EN 80601-2-60:2015

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

IEC 80601-2-60:2012 applies to the basic safety and essential performance of Dental Units, Dental Patient Chairs, Dental Handpieces and Dental Operating Lights. Excluded are amalgamators, sterilizers and dental X-ray equipment.

Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Dental-Geräten

Appareils électromédicaux - Partie 2-60: Exigences particulières pour la sécurité de base et les performances essentielles des équipements dentaires

La CEI 80601-2-60:2012 s'applique à la sécurité de base et aux performances essentielles des Unités Dentaires, des Fauteuils Dentaires pour patient, des Outils à Main Dentaires et des Scialytiques. En sont exclus les vibreurs d'amalgame, les stérilisateurs et les équipements dentaires à rayonnement X.

Medicinska električna oprema - 2-60. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zobozdravstvene opreme

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI DENTALNIH ENOT, STOLOV ZA DENTALNE PACIENTE, DENTALNIH ROČNIH PRIPOMOČKOV IN DENTALNE OPERACIJSKE RAZSVETLJAVE, v nadaljevanju: ZOBOZDRAVSTVENA OPREMA. Izključeni so mešalni aparati, sterilizatorji in zobozdravstvena rentgenska oprema. 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.
Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Glej tudi točko 4.2 splošnega standarda.

General Information

• Status: Withdrawn
• Publication Date: 21-May-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Apr-2023
• Completion Date: 03-Apr-2023
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 80601-2-60:2015 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

Relations

• Replaced By: EN IEC 80601-2-60:2020 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
• Effective Date: 12-Jan-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 80601-2-60:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]RER]GUDYVWYHQHRSUHPH
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and
essential performance of dental equipment
Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen an die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Dental-Geräten
Appareils électromédicaux - Partie 2-60: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements dentaires
Ta slovenski standard je istoveten z: EN 80601-2-60:2015
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN 80601-2-60:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 80601-2-60:2015

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SIST EN 80601-2-60:2015


EUROPEAN STANDARD EN 80601-2-60

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.01

English Version
Medical electrical equipment - Part 2-60: Particular requirements
for the basic safety and essential performance of dental
equipment
(IEC 80601-2-60:2012)
Appareils électromédicaux - Partie 2-60: Exigences Medizinische elektrische Geräte -- Teil 2-60: Besondere
particulières pour la sécurité de base et les performances Festlegungen an die Sicherheit einschließlich der
essentielles des équipements dentaires wesentlichen Leistungsmerkmale von Dental-Geräten
(IEC 80601-2-60:2012) (IEC 80601-2-60:2012)
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 80601-2-60:2015 E

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SIST EN 80601-2-60:2015
EN 80601-2-60:2015 (E)

Foreword
The text of document 62D/964/FDIS, future edition 1 of IEC 80601-2-60, prepared by SC 62D,
"Electromedical equipment", of IEC/TC 62, "Electrical equipment in medical practice" and SC 6 "Dental
equipment" of ISO/TC 106 "Dentistry" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 80601-2-60:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national
standards conflicting with the
document have to be withdrawn

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 see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 80601-2-60:2012 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 61810-7:2006 NOTE  Harmonized as EN 61810-7:2006 (not modified).
ISO 13732-1:2006 NOTE  Harmonized as EN ISO 13732-1:2008 (not modified).
ISO 17664:2004 NOTE  Harmonized as EN ISO 17664:2004 (not modifie
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