EN IEC 60601-2-76:2019

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

• Status: Published
• Publication Date: 23-May-2019
• Withdrawal Date: 23-May-2022
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-May-2019
• Completion Date: 24-May-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN IEC 60601-2-76:2019 - 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)

Relations

• Amended By: EN IEC 60601-2-76:2019/A1:2023 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
• Effective Date: 26-Jul-2021

Standards Content (Sample)

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)

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