EN 60601-2-40:2019

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

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

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

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 -
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
– 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
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 A
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