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• Status: Withdrawn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
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– test specifications and headings of items: in italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS.
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 93/42/EEC (MDD). See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-2:2006 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 60601-2-2:2007
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.
Publication Year Title EN/HD Year

IEC 60601-1-2 2001 Medical electrical equipment - EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests

IEC 60601-2-2 1998 Medical electrical equipment - EN 60601-2-2 2000
Part 2-2: Particular requirements for the
safety of high frequency surgical equipment

IEC 60601-2-4 2005 Medical electrical equipment - - -
Part 2-4: Particular requirements for the
safety of cardiac defibrillators

IEC 60601-2-18 1996 Medical electrical equipment - EN 60601-2-18 1996
A1 2000 Part 2-18: Particular requirements for the A1 2000
safety of endoscopic equipment

IEC 60601-2-34 2000 Medical electrical equipment - EN 60601-2-34 2000
Part 2-34: Particular requirements for the
safety, including essential performance, of
invasive blood pressure monitoring
equipment
IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - EN 61000-4-3 2006
Part 4-3 : Testing and measurement
techniques - Radiated, radio-frequency,
electromagnetic field immunity test

IEC 61000-4-6 2003 Electromagnetic compatibility (EMC) -
1)
+ A1 2004 Part 4-6: Testing and measurement EN 61000-4-6 200X
techniques - Immunity to conducted
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)
To be ratified; will also include A2:2006 to IEC 61000-4-6.
2)
EN 55011 includes A1:2004 to CISPR 11.

Publication Year Title EN/HD Year
CISPR 16-2-1 2003 Specification for radio disturbance and EN 55016-2-1 2004
immunity measuring apparatus and methods -
Part 2-1: Methods of measurement of
disturbances and immunity - Conducted
disturbance measurements
ANSI/AAMI HF18 2001 Electrosurgical devices - -

- 5 - EN 60601-2-2:2007
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 Directives concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
NORME CEI
INTERNATIONALE
IEC
60601-2-2
INTERNATIONAL
Quatrième édition
STANDARD
Fourth edition
2006-07
Appareils électromédicaux –
Partie 2-2:
Exigences particulières pour la sécurité
des appareils d’électrochirurgie à courant
haute fréquence
Medical electrical equipment –
Part 2-2:
Particular requirements for the safety
of high frequency surgical equipment

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60601-2-2 © IEC:2006 – 3 –
CONTENTS
FOREWORD.7
INTRODUCTION.11

SECTION ONE – GENERAL
1 Scope and object.13
2 Terminology and definitions.15
3 General requirements .23
4 General requirements for tests .23
5 Classification.23
6 Identification, marking and documents.25
7 Power input .33

SECTION TWO – ENVIRONMENTAL CONDITIONS

SECTION THREE – PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
14 Requirements related to classification .35
17 Separation.35
18 Protective earthing, functional earthing and potential equalization.35
*19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .35
*20 Dielectric strength .49

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility .51

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT .53

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
*42 Excessive temperatures .53
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.53
46 Human errors .57

60601-2-2 © IEC:2006 – 5 –
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data .59
51 Protection against hazardous output.63

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .69

SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .69
59 Construction and layout.79

Appendix L References – Publications mentioned in this standard .99
Annex AA (informative) Guidance and rationale for particular clauses and subclauses.101
Annex BB (informative) Electromagnetic disturbances created by HF SURG
...