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 60601-2-2:2017)

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF
SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
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 einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten und HF-chirurgischem Zubehör (IEC 60601-2-2:2017)

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 (IEC 60601-2-2:2017)

NEW!IEC 60601-2-2:2017 est disponible sous forme de IEC 60601-2-2:2017 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-2:2017 s’applique à la sécurité de base et aux performances essentielles des appareils d’électrochirurgie HF et des accessoires d'électrochirurgie HF. Les appareils d’électrochirurgie HF 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. La présente norme particulière a pour objet d’établir des exigences particulières relatives à la sécurité de base et aux performances essentielles des appareils d’électrochirurgie HF et des accessoires d’électrochirurgie HF. Cette sixième édition annule et remplace la cinquième édition parue en 2009. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: - des précisions et des ajouts aux termes définis; - une séparation supplémentaire des exigences relatives aux appareils d'électrochirurgie à courant haute fréquence (HF) et aux accessoires d'électrochirurgie à courant haute fréquence (HF); - une nouvelle exigence concernant les électrodes neutres adultes devant servir d'électrodes neutres de surveillance de la qualité du contact; - de nouvelles exigences relatives aux appareils ayant ou utilisant un mode de courant élevé.

Medicinska električna oprema - 2-2. del: Posebne zahteve za osnovno varnost in bistvene lastnosti visokofrekvenčne kirurške opreme in visokofrekvenčnega kirurškega pribora (IEC 60601-2-2:2017)

Ta del standarda IEC 60601 velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI VISOKOFREKVENČNE KIRURŠKE OPREME in VISOKOFREKVENČNEGA KIRURŠKEGA PRIBORA, kot sta opredeljena v 201.3.224 in 201.3.223. VISOKOFREKVENČNA KIRURŠKA OPREMA z NAZIVNO IZHODNO MOČJO so 50 W (na primer za mikro-KOAGULACIJO ali za uporabo v zobozdravstvu ali oftalmologiji) je izvzeta iz določenih zahtev tega standarda. Te izjeme so navedene pri ustreznih zahtevah.

General Information

Status
Published
Publication Date
03-Jun-2018
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-May-2018
Due Date
29-Jul-2018
Completion Date
04-Jun-2018

RELATIONS

Buy Standard

Standard
SIST EN IEC 60601-2-2:2018
English language
93 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-2:2018
01-julij-2018
1DGRPHãþD
SIST EN 60601-2-2:2009
SIST EN 60601-2-2:2009/A11:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLYLVRNRIUHNYHQþQHNLUXUãNHRSUHPHLQYLVRNRIUHNYHQþQHJD
NLUXUãNHJDSULERUD ,(&

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 60601-2-2:2017)

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

einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten

und HF-chirurgischem Zubehör (IEC 60601-2-2:2017)

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 (IEC 60601-2-

2:2017)
Ta slovenski standard je istoveten z: EN IEC 60601-2-2:2018
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN IEC 60601-2-2:2018 en

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

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-2:2018
---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-2:2018
EUROPEAN STANDARD EN IEC 60601-2-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2018
ICS 11.040.30 Supersedes EN 60601-2-2:2009
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 60601-2-2:2017)

Appareils électromédicaux - Partie 2-2: Exigences Medizinische elektrische Geräte - Teil 2-2: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des appareils d'électrochirurgie à courant haute wesentlichen Leistungsmerkmale von Hochfrequenz-

fréquence et des accessoires d'électrochirurgie à courant Chirurgiegeräten
haute fréquence (IEC 60601-2-2:2017)
(IEC 60601-2-2:2017)

This European Standard was approved by CENELEC on 2017-05-05. 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 CEN-CENELEC

Management Centre 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 CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,

Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 60601-2-2:2018 E
---------------------- Page: 3 ----------------------
SIST EN IEC 60601-2-2:2018
EN IEC 60601-2-2:2018 (E)
European foreword

The text of document 62D/1427/FDIS, future edition 6 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 approved by CENELEC as EN IEC 60601-2-2:2018.
The following dates are fixed:
(dop) 2018-11-18
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2021-05-18
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-2:2009.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 60602-2-2:2017 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards indicated:

IEC 60529 NOTE Harmonized as EN 60529.
IEC 60601-2-4:2010 NOTE Harmonized as EN 60601-2-4:2011.
IEC 60601-2-18:2009 NOTE Harmonized as EN 60601-2-18:2015.
---------------------- Page: 4 ----------------------
SIST EN IEC 60601-2-2:2018
EN IEC 60601-2-2:2018 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),

the relevant EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is

available here: www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: General 2015
EN 60601-1-2
requirements for basic safety and essential
performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests

IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General EN 60601-1-8 2007

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
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:2006:
CISPR 11 2015 Industrial, scientific and medical equipment - EN 55011 2016
Radio-frequency disturbance characteristics -
Limits and methods of measurement

IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - Part 4-3: EN 61000-4-3 2006

Testing and measurement techniques -
Radiated, radio-frequency, electromagnetic
field immunity test

IEC 61000-4-6 2013 Electromagnetic compatibility (EMC) - Part 4-6: EN 61000-4-6 2014

Testing and measurement techniques -
Immunity to conducted disturbances, induced
by radio-frequency fields
---------------------- Page: 5 ----------------------
SIST EN IEC 60601-2-2:2018
---------------------- Page: 6 ----------------------
SIST EN IEC 60601-2-2:2018
IEC 60601-2-2
Edition 6.0 2017-03
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
INTERNATIONALE
ICS 11.040.30 ISBN 978-2-8322-4008-3

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN IEC 60601-2-2:2018
– 2 – IEC 60601-2-2:2017  IEC 2017
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 .............................................................................................. 14

201.5 General requirements for testing of ME EQUIPMENT ................................................... 15

201.6 Classification of ME EQUIPMENT and ME SYSTEMS ...................................................... 15

201.7 ME EQUIPMENT identification, marking and documents .............................................. 15

201.8 Protection against electrical HAZARDS from ME EQUIPMENT ........................................ 20

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .............. 36

201.10 Protection against unwanted and excessive radiation HAZARDS ................................ 36

201.11 Protection against excessive temperatures and other HAZARDS ................................ 36

201.12 Accuracy of controls and instruments and protection against hazardous

outputs .................................................................................................................... 38

201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ................................. 43

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................... 44

201.15 Construction of ME EQUIPMENT ................................................................................. 44

201.16 ME SYSTEMS ............................................................................................................ 49

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ............................. 49

202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests .................................. 49

208 General requirements, tests and guidance for alarm systems in medical

electrical equipment and medical electrical systems ................................................ 50

Annexes ............................................................................................................................... 51

Annex AA (informative) Particular guidance and rationale .................................................... 52

Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL

EQUIPMENT ............................................................................................................................ 78

Bibliography .......................................................................................................................... 87

Index of defined terms used in this particular standard .......................................................... 89

Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT ........................... 16

Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT ....................................... 16

Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 ................................ 22

Figure 201.104 – Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT

CIRCUITS and load between electrodes .................................................................................. 25

Figure 201.105 – Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT

CIRCUITS and a load resistance from ACTIVE ELECTRODE to earth ............................................ 26

Figure 201.106 – Measurement of HF LEAKAGE CURRENT for HF ISOLATED PATIENT

CIRCUITS ................................................................................................................................ 27

Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ACCESSORY .............. 28

Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY ................... 34

Figure 201.109 – Measurement of output power – MONOPOLAR output ................................... 39

Figure 201.110 – Measurement of output power – BIPOLAR output ......................................... 40

---------------------- Page: 8 ----------------------
SIST EN IEC 60601-2-2:2018
IEC 60601-2-2:2017  IEC 2017 – 3 –
Figure 201.111 – Method of testing feedback from one active output to another in

simultaneous activation ......................................................................................................... 43

Figure AA.1 – Examples of various parts of an HF surgical ME SYSTEM ................................... 54

Figure AA.2 – Example of MONOPOLAR method of HF surgery using a NEUTRAL

ELECTRODE ............................................................................................................................ 54

Figure AA.3 – Example of BIPOLAR method of HF surgery ...................................................... 55

Figure AA.4 – CREST FACTOR vs. peak voltage ...................................................................... 60

Figure AA.5 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth

at operating frequencies ....................................................................................................... 64

Figure BB.1 – E-FIELD EMISSIONS test setup ........................................................................... 81

Figure BB.2 – H-FIELD EMISSIONS test setup .......................................................................... 82

Figure BB.3 – Conducted EMISSIONS test setup ..................................................................... 83

Figure BB.4 – Unit ad hoc test .............................................................................................. 85

Figure BB.5 – Power cord ad hoc test ................................................................................... 86

Figure BB.6 – ACCESSORY cord ad hoc test ........................................................................... 86

Table 201.101 – Colours of indicator lights and their meaning for HF SURGICAL

EQUIPMENT ............................................................................................................................ 16

Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS .................................. 42

Table 201.103 – Test currents by weight range ..................................................................... 46

Table AA.1 – Summary of measured current and durations for 25 TUR procedures ............... 73

Table AA.2 – Summary of measured currents and durations for general surgical

procedures............................................................................................................................ 74

Table BB.1 – Worst case EMISSIONS of spark gap type HF SURGICAL EQUIPMENT ..................... 84

Table BB.2 – Worst case EMISSIONS of non-spark gap (modern) HF SURGICAL EQUIPMENT ....... 84

---------------------- Page: 9 ----------------------
SIST EN IEC 60601-2-2:2018
– 4 – IEC 60601-2-2:2017  IEC 2017
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). 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. 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 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 IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any

equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-2 has been prepared by IEC subcommittee 62D:

Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical

practice.

This sixth edition cancels and replaces the fifth edition published in 2009. This edition

constitutes a technical revision. This edition includes the following significant technical

changes with respect to the previous edition:
– refinement and additions to the defined terms;

– additional separation of the requirements for HF surgical equipment and HF surgical

accessories;

– a new requirement for adult neutral electrodes to be contact quality monitoring neutral

electrodes;
– new requirements for devices that have or use a high current mode.
---------------------- Page: 10 ----------------------
SIST EN IEC 60601-2-2:2018
IEC 60601-2-2:2017  IEC 2017 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1427/FDIS 62D/1442/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.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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 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 Clause 7 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.

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.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.
---------------------- Page: 11 ----------------------
SIST EN IEC 60601-2-2:2018
– 6 – IEC 60601-2-2:2017  IEC 2017

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 12 ----------------------
SIST EN IEC 60601-2-2:2018
IEC 60601-2-2:2017  IEC 2017 – 7 –
INTRODUCTION

The minimum safety requirements specified in this particular standard are considered to

provide for a practical degree of safety in the operation of HIGH FREQUENCY SURGICAL

EQUIPMENT.

This particular standard amends and supplements IEC 60601-1:2005 and Amendment 1:2012,

Medical electrical equipment – Part 1: General requirements for basic safety and essential

performance, hereinafter referred to as the general standard (see 201.1.4).
The requirements are followed by specifications for the relevant tests.

A "Particular guidance and rationale" section giving some explanatory notes, where

appropriate, about the more important requirements is included in Annex AA.

Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an

asterisk (*).

It is considered that a knowledge of the reasons for these requirements will not only facilitate

the proper application of the standard but will, in due course, expedite any revision neces-

sitated by changes in clinical practice or as a result of developments in technology. However,

this annex does not form part of the requirements of this document.
---------------------- Page: 13 ----------------------
SIST EN IEC 60601-2-2:2018
– 8 – IEC 60601-2-2:2017  IEC 2017
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
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF

SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.

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.
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as

defined in 201.3.224 and 201.3.223.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2:2014 and IEC 60601-1-8:2006 apply as modified in Clauses 202 and 208

respectively. IEC 60601-1-3, IEC 60601-1-10 and IEC 60601-1-11 do not apply. All other

published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
______________

The general standard is IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance.
---------------------- Page: 14 ----------------------
SIST EN IEC 60601-2-2:2018
IEC 60601-2-2:2017  IEC 2017 – 9 –
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.

Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content

of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”

where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this

particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral

standard, 203.4 in this particular standard addresses the content of Clause 4 of the

IEC 60601-1-3 collateral standard, etc.). 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 or applicable

collateral 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 or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.147, additional definitions in this document are

numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and

additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are

numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this document" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 87.
Clause 2 of the general standard applies, except as follows:
Replacement:

IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral Standard: Electromagnetic disturbances –

Requirements and tests
IEC 60601-1-8:2006, Medical electrical equipment – Part 1
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.