SIST EN IEC 60601-2-76:2019/kFprA1:2023

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.

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-76:2019/oprA1:2022

---------------------- Page: 2 ----------------------
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.

---------------------- Page: 3 ----------------------
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

---------------------- Page: 4 ----------------------
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 equipment in medical practice.
25 The text of this International Standard is based on the following documents:
Draft Report on voting
62D/****/NP 62D/****/RV
26
27 Full information on the voting for the approval of this International Standard can be found in the
28 report on voting indicated in the above table.
29 The committee has decided that the contents of this document will remain unchanged until the
30 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
31 the specific document. At this date, the document will be
32 • reconfirmed,
33 • withdrawn,
34 • replaced by a revised edition, or
35 • amended.
36
37 A bilingual version
...