Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

Establishes particular requirements for the safety of electromyographs and evoked response equipment as defined in clause 2 of this standard.

Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und Geräten für evozierte Potentiale

Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué

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

Status
Published
Publication Date
10-Jan-2019
Withdrawal Date
10-Jan-2022
Current Stage
6060 - Document made available - Publishing
Start Date
11-Jan-2019
Completion Date
11-Jan-2019

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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 o
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