EN IEC 60601-2-76:2019
(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.
Medizinische elektrische Geräte - Teil 2-76: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Koagulation mittels ionisierten Gasen
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.
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)
Standard IEC 60601-2-76:2018 se uporablja za osnovno varnost in bistvene lastnosti opreme za hemostazijo z nizkoenergijskim ioniziranim plinom. Posebne zahteve tega dokumenta ne vključujejo temeljnih tveganj pri nameravani fiziološki funkciji elektromedicinske opreme in sistemov, ki spadajo na področje uporabe tega dokumenta, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda. Ta standard dopolnjuje in izpopolnjuje standarda IEC 60601-1:2005 in IEC 60601-1:2005/AMD1:2012.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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)
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
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
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,
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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
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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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.
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 r
...
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