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

IEC 60601-2-2:2009 specifies particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This fifth edition cancels and replaces the fourth edition published in 2006. This edition constitutes a technical revision. Revisions in this edition include new language for preconditioning accessories prior to insulation testing, refining the requirements for electromagnetic compatibility testing and correcting some of the equations used in deriving the thermal test for neutral electrodes.

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

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

La CEI 60601-2-2:2009 spécifie des 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. La présente norme particulière modifie et complète la CEI 60601-1 (troisième édition, 2005): Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. Cette cinquième édition annule et remplace la quatrième édition publiée en 2006 dont elle constitue une révision technique. Les révisions de la présente édition incluent de nouveaux termes relatifs au préconditionnement des accessoires préalablement à l'essai d'isolement, à l'affinement des exigences applicables aux essais de compatibilité électromagnétique et à la correction de certaines équations utilisées dans le calcul de l'essai thermique applicable aux électrodes neutres.

Medicinska električna oprema - 2.2. del: Posebne zahteve za osnovno varnost in bistvene lastnosti visokofrekvenčne kirurške opreme in visokofrekvenčnega kirurškega pribora (IEC 60601-2-2:2009)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI HF KIRURŠKE OPREME, kot je določeno v 201.3.222. HF KIRURŠKA OPREMA, ki ima OCENJENO IZHODNO MOČ manjšo od 50 W (na primer za mikroKOAGULACIJO ali za uporabo v zobozdravstvu ali oftamologiji), je izvzeta iz določenih zahtev tega konkretnega standarda. Te izjeme so navedene v ustreznih zahtevah.

General Information

• Status: Withdrawn
• Publication Date: 19-May-2009
• Withdrawal Date: 31-Mar-2012
• 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: 18-May-2021
• Completion Date: 18-May-2021
• 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 60601-2-2:2009 - Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009)

Relations

• Replaces: EN 60601-2-2:2007 - Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
• Effective Date: 29-Jan-2023
• Replaced By: 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
• Effective Date: 07-Jun-2022
• Amended By: 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: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-2:2009
01-julij-2009
1DGRPHãþD
SIST EN 60601-2-2:2008
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLYLVRNRIUHNYHQþQHNLUXUãNHRSUHPHLQYLVRNRIUHNYHQþQHJD
NLUXUãNHJDSULERUD,(&
Medical electrical equipment - Part 2-2: Particular requirements for basic safety and
essential performance of high frequency surgical equipment and high frequency surgical
accessories (IEC 60601-2-2:2009)
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten
(IEC 60601-2-2:2009)
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 (CEI 60601-2-
2:2009)
Ta slovenski standard je istoveten z: EN 60601-2-2:2009
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN 60601-2-2:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-2-2:2009

---------------------- Page: 2 ----------------------

SIST EN 60601-2-2:2009

EUROPEAN STANDARD
EN 60601-2-2

NORME EUROPÉENNE
May 2009
EUROPÄISCHE NORM

ICS 11.040.30 Supersedes EN 60601-2-2:2007


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 60601-2-2:2009)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-2: Exigences particulières Teil 2-2: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des appareils d'électrochirurgie von Hochfrequenz-Chirurgiegeräten
à courant haute fréquence und HF-chirurgischem Zubehör
et des accessoires d'électrochirurgie (IEC 60601-2-2:2009)
à courant haute fréquence
(CEI 60601-2-2:2009)


This European Standard was approved by CENELEC on 2009-04-01. 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: Avenue Marnix 17, B - 1000 Brussels


© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-2:2009 E

---------------------- Page: 3 ----------------------

SIST EN 60601-2-2:2009
EN 60601-2-2:2009 - 2 -
Foreword
The text of document 62D/726/FDIS, future edition 5 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 2009-04-01.
This European Standard supersedes EN 60601-2-2:2007.
Revisions in EN 60601-2-2:2009 include new language for preconditioning accessories prior to insulation
testing, refining the requirements for electromagnetic compatibility testing and correcting some of the
equations used in deriving the thermal test for NEUTRAL ELECTRODES.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2010-01-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-04-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
...