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 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.

General Information

• Status: Published
• Publication Date: 30-Aug-2023
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040 - Medical equipment
• ICS: 47.020.60 - Electrical equipment of ships and of marine structures
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 34 - TC 62/SC 62D/MT 34
• Current Stage: PPUB - Publication issued
• Start Date: 13-Apr-2018
• Completion Date: 10-Apr-2018

Relations

• Amended By: IEC 60601-2-76:2018/AMD1:2023 - Amendment 1 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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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

– 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

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-
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consensus of opinion on the relevant subjects since each technical committee has representation from all
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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.

– 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 a
...

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et
les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
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les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

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The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
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A propos des publications IEC
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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

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)

– 2 – IEC 60601-2-76:2018+AMD1:2023 CSV
© 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

© 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,
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.
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.
– 4 – IEC 60601-2-76:2018+AMD1:2023 CSV
© 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 o
...