SIST EN IEC 60601-2-76:2019

SLOVENSKI STANDARD
SIST EN IEC 60601-2-76:2019
01-september-2019
Medicinska električna oprema - 2-76. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za hemostazijo z nizkoenergijskim ioniziranim plinom
(IEC 60601-2-76:2018)
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and
essential performance of low energy ionized gas haemostasis equipment (IEC 60601-2-
76:2018)
Medizinische elektrische Geräte - Teil 2-76: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Koagulation mittels
ionisierten Gasen (IEC 60601-2-76:2018)
Appareils électromédicaux - Partie 2-76: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d’hémostase à gaz ionisé à faible pouvoir
calorifique (IEC 60601-2-76:2018)
Ta slovenski standard je istoveten z: EN IEC 60601-2-76:2019
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN IEC 60601-2-76:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-76:2019

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SIST EN IEC 60601-2-76:2019


EUROPEAN STANDARD EN IEC 60601-2-76

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2019
ICS 11.040

English Version
Medical electrical equipment - Part 2-76: Particular requirements
for the basic safety and essential performance of low energy
ionized gas haemostasis equipment
(IEC 60601-2-76:2018)
Appareils électromédicaux - Partie 2-76: Exigences Medizinische elektrische Geräte - Teil 2-76: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils d'hémostase à gaz ionisé à faible wesentlichen Leistungsmerkmale von Geräten zur
pouvoir calorifique Koagulation mittels ionisierten Gasen
(IEC 60601-2-76:2018) (IEC 60601-2-76:2018)
This European Standard was approved by CENELEC on 2018-05-15. 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60601-2-76:2019 E

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SIST EN IEC 60601-2-76:2019
EN IEC 60601-2-76:2019 (E)
European foreword
The text of document 62D/1554/FDIS, future edition 1 of IEC 60601-2-76, 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 60601-2-76:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2019-11-24
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-05-24
document have to be withdrawn

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 60601-2-76:2018 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 60601-2-2:2017 NOTE Harmonized as EN IEC 60601-2-2:2018 (not modified)

2

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SIST EN IEC 60601-2-76:2019
EN IEC 60601-2-76:2019 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1  Where 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

Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014

3

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SIST EN IEC 60601-2-76:2019



IEC 60601-2-76

®


Edition 1.0 2018-04




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Medical electrical equipment –

Part 2-76: Particular requirements for the basic safety and essential performance

of low energy ionized gas haemostasis equipment




Appareils électromédicaux –

Partie 2-76: Exigences particulières pour la sécurité de base et les performances


essentielles des appareils d’hémostase à gaz ionisé à faible pouvoir calorifique













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.040 ISBN 978-2-8322-5497-4



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

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CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 * General requirements . 9
201.5 General requirements for testing ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents . 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 10
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 19
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 20
201.14 Programmable electrical medical systems (PEMS) . 20
201.15 Construction of ME EQUIPMENT . 20
201.16 ME SYSTEMS . 21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
Annex AA (informative) Particular guidance and rationale . 22
Bibliography . 25
Index of defined terms used in this particular standard . 26

Figure 201.101 – Measurement of LEAKAGE CURRENT from the PLASMA FLARE . 11
Figure 201.102 – Measurement of low frequency PATIENT LEAKAGE CURRENT . 12
Figure 201.103 – Measurement of IONIZED GAS ACCESSORY CABLE LEAKAGE CURRENT . 13
Figure 201.104 – Test apparatus for anchorages of IONIZED GAS ACCESSORY CABLES . 18
Figure 201.105 – Measurement of temperature from the PLASMA FLARE . 19

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IEC 60601-2-76:2018 © IEC 2018 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-76: Particular requirements for the basic safety and essential
performance of low energy ionized gas haemostasis equipment

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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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 60601-2-76 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1554/FDIS 62D/1573/RVD

Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

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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 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.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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IEC 60601-2-76:2018 © IEC 2018 – 5 –
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of LOW ENERGY IONIZED GAS
HAEMOSTASIS EQUIPMENT.
This particular standard amends and supplements IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 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 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
necessitated 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.

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MEDICAL ELECTRICAL EQUIPMENT –

Part 2-76: Particular requirements for the basic safety and essential
performance of low energy ionized gas haemostasis equipment



201.1 Scope, object and related standards
1
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 LOW
ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT hereafter referred to as ME EQUIPMENT.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
201.1.2 Object
Replacement:
BASIC SAFETY
The object of this particular standard is to establish particular requirements for
and ESSENTIAL PERFORMANCE of LOW ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT as defined in
201.3.207.
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.
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.
A requirement of a particular standard takes priority over the general standard.
___________
1
 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.

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IEC 60601-2-76:2018 © IEC 2018 – 7 –
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this
particular standard as the general standard. Collateral standards are referred to by their
document numbers.
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 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 because 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 6060-1-3, 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.
Clause 2 of the general standard applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012

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201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
Replacement of NOTE 1 by the following:
NOTE 1 Where the terms “voltage” and “current” are used in this document, they mean the RMS values of an
alternating, direct or composite voltage or current averaged over 1 s unless stated otherwise.
Addition:
201.3.201
FINGERSWITCH
device generally included with an IONIZED GAS ACCESSORY which, when activated by the
OPERATOR, enables IONIZED GAS output to be produced and, when released, disables the
IONIZED GAS output
201.3.202
* HAEMOSTASIS
control or prevention of bleeding from capillaries and similar small blood vessels in biological
tissues using IONIZED GAS
201.3.203
IONIZED GAS
gas composed in part of charged particles and excited atoms or molecules
Note 1 to entry: The frequency used to create the IONIZED GAS is called the ionization frequency.
201.3.204
IONIZED GAS ACCESSORY
ACCESSORY intended to direct IONIZED GAS to the PATIENT
201.3.205
IONIZED GAS ACCESSORY CABLE
portion of the IONIZED GAS ACCESSORY between the IONIZED GAS CONNECTOR and the part held
by the OPERATOR
201.3.206
IONIZED GAS CONNECTOR
part of a IONIZED GAS ACCESSORY intended for connection to the output TERMINAL DEVICE of LOW
ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT
201.3.207
* LOW ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT
ME EQUIPMENT including an IONIZED GAS ACCESSORY and any other associated ACCESSORIES
which uses IONIZED GAS for the purpose of HAEMOSTASIS in biological tissue and limits the
ionization frequency LEAKAGE CURRENT to 20 mA or less
201.3.208
MAXIMUM IONIZATION VOLTAGE
maximum peak voltage used to create the IONIZED GAS under NORMAL CONDITION

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201.3.209
PLASMA FLARE
visible IONIZED GAS emitted from the IONIZED GAS ACCESSORY
201.4 * General requirements
Clause 4 of the general standard applies.
NOTE See Annex AA for additional information.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.9.2.1 * General
Replace the third dashed item by the following dashed items:
– advice for the OPERATOR to avoid LOW ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT output
settings that may exceed the rating(s) of the IONIZED GAS ACCESSORY;
– any known contraindication(s) to the use of the ME EQUIPMENT. For LOW ENERGY IONIZED GAS
HAEMOSTASIS EQUIPMENT this shall include, at minimum, a statement that the equipment is
not intended for use where blood flow is at arterial pressure; and
Additional subclause:
201.7.9.2.2.101 Additional warnings
The instructions for use shall include the following warnings:
1) the IONIZED GAS ACCESSORY CABLE should be positioned in such a way that contact with the
PATIENT or other leads is avoided;
2) for PATIENTS with cardiac pacemakers or other active implants, a possible HAZARD exists
because interference with the action of the pacemaker may occur, or the pacemaker may
be damaged. In case of doubt, approved qualified advice should be obtained.
201.7.9.2.14 ACCESSORIES, supplementary equipment, used material
Addition:
The instructions for use shall include:
Advice for the OPERATOR to avoid using the IONIZED GAS ACCESSORY with LOW ENERGY IONIZED
GAS HAEMOSTASIS EQUIPMENT output settings that may exceed the rating(s) of the ACCESSORY.

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201.7.9.3 Technical description
201.7.9.3.1 General
Addition:
– Voltage output data. The MAXIMUM IONIZATION VOLTAGE.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.3 * Classification of APPLIED PARTS
Addition:
aa) IONIZED GAS ACCESSORIES shall be considered APPLIED PARTS, and shall be TYPE BF or TYPE
CF because the PLASMA FLARE provides a conductive path between the IONIZED GAS
ACCESSORY and the PATIENT.
Additional subclause:
201.8.4.101 Excitation current monitoring circuits
Circuits monitoring the flow of current used to generate the IONIZED GAS shall be isolated from
earth by at least two MEANS OF PATIENT PROTECTION.
201.8.5.1.2 * MEANS OF PATIENT PROTECTION (MOPP)
Amendment:
IONIZED GAS ACCESSORIES including IONIZED GAS ACCESSORY CABLES and IONIZED GAS
For
CONNECTORS, separation between the circuits used to generate the IONIZED GAS and the
ENCLOSURE including SIGNAL INPUT PARTS and SIGNAL OUTPUT PARTS need not be subjected to
the dielectric strength test of 201.8.8.3.
The CREEPAGE DISTANCES and AIR CLEARANCES of the equipment other than IONIZED GAS
ACCESSORIES tested according to 201.8.8.3.101 and that are intended to prevent contact with
circuits used to generate the IONIZED GAS shall be as follows:
a) For an ionization frequency less than 1 kHz, the general standard applies.
b) For an ionization frequency between 1 kHz and 200 kHz, the greater value of the following
calculation is chosen:
13 f 17,3 f
CREEPAGE DISTANCE:
16− mm/kV, or 21− mm
200 200
6,14 f 8,2 f
AIR CLEARANCE:
mm/kV, or mm
9,14− 12,2−
200 200

where
f is the frequency in kHz.
c) For an ionization frequency higher than 200 kHz, the CREEPAGE DISTANCE and AIR
CLEARANCE is at least 3 mm/kV or 4 mm, whichever is the greater.
The reference voltage shall be the maximum peak voltage.

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This requirement does not apply for components when the adequacy of ratings can be
demonstrated, for example by component manufacturers’ ratings or by the dielectric strength
test of 201.8.8.3.
This requirement described in 201.8.5.1.2 does not apply to IONIZED GAS ACCESSORIES. On the
other hand, the requirements and tests for IONIZED GAS ACCESSORIES are found in 201.8.8.3.
201.8.7.3 Allowable values
Amendment:
Item e) does not apply
Additional subc
...