EN 60601-2-18:2015

Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include: - alignment of requirements with IEC 60601-1:2005; - inclusion of essential performance requirements; - the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; - reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.

Medizinische elektrische Geräte - Teil 2-18: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von endoskopischen Geräten

Appareils électromédicaux - Partie 2-18: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'endoscopie

La CEI 60601-2-18:2009 établit les exigences particulières pour la sécurité de base et les performances essentielles des appareils d'endoscopie. Les exigences de sécurité minimales spécifiées dans la présente norme particulière fournissent un degré de sécurité pratique pour le fonctionnement des appareils d'endoscopie. La CEI 60601-2-18:2009 modifie et complète la CEI 60601-1:2005. Cette troisième édition annule et remplace la deuxième édition, publiée en 1996 et son Amendement 1 (2000). Cette édition constitue une révision technique et est alignée ou harmonisée avec la CEI 60601-1:2005. Les modifications principales par rapport à l'édition précédente sont les suivantes: - l'alignement des exigences avec la CEI 60601-1-2005; - l'inclusion des exigences relatives aux performances essentielles; - l'inclusion des endoscopes alimentés et des appareils d'endothérapie alimentés utilisés pour des ponctions secondaires et ultérieures dans le cadre du domaine d'application de la norme; - la référence à la CEI 60601-2-2 pour les essais de tension de tenue des appareils d'endothérapie alimentés par courant HF, plutôt que la définition d'essais différents.

Medicinska električna oprema - 2-18. del: Posebne zahteve za osnovno varnost in bistvene lastnosti endoskopske opreme

IEC 60601-2-18:2009 vzpostavlja posebne zahteve glede osnovne varnosti in bistvenih lastnosti endoskopske opreme. Minimalne varnostne zahteve, navedene v tem standardu, se uporabljajo za določitev praktične stopnje varnosti pri upravljanju endoskopske opreme. IEC 60601-2-18:2009 dopolnjuje in izpolnjuje IEC 60601-1:2005. Ta tretja izdaja razveljavlja in nadomešča drugo izdajo, objavljeno leta 1996, ter njeno dopolnilo 1 (2000). Ta izdaja tvori tehnično popravljeno izdajo in je usklajena ali harmonizirana s standardom IEC 60601-1:2005. Glavne spremembe glede na predhodno različico: – uskladitev zahtev s standardom IEC 60601-1:2005; – vključitev zahtev glede bistvenih lastnosti; –vključitev endoskopov z napajanjem ter endoterapevtskih naprav z napajanjem, ki se uporabljajo pri sekundarnem predrtju in naslednjih predrtjih znotraj področja uporabe tega standarda; – sklic na IEC 60601-2-2 za preskušanje dielektrične moči endoterapevtskih naprav HF z napajanjem namesto določevanja različnih preskusov.

General Information

• Status: Published
• Publication Date: 22-Oct-2015
• Withdrawal Date: 14-Sep-2018
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 23-Oct-2015
• Completion Date: 23-Oct-2015
• 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 60601-2-18:2015 - Medical electrical equipment -- Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment

Relations

• Replaces: EN 60601-2-18:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-2-18:1996/A1:2000 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-18:2015
01-december-2015
1DGRPHãþD
SIST EN 60601-2-18:1998
SIST EN 60601-2-18:1998/A1:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLHQGRVNRSVNHRSUHPH
Medical electrical equipment -- Part 2-18: Particular requirements for basic safety and
essential performance of endoscopic equipment
Medizinische elektrische Geräte - Teil 2-18: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von endoskopischen Geräten
Appareils électromedicaux -- Partie 2-18: Exigences particulières pour la sécurité de
base et les performances essentielles des appareils d’endoscopie
Ta slovenski standard je istoveten z: EN 60601-2-18:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-18:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-18:2015

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SIST EN 60601-2-18:2015


EUROPEAN STANDARD EN 60601-2-18

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2015
ICS 11.040.50 Supersedes EN 60601-2-18:1996
English Version
Medical electrical equipment - Part 2-18: Particular requirements
for the basic safety and essential performance of endoscopic
equipment
(IEC 60601-2-18:2009)
Appareils électromédicaux - Partie 2-18: Exigences Medizinische elektrische Geräte - Teil 2-18: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils d'endoscopie wesentlichen Leistungsmerkmale von endoskopischen
(IEC 60601-2-18:2009) Geräten
(IEC 60601-2-18:2009)
This European Standard was approved by CENELEC on 2015-09-15. 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 60601-2-18:2015 E

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SIST EN 60601-2-18:2015
EN 60601-2-18:2015
European foreword
The text of document 62D/682/CDV, future edition 3 of IEC 60601-2-18, 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 60601-2-18:2015.
The following dates are fixed:
(dop) 2016-06-15
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-18:1996.
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 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-18:2009 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated :
IEC 60601-2-57 NOTE Harmonized as EN 60601-2-57.
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