EN IEC 80601-2-60:2020
(Main)Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
IEC 80601-2-60:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES AND DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT. 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. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. IEC 80601-2-60:2019 cancels and replaces the first edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Dental-Geräten
Appareils électromédicaux - Partie 2-60: Exigences particulères pour la sécurité de base et les performances essentielles des équipements dentaires
IEC 80601-2-60:2019 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des UNITES DENTAIRES, des FAUTEUILS DENTAIRES PATIENT, des PIECES A MAIN DENTAIRES et des SCIALYTIQUES, désignés ci-après sous le terme EQUIPEMENTS DENTAIRES. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si ce n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d’application du présent document ne sont pas couverts par des exigences spécifiques du présent document, à l’exception de 7.2.13 et de 8.4.1 de la norme générale. IEC 80601-2-60:2019 annule et remplace la première édition parue en 2012. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) alignement sur l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD1:2012.
Medicinska električna oprema - 2-60. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zobozdravstvene opreme (IEC 80601-2-60:2019)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 80601-2-60:2020
01-junij-2020
Nadomešča:
SIST EN 80601-2-60:2015
Medicinska električna oprema - 2-60. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti zobozdravstvene opreme (IEC 80601-2-60:2019)
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and
essential performance of dental equipment (IEC 80601-2-60:2019)
Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Dental-Geräten (IEC 80601-2-
60:2019)
Appareils électromédicaux - Partie 2-60: Exigences particulères pour la sécurité de base
et les performances essentielles des équipements dentaires (IEC 80601-2-60:2019)
Ta slovenski standard je istoveten z: EN IEC 80601-2-60:2020
ICS:
11.060.20 Zobotehnična oprema Dental equipment
SIST EN IEC 80601-2-60:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 80601-2-60:2020
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SIST EN IEC 80601-2-60:2020
EUROPEAN STANDARD EN IEC 80601-2-60
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.01 Supersedes EN 80601-2-60:2015 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-60: Particular requirements
for the basic safety and essential performance of dental
equipment
(IEC 80601-2-60:2019)
Appareils électromédicaux - Partie 2-60: Exigences Medizinische elektrische Geräte - Teil 2-60: Besondere
particulères pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des équipements dentaires wesentlichen Leistungsmerkmale von Dental-Geräten
(IEC 80601-2-60:2019) (IEC 80601-2-60:2019)
This European Standard was approved by CENELEC on 2019-08-01. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, 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
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-60:2020 E
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SIST EN IEC 80601-2-60:2020
EN IEC 80601-2-60:2020 (E)
European foreword
The text of document 62D/1683/FDIS, future edition 2 of IEC 80601-2-60, 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 IEC 80601-2-60:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
document have to be withdrawn
This document supersedes EN 80601-2-60:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC 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.
Endorsement notice
The text of the International Standard IEC 80601-2-60:2019 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 60038 NOTE Harmonized as EN 60038
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 61810-7:2006 NOTE Harm
...
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