SIST EN 60601-2-40:2019
(Main)Medical Electrical Equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment - Proposed Horizontal Standard (IEC 60601-2-40:2016)
Medical Electrical Equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment - Proposed Horizontal Standard (IEC 60601-2-40:2016)
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is
within the scope of this particular standard.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und Geräten für evozierte Potentiale (IEC 60601-2-40:2016)
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué - Proposition de norme horizontale (IEC 60601-2-40:2016)
L'IEC 60601-2-40:2016 s'applique à la sécurité de base et aux performances essentielles des électromyographes et des appareils à potentiel évoqué, désignés ci-après par appareils EM. Les appareils EM destinés à être utilisés avec les neurostimulateurs électriques transcutanés et les stimulateurs de muscles électriques sont exclus (couverts par l'IEC 60601-2-10). Cette deuxième édition annule et remplace la première édition de l'IEC 60601-2-40 parue en 1998. Cette édition constitue une révision technique.
Medicinska električna oprema - 2-40. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za elektromiografe in opremo za izzvane odzive (IEC 60601-2-40:2016)
Ta standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI za ELEKTROMIOGRAFE in OPREMO ZA IZZVANE ODZIVE, v nadaljevanju: MEDICINSKA ELEKTRIČNA OPREMA.
OPOMBA: Oprema myofeedback, kjer snemanje krčenja mišic temelji na elektromiografiji, je zajeta v področje uporabe tega standarda.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und Geräten für evozierte Potentiale (IEC 60601-2-40:2016)Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué - Proposition de norme horizontale (IEC 60601-2-40:2016)Medical Electrical Equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment - Proposed Horizontal Standard (IEC 60601-2-40:2016)11.040.50Radiografska opremaRadiographic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-40:2019SIST EN 60601-2-40:2019en01-marec-2019SIST EN 60601-2-40:2019SLOVENSKI
STANDARDSIST EN 60601-2-40:19981DGRPHãþD
SIST EN 60601-2-40:2019
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 60601-2-40
January 2019 ICS 11.040.20; 11.040.55; 11.040.99
Supersedes
EN 60601-2-40:1998
English Version
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (IEC 60601-2-40:2016)
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué (IEC 60601-2-40:2016)
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und Geräten für evozierte Potentiale (IEC 60601-2-40:2016) This European Standard was approved by CENELEC on 2016-09-22. 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, Serbia, 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: Rue de la Science 23,
B-1040 Brussels © 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-40:2019 E SIST EN 60601-2-40:2019
EN 60601-2-40:2019 (E) 2 European foreword The text of document 62D/1366/FDIS, future edition 2 of IEC 60601-2-40, prepared by IEC/TC 62 "Electrical equipment in medical practice"" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-40:2019. 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) 2019-07-11 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2022-01-11
This document supersedes EN 60601-2-40:1998. 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. Endorsement notice The text of the International Standard IEC 60601-2-40:2016 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-1-8 NOTE Harmonized as EN 60601-1-8. IEC 60601-2-10 NOTE Harmonized as EN 60601-2-10. IEC 62368-1 NOTE Harmonized as EN 62368-1. SIST EN 60601-2-40:2019
EN 60601-2-40:2019 (E) 3 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 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 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 Addition to Annex ZA of EN 60601-1:2006: IEC 60318 series
Electroacoustics - Simulators of human head and ear
EN 60318 series
ISO 15004-2 -
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection EN ISO 15004-2 -
SIST EN 60601-2-40:2019
SIST EN 60601-2-40:2019
IEC 60601-2-40 Edition 2.0 2016-08 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment –
Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Appareils électromédicaux –
Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE
ICS 11.040.20; 11.040.55; 11.040.99
ISBN 978-2-8322-3592-8
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale ®
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé. SIST EN 60601-2-40:2019
– 2 – IEC 60601-2-40:2016 IEC 2016 CONTENTS FOREWORD . 3 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references . 8 201.3 Terms and definitions . 9 201.4 General requirements . 10 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11 201.7 ME EQUIPMENT identification, marking and documents . 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10 Protection against unwanted and excessive radiation HAZARDS . 14 201.11 Protection against excessive temperatures and other HAZARDS . 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 14 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 16 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16 201.15 Construction of ME EQUIPMENT . 17 201.16 ME SYSTEMS . 17 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 17 202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 17 Annexes
........................................................................................................................... 22 Annex C (informative)
Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS . 22 Annex AA (informative)
Particular guidance and rationale . 23 Bibliography . 29 Index of defined terms used in this particular standard . 30
Figure AA.1 – Suggested test layout for EMISSION and IMMUNITY testing . 26 Figure AA.2 – Example of test setup for protection against the effects of HF SURGICAL ME EQUIPMENT . 27 Figure AA.3 – Example of test setup for protection against the effects of HF SURGICAL ME EQUIPMENT . 28
Table 202.101 – Pass/fail criteria for Table 4 of IEC 60601-1-2:2014 . 19 Table 202.102 – Pass/fail criteria for Table 7 of IEC 60601-1-2:2014 . 20 Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014 . 20 Table 201.C.101 – Marking on the outside of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT or its parts . 22
SIST EN 60601-2-40:2019
IEC 60601-2-40:2016 IEC 2016 – 3 – INTERNATIONAL ELECTROTECHNICAL COMMISSION _____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-40: Particular requirements for the basic safety and essential
performance of electromyographs and evoked response equipment
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 non-governmental 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 60601-2-40 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 60601-2-40 published in 1998. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) no special test phantom used for EMC testing; b) test method for continuous masking sound pressure level; c) test method for visual stimulators; SIST EN 60601-2-40:2019
– 4 – IEC 60601-2-40:2016 IEC 2016 d) allows use of equipment not intended for continuous operation; e) clarification that audible and visible indicators are not to be considered ALARM SYSTEMS as per IEC 60601-1-8. The text of this standard is based on the following documents: FDIS Report on voting 62D/1366/FDIS 62D/1394/RVD
Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 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. – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this document, the term –
“clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 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 document are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb: – “shall” means that compliance with a requirement or a test is mandatory for compliance with this document; – “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this document; – “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.
SIST EN 60601-2-40:2019
IEC 60601-2-40:2016 IEC 2016 – 5 – The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website 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.
SIST EN 60601-2-40:2019
– 6 – IEC 60601-2-40:2016 IEC 2016 INTRODUCTION This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT. It amends and supplements IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012), hereinafter referred to as the general standard. The aim of this second edition is to bring this particular standard up to date with reference to the latest edition of the general standard.
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 document 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 document.
SIST EN 60601-2-40:2019
IEC 60601-2-40:2016 IEC 2016 – 7 – MEDICAL ELECTRICAL EQUIPMENT –
Part 2-40: Particular requirements for the basic safety and essential
performance of electromyographs and evoked response equipment
201.1 Scope, object and related standards Clause 1 of the general standard1 applies, except as follows: 201.1.1 Scope Replacement: This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of this particular standard. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. The following
ME EQUIPMENT is excluded: ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10.) 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT [as defined in 201.3.201 and 201.3.202.] 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-8 and IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. ___________ 1 The general standard is IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance SIST EN 60601-2-40:2019
– 8 – IEC 60601-2-40:2016 IEC 2016 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”, where × is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.) 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 or applicable collateral standard is replaced completely by the text of this particular standard. "Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. "Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc. The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard. 201.2 Normative references Clause 2 of the general standard applies, except as follows: NOTE Informative references are listed in the bibliography beginning on page 29. SIST EN 60601-2-40:2019
IEC 60601-2-40:2016 IEC 2016 – 9 – Addition: IEC 60318 (all parts), Electroacoustics – Simulators of human head and ear ISO 15004-2, Ophthalmic instruments – Fundamental requirements and test methods – Part 2: Light hazard protection 201.3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: • IEC Electropedia: available at http://www.electropedia.org/ • ISO Online browsing platform: available at http://www.iso.org/obp NOTE An index of defined terms is found beginning on page 30. Addition: 201.3.201 ELECTROMYOGRAPH ME EQUIPMENT for the detection or recording of biopotentials accompanying nerve and muscle action, either spontaneously, intentionally or evoked by electrical or other stimulation 201.3.202 EVOKED RESPONSE EQUIPMENT ME EQUIPMENT for the detection or recording of biopotentials resulting from an evoking stimulus Note 1 to entry: The stimulus may be electrical, tactile, auditory, visual, olfactory, etc. 201.3.203 ELECTRICAL STIMULATOR part of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT for the application of electric currents via ELECTRODES in direct contact with the PATIENT, for the evoking of biopotentials
201.3.204 PULSE DURATION duration of the electrical stimulus pulse WAVEFORM at 50% of the peak amplitude 201.3.205 WAVEFORM variations in magnitude of an electrical stimulus output (either voltage or current) as a function of time appearing in the APPLIED PART(S) of the ELECTRICAL STIMULATOR or the collected biopotentials by the BIOPOTENTIALS INPUT PART 201.3.206 AUDITORY STIMULATOR part of ELECTROMYOGRAPHS and EVOKED RESPONSE 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 SIST EN 60601-2-40:2019
– 10 – IEC 60601-2-40:2016 IEC 2016 201.3.207 VISUAL STIMULATOR part of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT for the application of pulsed electromagnetic radiation in the visible spectrum from a transducer to the eyes of the PATIENT, for the evoking of biopotentials 201.3.208 BIOPOTENTIAL INPUT PART APPLIED PART(S) of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT for the collection of biopotentials 201.3.209 ELECTRODE conductive portion that is applied to the PATIENT to detect electrical activity and/or to apply the stimulus from the ELECTRICAL STIMULATOR to the PATIENT 201.3.210 PATIENT LEAD cable connected between an ELECTRODE and either a PATIENT CABLE or the ME EQUIPMENT 201.3.211 PATIENT CABLE multiwire cable used to connect PATIENT LEADS
to ME EQUIPMENT 201.4 General requirements Clause 4 of the general standard applies, except as follows: 201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS Addition: MANUFACTURERS shall include, within their RISK MANAGEMENT FILE, the RISK associated with the potential use of their STIMULATORS and accessories to deliver current exceeding 10 mA r.m.s or current densities for any ELECTRODE exceeding 2 mA/cm2. 201.4.3 ESSENTIAL PERFORMANCE Addition: NOTE Because of the variety of clinical applications for ELECTROMYOGRAPHS and EVOKED RESPONSE, no additional ESSENTIAL PERFORMANCE is specified in this particular standard. However, ESSENTIAL PERFORMANCE shall be determined by the manufacturer in accordance with the requirements of sub-clause 4.3 of the general standard. 201.4.11 Power input Replacement: The power input is measured with a load resistance of the lowest value specified in the technical description (see 201.7.9.3.101 a)), and with any output controls set to result in maximum power input. 201.5 General requirements for testing of ME EQUIPMENT Clause 5 of the general standard applies, except as follows. SIST EN 60601-2-40:2019
IEC 60601-2-40:2016 IEC 2016 – 11 – 201.5.4 Other conditions Addition: Where values of voltage and current are used in this document, they mean the r.m.s. values of an alternating, direct or composite voltage or current averaged over 1 s unless stated otherwise. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies, except as follows: 201.6.2 * Protection against electric shock Amendment: Delete TYPE B APPLIED PART. 201.7 ME EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows: 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 201.7.2.3 * Consult accompanying documents Replacement:
Safety sign ISO 7010-M002 shall be used (see Table D.2, safety sign 10 in Annex D of the general standard). 201.7.2.7 Electrical input power from the SUPPLY MAINS Replacement: The RATED power input of MAINS operated ME EQUIPMENT shall be the maximum power input averaged over any period of 5 s under the specified operating conditions set out by the manufacturer. 201.7.2.8 Output connectors 201.7.2.8.2 Other power sources Addition: See also 201.12.4.102. 201.7.2.13 * Physiological effects (safety signs and warning statements) ME EQUIPMENT capable of delivering electrical stimulus outputs into a load resistance of 1 000 Ω 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 the safety sign ISO 7010-M002
(see safety sign No. 10 in Table D.2 of Annex D of the general standard). SIST EN 60601-2-40:2019
– 12 – IEC 60601-2-40:2016 IEC 2016 201.7.4 Marking of controls and instruments 201.7.4.2 * Control devices Replacement: An output control for the ELECTRICAL STIMULATOR shall be incorporated which will control the ELECTRICAL STIMULATOR output from minimum to maximum of the range continuously, or in discrete increments of not more than 1 mA peak amplitude or 5 V peak amplitude per increment. At its minimum setting, the output shall not exceed 2 % of that available at the maximum setting of the control.
The type of stimulator out
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