at the same time as an ELECTROENCEPHALOGRAPH This standard does not require defibrillator protection, but instead, allows the MANUFACTURER to provide such protection against the effect of defibrillation voltages in their ME EQUIPMENT AA.2 Rationale for defibrillator test voltages Only in special cases where the ELECTRODES are known with certainty to be placed either almost exactly between the defibrillator paddles (such as oesophageal ELECTRODES ), or effectively electrically between them but at a remote point on the PATIENT (such as might appear to be the case with ELECTRODES ), can it be safely assumed that the voltage applied to the ELECTRODE will be less than the voltage of the defibrillator In such cases, a safe requirement for the ELECTRODES and the ME EQUIPMENT to which they are connected is that they need to be able to withstand somewhat over half the no-load voltage of the defibrillator Since ELECTRODES on a PATIENT ’ S head and neck should not be midway between the defibrillator paddles, we can assume they will be exposed to a considerable but unquantifiable portion of the defibrillator voltage The large number of ELECTRODES used in EEG recordings makes it possible for one or more ELECTRODES to detach and accidentally contact the thorax of the PATIENT , exposing that ELECTRODE to a large defibrillation voltage as well AA.3 Guidance and rationale for particular clauses Subclause 201.1.1 – Scope This particular standard applies to ELECTROENCEPHALOGRAPHS that acquire and display raw EEG waveforms This particular standard does not apply to any additional data processing of EEG Subclause 201.5.8 – Sequence of tests When applicable, tests of 8.5.5 are performed first in order that the tests of LEAKAGE CURRENT and dielectric strength may show any degradation in the protective means Subclause 201.7.2.1 – Minimum requirements for marking on ME EQUIPMENT and on interchangeable parts This is to avoid misuse of PATIENT CABLES not protected against defibrillator shock and not specified by the MANUFACTURER as defibrillator-proof – 28 – BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 Subclause 201.7.9.2.101 f) – Additional instructions for use Both frequent checks by the OPERATOR on, say, a daily basis and more comprehensive technical checks less frequently are covered by this requirement in order to detect mechanical damage and damage to cables etc Subclause 201.7.9.2.101 l) – Additional instructions for use It is recognized that EEG signals are of very low amplitude, and it is likely there may be some remaining unavoidable electromagnetic interference This may be acceptable based on RISK ANALYSIS and proper disclosure in the instructions for use Subclause 201.11.6.5 – Spillage on ME EQUIPMENT and ME SYSTEMS Small-sized ME EQUIPMENT or smaller parts of ME EQUIPMENT may be mounted on IV poles or used close to the PATIENT Such use close to the PATIENT makes it likely that the ME EQUIPMENT may accidentally get wet during NORMAL USE After being wetted in NORMAL USE , the ME EQUIPMENT needs to continue to provide BASIC SAFETY and ESSENTIAL PERFORMANCE to continue monitoring the PATIENT Subclause 201.11.8 – Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT Interruptions of the SUPPLY MAINS for less than 30 s are mainly caused by switching to an emergency power supply Such power interruptions are considered NORMAL USE and consequently should not result in HAZARDS to the PATIENT When the power returns, it is expected that the ME EQUIPMENT resumes the same mode of operation, and restores all OPERATOR settings and PATIENT data that were in use before the SUPPLY MAINS was interrupted Examples of typical stored data that may impact PATIENT safety are operating mode and trend data Subclause 201.12.1.101.2 – Input dynamic range and differential offset voltage M E EQUIPMENT needs to function properly in the presence of skin-to-electrode voltages that are known to be present Subclause 201.12.1.101.5 – Common mode rejection It is necessary to be able to reject to some degree the mains frequency voltages that are capacitively coupled to the PATIENT The source capacitance of 200 pF, which is achieved in the test, simulates the impedance of the PATIENT to earth Subclause 202.6.2.6.1 bb) – Requirements Due to the sensitivity of this type of ME EQUIPMENT it is not reasonable to expect the ME EQUIPMENT will be used in an environment where interference of such level will be induced BS EN 60601-2-26:2015 60601-2-26 © IEC:2012 – 29 – Index of defined terms used in this particular standard ACCESSORY IEC ACCOMPANYING DOCUMENT 60601-1:2005, 3.3 IEC 60601-1:2005, 3.4 A PPLIED PART IEC 60601-1:2005, 3.8 C HANNEL 201.3.201 C LASS II IEC 60601-1:2005, 3.14 C ONTINUOUS OPERATION IEC 60601-1:2005, 3.18 D EFIBRILLATION - PROOF APPLIED PART IEC 60601-1:2005, 3.20 D EGRADATION IEC 60601-1-2:2007, 3.2 E LECTROENCEPHALOGRAM ( EEG ) 201.3.202 E LECTROENCEPHALOGRAPH ( ME EQUIPMENT ) 201.3.63 ELECTRODE 201.3.203 E LECTROMAGNETIC COMPATIBILITY IEC 60601-1-2:2007, 3.4 E MISSION IEC 60601-1-2:2007, 3.6 E NCLOSURE IEC 60601-1:2005, 3.26 E SSENTIAL PERFORMANCE IEC 60601-1:2005, 3.27 G AIN 201.3.204 H AZARDOUS SITUATION IEC 60601-1:2005, 3.40 I NTENDED USE / INTENDED PURPOSE IEC 60601-1:2005, 3.44 I NTERNAL ELECTRICAL POWER SOURCE IEC 60601-1:2005, 3.45 L EAKAGE CURRENT IEC 60601-1:2005, 3.47 L EAD 201.3.205 L EAD WIRE ( S ) 201.3.206 L IFE - SUPPORTING ME EQUIPMENT IEC 60601-1-2:2007, 3.18 M ANUFACTURER IEC 60601-1:2005, 3.55 M EDICAL ELECTRICAL EQUIPMENT IEC 60601-1:2005, 3.63 M EDICAL ELECTRICAL SYSTEM IEC 60601-1:2005, 3.64 N EUTRAL ELECTRODE 201.3.207 N ORMAL USE IEC 60601-1:2005, 3.71 O PERATOR IEC 60601-1:2005, 3.73 P ATIENT IEC 60601-1:2005, 3.76 P ATIENT AUXILIARY CURRENT IEC 60601-1:2005, 3.77 P ATIENT CABLE 201.3.208 P OTENTIAL EQUALIZATION CONDUCTOR IEC 60601-1:2005, 3.86 P OWER SUPPLY CORD IEC 60601-1:2005, 3.87 S UPPLY MAINS IEC 60601-1:2005, 3.120 T YPE BF APPLIED PART IEC 60601-1:2005, 3.133 T YPE CF APPLIED PART IEC 60601-1:2005,3.134 _ This page deliberately left blank NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards Institution (BSI) BSI is the national body responsible for preparing British Standards and other standards-related publications, information and services BSI is incorporated by Royal Charter British Standards and other standardization products are published by BSI Standards Limited About us Revisions We bring together business, industry, government, consumers, innovators and others to shape their combined experience and expertise into standards -based solutions Our British Standards and other publications are updated by amendment or revision The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process Organizations of all sizes and across all sectors choose standards to help them achieve their goals Information on standards We can provide you with the knowledge that your organization needs to succeed Find out more about British Standards by visiting our website at bsigroup.com/standards or contacting our Customer Services team or Knowledge Centre Buying standards You can buy and download PDF versions of BSI publications, including British and adopted European and international standards, through our website at bsigroup.com/shop, where hard copies can also be purchased If you need international and foreign standards from other Standards Development Organizations, hard copies can be ordered from our Customer Services team Subscriptions Our range of subscription services are designed to make using standards easier for you For further information on our subscription products go to bsigroup.com/subscriptions With British Standards Online (BSOL) you’ll have instant access to over 55,000 British and adopted European and international standards from your desktop It’s available 24/7 and is refreshed daily so you’ll always be up to date You can keep in touch with standards developments and receive substantial discounts on the purchase price of standards, both in single copy and subscription format, by becoming a BSI Subscribing Member PLUS is an updating service exclusive to BSI Subscribing Members You will automatically receive the latest hard copy of your standards when they’re revised or replaced To find out more about becoming a BSI Subscribing Member and the benefits of membership, please visit bsigroup.com/shop With a Multi-User Network Licence (MUNL) you are able to host standards publications on your intranet Licences can cover as few or as many users as you wish With updates supplied as soon as they’re available, you can be sure your documentation is current For further information, email bsmusales@bsigroup.com BSI Group Headquarters 389 Chiswick High Road London W4 4AL UK We continually improve the quality of our products and services to benefit your business If you find an inaccuracy or ambiguity within a British Standard or other BSI publication please inform the Knowledge Centre Copyright All the data, software and documentation set out in all British Standards and other BSI publications are the property of and copyrighted by BSI, or some person or entity that owns copyright in the information used (such as the international standardization bodies) and has formally licensed such information to BSI for commercial publication and use Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means – electronic, photocopying, recording or otherwise – without prior written permission from BSI Details and advice can be obtained from the Copyright & Licensing Department Useful Contacts: Customer Services Tel: +44 845 086 9001 Email (orders): orders@bsigroup.com Email (enquiries): cservices@bsigroup.com Subscriptions Tel: +44 845 086 9001 Email: subscriptions@bsigroup.com Knowledge Centre Tel: +44 20 8996 7004 Email: knowledgecentre@bsigroup.com Copyright & Licensing Tel: +44 20 8996 7070 Email: copyright@bsigroup.com