EN IEC 60601-2-2:2018

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

NEW!IEC 60601-2-2:2017 is available as IEC 60601-2-2:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories. HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements. The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - refinement and additions to the defined terms; - additional separation of the requirements for HF surgical equipment and HF surgical accessories; - a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes; - new requirements for devices that have or use a high current mode.

Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten

Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'électrochirurgie à courant haute fréquence et des accessoires d'électrochirurgie à courant haute fréquence

NEW!IEC 60601-2-2:2017 est disponible sous forme de IEC 60601-2-2:2017 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-2:2017 s’applique à la sécurité de base et aux performances essentielles des appareils d’électrochirurgie HF et des accessoires d'électrochirurgie HF. Les appareils d’électrochirurgie HF dont la puissance de sortie assignée est inférieure ou égale à 50 W (destinés, par exemple, à la micro coagulation, à l’ophtalmologie ou à l’usage dentaire) sont exemptés de certaines exigences de la présente norme particulière. Ces exemptions sont indiquées dans les exigences correspondantes. La présente norme particulière a pour objet d’établir des exigences particulières relatives à la sécurité de base et aux performances essentielles des appareils d’électrochirurgie HF et des accessoires d’électrochirurgie HF. Cette sixième édition annule et remplace la cinquième édition parue en 2009. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: - des précisions et des ajouts aux termes définis; - une séparation supplémentaire des exigences relatives aux appareils d'électrochirurgie à courant haute fréquence (HF) et aux accessoires d'électrochirurgie à courant haute fréquence (HF); - une nouvelle exigence concernant les électrodes neutres adultes devant servir d'électrodes neutres de surveillance de la qualité du contact; - de nouvelles exigences relatives aux appareils ayant ou utilisant un mode de courant élevé.

Medicinska električna oprema - 2-2. del: Posebne zahteve za osnovno varnost in bistvene lastnosti visokofrekvenčne kirurške opreme in visokofrekvenčnega kirurškega pribora (IEC 60601-2-2:2017)

Ta del standarda IEC 60601 velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI VISOKOFREKVENČNE KIRURŠKE OPREME in VISOKOFREKVENČNEGA KIRURŠKEGA PRIBORA, kot sta opredeljena v 201.3.224 in 201.3.223. VISOKOFREKVENČNA KIRURŠKA OPREMA z NAZIVNO IZHODNO MOČJO so 50 W (na primer za mikro-KOAGULACIJO ali za uporabo v zobozdravstvu ali oftalmologiji) je izvzeta iz določenih zahtev tega standarda. Te izjeme so navedene pri ustreznih zahtevah.

General Information

• Status: Published
• Publication Date: 17-May-2018
• Withdrawal Date: 17-May-2021
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 18-May-2018
• Completion Date: 18-May-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN IEC 60601-2-2:2018 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2017)

Relations

• Replaces: EN 60601-2-2:2009/A11:2011 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 23-Jan-2023
• Replaces: EN 60601-2-2:2009 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 07-Jun-2022
• Amended By: EN IEC 60601-2-2:2018/FprA1:2022 - Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 01-Jun-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-2:2018
01-julij-2018
1DGRPHãþD
SIST EN 60601-2-2:2009
SIST EN 60601-2-2:2009/A11:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLYLVRNRIUHNYHQþQHNLUXUãNHRSUHPHLQYLVRNRIUHNYHQþQHJD
NLUXUãNHJDSULERUD,(&
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and
essential performance of high frequency surgical equipment and high frequency surgical
accessories (IEC 60601-2-2:2017)
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten
und HF-chirurgischem Zubehör (IEC 60601-2-2:2017)
Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'électrochirurgie à courant haute
fréquence et des accessoires d'électrochirurgie à courant haute fréquence (IEC 60601-2-
2:2017)
Ta slovenski standard je istoveten z: EN IEC 60601-2-2:2018
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN IEC 60601-2-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-2:2018

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SIST EN IEC 60601-2-2:2018


EUROPEAN STANDARD EN IEC 60601-2-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2018
ICS 11.040.30 Supersedes EN 60601-2-2:2009
English Version
Medical electrical equipment - Part 2-2: Particular requirements
for the basic safety and essential performance of high frequency
surgical equipment and high frequency surgical accessories
(IEC 60601-2-2:2017)
Appareils électromédicaux - Partie 2-2: Exigences Medizinische elektrische Geräte - Teil 2-2: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils d'électrochirurgie à courant haute wesentlichen Leistungsmerkmale von Hochfrequenz-
fréquence et des accessoires d'électrochirurgie à courant Chirurgiegeräten
haute fréquence (IEC 60601-2-2:2017)
(IEC 60601-2-2:2017)
This European Standard was approved by CENELEC on 2017-05-05. 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
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60601-2-2:2018 E

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SIST EN IEC 60601-2-2:2018
EN IEC 60601-2-2:2018 (E)
European foreword
The text of document 62D/1427/FDIS, future edition 6 of IEC 60601-2-2, 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 60601-2-2:2018.

The following dates are fixed:
(dop) 2018-11-18
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2021-05-18
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-2:2009.

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.

Endorsement notice
The text of the International Standard IEC 60602-2-2:2017 was approved by CENELEC as a
European Standard wit
...