SIST 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 (IEC 60601-2-76:2018/AMD1:2023)

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/AMD1:2023)

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/AMD1:2023)

Medicinska električna oprema - 2-76. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za hemostazijo z nizkoenergijskim ioniziranim plinom - Dopolnilo A1 (IEC 60601-2-76:2018/AMD1:2023)

General Information

• Status: Published
• Public Enquiry End Date: 31-Jul-2022
• Publication Date: 17-Oct-2023
• ICS: 11.040 - Medical equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-Oct-2023
• Due Date: 18-Dec-2023
• Completion Date: 18-Oct-2023
• Ref Project: 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

Relations

• Amends: 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)
• Effective Date: 26-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-76:2019/A1:2023
01-december-2023
Medicinska električna oprema - 2-76. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za hemostazijo z nizkoenergijskim ioniziranim plinom -
Dopolnilo A1 (IEC 60601-2-76:2018/AMD1:2023)
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/AMD1:2023)
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/AMD1:2023)
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/AMD1:2023)
Ta slovenski standard je istoveten z: EN IEC 60601-2-76:2019/A1:2023
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN IEC 60601-2-76:2019/A1:2023 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/A1:2023

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SIST EN IEC 60601-2-76:2019/A1:2023


EUROPEAN STANDARD EN IEC 60601-2-76:2019/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM October 2023
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/AMD1:2023)
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 Niedrigenergie-
pouvoir calorifique Ionengas-Hämostasegeräten
(IEC 60601-2-76:2018/AMD1:2023) (IEC 60601-2-76:2018/AMD1:2023)
This amendment A1 modifies the European Standard EN IEC 60601-2-76:2019; it was approved by CENELEC on 2023-10-05. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye 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
© 2023 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/A1:2023 E

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SIST EN IEC 60601-2-76:2019/A1:2023
EN IEC 60601-2-76:2019/A1:2023 (E)
European foreword
The text of document 62D/2047/FDIS, future IEC 60601-2-76/AMD1, 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/A1:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-07-05
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-10-05
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-76:2018/AMD1:2023 was approved
...

SLOVENSKI STANDARD
SIST EN IEC 60601-2-76:2019/oprA1:2022
01-julij-2022
Medicinska električna oprema - 2-76. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za hemostazijo z nizkoenergijskim ioniziranim plinom -
Dopolnilo A1
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and
essential performance of low energy ionized gas haemostasis equipment
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
Ta slovenski standard je istoveten z: EN IEC 60601-2-76:2019/prA1:2022
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN IEC 60601-2- en
76:2019/oprA1:2022
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/oprA1:2022

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SIST EN IEC 60601-2-76:2019/oprA1:2022
62D/1952/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-76/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-05-20 2022-08-12
SUPERSEDES DOCUMENTS:
62D/1811A/RR

IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:


Other TC/SCs are requested to indicate their interest, if any, in this
CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.

TITLE:
Amendment 1 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and
essential performance of low energy ionized gas haemostasis equipment

PROPOSED STABILITY DATE: 2027

NOTE FROM TC/SC OFFICERS:
IEC 60601-2-76 ED1 is being amended to be in alignment with the IEC 60601-1 series amendment projects. Refer
to 62D/1792/DC and 62D/1808/INF documents for the project maintenance decision.
Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

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SIST EN IEC 60601-2-76:2019/oprA1:2022
62D/1952/CDV                       – 2 – IEC 60601-2-76:2018 AMD1 © IEC:2022
1 CONTENTS
2 FORWORD ………………………………………………………………………………………………… 3
3 INTRODUCTION . 4
4 201.1 Scope, object and related standards . 5
5 201.1.4 Particular standards . 5
6 201.2Normative references . 5
7 201.3Terms and definitions . 5
8 Index of defined terms used in this particular standard . 6
9
10
11

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SIST EN IEC 60601-2-76:2019/oprA1:2022
IEC 60601-2-76:2018 AMD1 © IEC:2022 – 3 –                        62D/1952/CDV
12 INTERNATIONAL ELECTROTECHNICAL COMMISSION
13 ____________
14
15 MEDICAL ELECTRICAL EQUIPMENT –
16
17 Part 2-76: Particular requirements for the basic safety and essential
18 performance of low energy ionized gas haemostasis equipment
19
20 AMENDMENT 1
21
22 FOREWORD
23 This Amendment has been prepared by IEC subcommittee 62D: Electromedical equipment, of
24 IEC technical committee 62: Electrical e
...