prEN IEC 80601-2-71:2023
(Main)Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
Medizinische elektrische Geräte - Teil 2-71: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von funktionalen Oximetriegeräten
Appareils électromédicaux - Partie 2-71: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de spectroscopie dans le proche infrarouge (NIRS) fonctionnelle
Medicinska električna oprema - 2-71. del: Posebne zahteve za osnovno varnost in bistvene lastnosti funkcionalne opreme spektrometra v bližnjem infrardečem spektru
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-71:2023
01-oktober-2023
Medicinska električna oprema - 2-71. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti funkcionalne opreme spektrometra v bližnjem infrardečem
spektru
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and
essential performance of functional near-infrared spectroscopy (NIRS) equipment
Medizinische elektrische Geräte - Teil 2-71: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von funktionalen Oximetriegeräten
Appareils électromédicaux - Partie 2-71: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de spectroscopie dans le proche
infrarouge (NIRS) fonctionnelle
Ta slovenski standard je istoveten z: prEN IEC 80601-2-71:2023
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
oSIST prEN IEC 80601-2-71:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN IEC 80601-2-71:2023
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oSIST prEN IEC 80601-2-71:2023
62D/2062/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-71 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-09-01 2023-11-24
SUPERSEDES DOCUMENTS:
62D/1924/CD, 62D/1950A/CC
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
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.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In So me Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential
performance of functional near-infrared spectroscopy (NIRS) equipment
PROPOSED STABILITY DATE: 2029
Copyright © 2023 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download
NOTE FROM TC/SC OFFICERS:
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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oSIST prEN IEC 80601-2-71:2023
62D/2026/CDV – 2 – IEC 80601-2-71:2023 © IEC 2023
ISO 80601-2-71:2023(E) (Ed 2)
62D/2062/CDV
ISO/TC 121/SC 3/ N2998
Secretariat: ANSI
2023-06-15
Medical Electrical Equipment — Part 2-71: Particular requirements for the
basic safety and essential performance of functional Near-Infrared
Spectroscopy (NIRS) equipment
Appareils électromédicaux — Partie 2-71: exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'imagerie spectroscopique proche
infrarouge (NIRS)
Draft CDV stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject
to change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent
rights of which they are aware and to provide supporting documentation.
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oSIST prEN IEC 80601-2-71:2023
IEC 80601-2-71:2023 © IEC 2023 – 3 – 62D/2062/CDV
1
2 CONTENTS
3
4 FOREWORD . 5
5 INTRODUCTION . 7
6 201.1 Scope, object and related standards . 8
7
...
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