IEC 60601-2-2:1998

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

Specifies requirements for the safety of high frequency surgical equipment used in medical practice. This third edition of IEC 60601-2-2 cancels and replaces the second edition published in 1991, and constitutes a technical revision.

General Information

• Status: Published
• Publication Date: 22-Sep-1998
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 19-Jul-2006

Relations

• Revised: IEC 60601-2-2:2006 - Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL
IEC
STANDARD
60601-2-2
Third edition
1998-09
Medical electrical equipment –
Part 2-2:
Particular requirements for the safety
of high frequency surgical equipment
Appareils électromédicaux –
Partie 2-2:
Règles particulières de sécurité pour appareils
d'électrochirurgie à courant haute fréquence

Reference number
IEC 60 601-2-2:1998(E)
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in
the 60 000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken by
the technical committee which has prepared this publication, as well as the list of
publications issued, is to be found at the following IEC sources:
• IEC web site*
• Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International Electro-
technical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60 617: Graphical symbols
for diagrams.
*  IEC web site http: //www.iec.ch.

INTERNATIONAL
IEC
STANDARD
60601-2-2
Third edition
1998-09
Medical electrical equipment –
Part 2-2:
Particular requirements for the safety
of high frequency surgical equipment
Appareils électromédicaux –
Partie 2-2:
Règles particulières de sécurité pour appareils
d'électrochirurgie à courant haute fréquence

 IEC 1998  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
X
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-2 © IEC:1998(E)
CONTENTS
Page
FOREWORD . 4

INTRODUCTION . 6

Clause
SECTION ONE – GENERAL
1 Scope and object . 7
2 Terminology and definitions. 8
3 General requirements. 9
4 General requirements for tests . 10
5 Classification . 10
6 Identification, marking and documents. 10
7 Power input. 13
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
14 Requirements related to classification . 14
17 Separation . 14
18 Protective earthing, functional earthing and potential equalization . 14
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 14
20 Dielectric strength . 17
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility . 18

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT . 19

60601-2-2 © IEC:1998(E) – 3 –
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES

AND OTHER SAFETY HAZARDS
42 Excessive temperatures . 19

44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,

disinfection and compatibility. 19

46 Human errors . 20

SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION

AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data . 21
51 Protection against hazardous output . 22
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions . 24
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly . 24
59 Construction and layout. 26
Figures 101 to 109. 29–33
Appendix L  References – Publications mentioned in this standard. 34
Annex AA (informative)  Guidance and rationale for particular clauses and subclauses. 35

– 4 – 60601-2-2 © IEC:1998(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION

––––––––––
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-2: Particular requirements for the safety

of high frequency surgical equipment

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-2 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition of IEC 60601-2-2 cancels and replaces the second edition published in 1991,
and constitutes a technical revision.

The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/291/FDIS 62D/297/RVD
Full information on the voting for the approval of this Particular Standard can be found in the
report on voting indicated in the above table.
Annex AA is for information only.

60601-2-2 © IEC:1998(E) – 5 –
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: in italic type;

–
TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD:

SMALL CAPITALS.
– 6 – 60601-2-2 © IEC:1998(E)
INTRODUCTION
The revisions for this third edition of the Particular Standard refer mainly to the following:

– Split NEUTRAL ELECTRODES are dealt with in more detail.

– Limitation of incorrect output power in SINGLE FAULT CONDITION.

– The requirements for AP EQUIPMENT are revised.

– White indicator lamps on coloured backgrounds for CUTTING and COAGULATION mode are no
longer allowed.
– Limitation of monitoring current to 100 μA for HF SURGICAL EQUIPMENT with BF or CF APPLIED
PARTS.
– Revised requirements for CREEPAGE DISTANCE and AIR CLEARANCE of APPLIED PARTS.
– Simultaneous activation of more than one PATIENT CIRCUIT is dealt with in more detail and a
compliance test method is now defined.

60601-2-2 © IEC:1998(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-2: Particular requirements for the safety

of high frequency surgical equipment

SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:

1 Scope and object
This clause of the General Standard applies except as follows:
*1.1  Scope
Addition:
HIGH FREQUENCY SURGICAL
This Particular Standard specifies requirements for the safety of
EQUIPMENT used in medical practice, as defined in 2.1.101 and hereinafter referred to as HF
SURGICAL EQUIPMENT.
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.
1.2  Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of HF
SURGICAL EQUIPMENT.
1.3  Particular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications consisting of
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1 (1991)
Amendment 2 (1995)
IEC 60601-1-1:1992, Medical electrical equipment – Part 1: General requirements for safety –
1: Collateral Standard: Safety requirements for medical electrical systems
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2: Collateral Standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4: Collateral Standard: Programmable electrical medical systems

– 8 – 60601-2-2 © IEC:1998(E)
For brevity, IEC 60601-1 is referred to, in this Particular Standard, either as the “General Standard”

or as the “General Requirement(s)”, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-4 as the

Collateral Standard(s).
The term "this Standard" covers the Particular Standard used together with the General

Standard and any Collateral Standards.

The numbering of sections, clauses and subclauses of this Particular Standard corresponds to

that of the General Standard. The changes to the text of the General Standard are specified by

the use of the following words:

“Replacement” means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
“Addition” means that the text of this Particular Standard is additional to the requirements of
the General Standard.
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
Clauses and subclauses for which there is a rationale are marked with an asterisk*. These
rationales can be found in an informative annex AA. Annex AA should be used in determining
the relevance of the requirements addressed but should never be used to establish additional
test requirements.
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