IEC 60601-2-76:2018
(Main)Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
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 applies to the basic safety and essential performance of low energy ionized gas haemostasis 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.
This particular standard amends and supplements IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
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
L’IEC 60601-2-76:2018 s’applique à la sécurité de base et aux performances essentielles des appariels d'hémostase à gaz ionisé à faible pouvoir calorifique.
Les dangers inhérents à la fonction physiologique prévue de l'appareil EM ou des systèmes EM dans le cadre du domaine d’application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l’exception de 7.2.13 et de 8.4.1 de la norme générale.
La présente norme particulière modifie et complète l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD1:2012.
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IEC 60601-2-76
®
Edition 1.1 2023-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
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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
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 60601-2-76:2018-04+AMD1:2023-08 CSV(en-fr)
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IEC 60601-2-76
®
Edition 1.1 2023-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-7502-3
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® Registered trademark of the International Electrotechnical Commission
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---------------------- Page: 3 ----------------------
IEC 60601-2-76
®
Edition 1.1 2023-08
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
IEC 60000:2000-00+AMDX:2023-01 CSV(EN-FR)
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© IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 * General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21
201.14 Programmable electrical medical systems (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 ME SYSTEMS . 22
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 22
Annex AA (informative) Particular guidance and rationale . 23
Bibliography . 26
Index of defined terms used in this particular standard . 27
Figure 201.101 – Measurement of LEAKAGE CURRENT from the PLASMA FLARE . 12
Figure 201.102 – Measurement of low frequency PATIENT LEAKAGE CURRENT . 13
Figure 201.103 – Measurement of IONIZED GAS ACCESSORY CABLE LEAKAGE CURRENT . 14
Figure 201.104 – Test apparatus for anchorages of IONIZED GAS ACCESSORY CABLES . 19
Figure 201.105 – Measurement of temperature from the PLASMA FLARE . 20
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IEC 60601-2-76:2018+AMD1:2023 CSV – 3 –
© IEC 2023
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,
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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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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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.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-2-76 edition 1.1 contains the first edition (2018-04) [documents
62D/1554/FDIS and 62D/1573/RVD] and its amendment 1 (2023-08) [documents
62D/2047/FDIS and 62D/2076/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
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© IEC 2023
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.
This document 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 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.
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IEC 60601-2-76:2018+AMD1:2023 CSV – 5 –
© IEC 2023
The committee has decided that the contents of this document and its amendment will remain
unchanged until the stability date indicated on the IEC website under 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.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
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© IEC 2023
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.
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
29 amendment projects within the IEC 60601-1 series. Those projects were all completed and
the amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised can be found within the
IEC document 62D/1792/DC. The results and comments on the DC can be found within
62D/1808/INF. The review report for this amendment is 62D/1811A/RR.
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IEC 60601-2-76:2018+AMD1:2023 CSV – 7 –
© IEC 2023
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, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
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© IEC 2023
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 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
IEC 60601-1:2005/AMD2:2020
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IEC 60601-2-76:2018+AMD1:2023 CSV – 9 –
© IEC 2023
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 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 a
voltage or current unless stated otherwise. When a direct voltage and current is measured, the voltage or current is
4
averaged over 1 s with a sampling rate of at least 10 sample/s. When an alternating, direct or composite voltage
or current averaged over 1 s unless stated otherwise is measured, a minimum of one second is measured.
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
LEAKAGE CURRENT to 20 mA or less
ionization frequency
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© IEC 2023
201.3.208
MAXIMUM IONIZATION VOLTAGE
maximum peak voltage used to create the IONIZED GAS under NORMAL CONDITION
201.3.209
PLASMA FLARE
IONIZED GAS emitted from the IONIZED GAS ACCESSORY
visible
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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IEC 60601-2-76:2018+AMD1:2023 CSV – 11 –
© IEC 2023
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
cir
...
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
IEC 60601-2-76:2018-04(en-fr)
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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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– 2 – IEC 60601-2-76:2018 © IEC 2018
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
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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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– 4 – IEC 60601-2-76:2018 © IEC 2018
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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IEC 60601-2-76:2018 © IEC 2018 – 9 –
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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IEC 60601-2-76:2018 © IEC 2018 – 11 –
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 subclause:
201.8.7.3.101 * LEAKAGE CURRENTS
a) In order to prevent burning or neural stimulation, the LEAKAGE CURRENT from the PLASMA
FLARE shall not exceed 20 mA.
Compliance is checked as follows:
The LEAKAGE CURRENT produced by the PLASMA FLARE is measured according to
Figure 201.101. The handpiece shall be positioned to ensure the PLASMA FLARE strikes the
centre surface of the copper plate but does not close off the gas flow. The LEAKAGE
CURRENT shall be measured using an RF current meter with an accuracy of at least ± 2 % at
20 mA and a measurement range
...
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