EN 60601-2-2:2007

Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

This Particular Standard specifies requirements for the safety of high frequency surgical equipment and hf surgical accessories used in medical practice. 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.

Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit von Hochfrequenz-Chirurgiegeräten

Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité des appareils d'électrochirurgie à courant haute fréquence

La présente Norme Particulière spécifie des exigences relatives à la sécurité des appareils d'électrochirurgie hf et des accessoires d'électrochirurgie hf utilisés dans la pratique médicale. Les appareils d'électrochirurgie à courant haute fréquence 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.

Medicinska električna oprema - 2-2. del: Posebne zahteve za varnost visokofrekvenčne kirurške opreme (IEC 60601-2-2:2006)

General Information

• Status: Withdrawn
• Publication Date: 28-Mar-2007
• Withdrawal Date: 30-Sep-2009
• 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
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Apr-2012
• Completion Date: 01-Apr-2012
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning 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 60601-2-2:2008 - Medical electrical equipment -- Part 2-2: Particular requirements for the safety of high frequency surgical equipment

Relations

• Replaces: EN 60601-2-2:2000 - Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
• Effective Date: 29-Jan-2023
• Replaced By: 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: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-2:2008
01-oktober-2008
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SIST EN 60601-2-2:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DYDUQRVW
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Medical electrical equipment - Part 2-2: Particular requirements for the safety of high
frequency surgical equipment (IEC 60601-2-2:2006)
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
von Hochfrequenz-Chirurgiegeräten (IEC 60601-2-2:2006)
Appareils électromédicaux - Partie 2-2: Exigences particulieres pour la sécurité des
appareils d'électrochirurgie a courant haute fréquence (IEC 60601-2-2:2006)
Ta slovenski standard je istoveten z: EN 60601-2-2:2007
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN 60601-2-2:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-2:2008

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SIST EN 60601-2-2:2008


EUROPEAN STANDARD
EN 60601-2-2

NORME EUROPÉENNE
March 2007
EUROPÄISCHE NORM

ICS 11.040.30 Supersedes EN 60601-2-2:2000


English version


Medical electrical equipment -
Part 2-2: Particular requirements for the safety
of high frequency surgical equipment
(IEC 60601-2-2:2006)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-2: Exigences particulières Teil 2-2: Besondere Festlegungen
pour la sécurité des appareils für die Sicherheit
d'électrochirurgie à courant von Hochfrequenz-Chirurgiegeräten
haute fréquence (IEC 60601-2-2:2006)
(CEI 60601-2-2:2006)




This European Standard was approved by CENELEC on 2006-10-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-2:2007 E

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SIST EN 60601-2-2:2008
EN 60601-2-2:2007 - 2 -
Foreword
The text of document 62D/548/FDIS, future edition 4 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 was approved by CENELEC as EN 60601-2-2 on 2006-10-01.
This European Standard supersedes EN 60601-2-2:2000.
Significant revisions in EN 60601-2-2:2007 refer mainly to the following:
– revision of requirements and compliance testing for HF SURGICAL ACCESSORIES to make them
independent of specific HF surgical generators;
– revision and expansion of Clause 2 definitions;
– addition of thermal, electrical and adhesive requirements testing for NEUTRAL ELECTRODES;
– revision of dielectric strength requirements for HF SURGICAL ACCESSORIES;
– accommodation of HF surgical generators that don’t require continuous operation of the SWITCH
SENSOR;
– addition of Annex BB to provide EMD information about HF SURGICAL EQUIPMENT.
This Particular Standard amends and supplements EN 60601-1:1990, Medical Electrical Equipment –
Part 1: General requirements for safety, and its amendments, hereinafter referred to as the General
Standard. The requirements of this Particular Standard take priority over those of the General Standard.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2007-10-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2009-10-01
with the EN have to be withdrawn
In this Particular Standard the following print types are used:
– requirements, com
...