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
01-julij-2009
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SIST EN 60601-2-2:2008
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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
EC Directive MDD (93/42/EEC). See Annex ZZ.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.

- 3 - EN 60601-2-2:2009
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-2:2009 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 60601-2-18 + A1 NOTE  Harmonized as EN 60601-2-18:1996 + A1:2000 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replace the references to IEC 60601-1-2 and IEC 60601-1-8 by:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
Standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
safety and essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
Addition:
IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - EN 61000-4-3 2006
Part 4-3: Testing and measurement + IS1 2009
techniques - Radiated, radio-frequency,
electromagnetic field immunity test

1)
IEC 61000-4-6 2003 Electromagnetic compatibility (EMC) - EN 61000-4-6 2007
Part 4-6: Testing and measurement + corr. August 2007
techniques - Immunity to conducted + IS1 2009
disturbances, induced by radio-frequency
fields
2)
CISPR 11 (mod) 2003 Industrial scientific and medical (ISM) EN 55011 2007
radio-frequency equipment - Electromagnetic
disturbance characteristics - Limits and
methods of measurement
1)
EN 61000-4-6:2007 includes A1:2004 + A2:2006 to IEC 61000-4-6:2003. It is superseded by EN 61000-4-6:2009, which is
based on IEC 61000-4-6:2008.
2)
EN 55011:2007 includes A1:2004 (mod) to CISPR 11:2003 (mod).

- 5 - EN 60601-2-2:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
IEC 60601-2-2 ®
Edition 5.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.30 ISBN 2-8318-1029-9
– 2 – 60601-2-2 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.7
201.1 Scope, object and related standards .8
201.2 Normative references .9
201.3 Terms and definitions.10
201.4 General requirements.13
201.5 General requirements for testing of ME EQUIPMENT.14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .14
201.7 ME EQUIPMENT identification, marking and documents.14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.19
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.33
201.10 Protection against unwanted and excessive radiation HAZARDS.33
201.11 Protection against excessive temperatures and other HAZARDS.34
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.35
201.13 HAZARDOUS SITUATIONS and fault conditions.41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .42
201.15 Construction of ME EQUIPMENT .42
201.16 ME SYSTEMs .46
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .46
202 * Electromagnetic compatibility – Requirements and tests .46
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems.47
Annexes .47
Annex AA (informative) Particular guidance and rationale.48
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL
EQUIPMENT .70
Bibliography.79

Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT.14
HF ISOLATED PATIENT CIRCUIT .15
Figure 201.102 – Symbol used with a
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 .20
Figure 201.104 – Measurement of HF LEAKAGE CURRENT with NEUTR
...