prEN IEC 60601-2-37:2023
(Main)Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
Medicinska električna oprema - 2-37. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ultrazvočne medicinske diagnostične in nadzorovalne opreme
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-37:2023
01-september-2023
Medicinska električna oprema - 2-37. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ultrazvočne medicinske diagnostične in nadzorovalne opreme
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die
medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de diagnostic et de surveillance médicaux
à ultrasons
Ta slovenski standard je istoveten z: prEN IEC 60601-2-37:2023
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
oSIST prEN IEC 60601-2-37:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN IEC 60601-2-37:2023
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oSIST prEN IEC 60601-2-37:2023
62B/1318/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-37 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-06-16 2023-09-08
SUPERSEDES DOCUMENTS:
62B/1295/CD, 62B/1304A/CC
IEC SC 62B : MEDICAL IMAGING EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
TC 87
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 Some Countries” clau ses
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 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment
PROPOSED STABILITY DATE: 2026
Copyright © 2023 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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oSIST prEN IEC 60601-2-37:2023
62B/1318/CDV – 2 – CDV IEC 60601-2-37 © IEC 2023
NOTE FROM TC/SC OFFICERS:
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oSIST prEN IEC 60601-2-37:2023
62B/1318/CDV – 3 – CDV IEC 60601-2-37 © IEC 2023
1 CONTENTS
2 CONTENTS . 1
3 FOREWORD . 4
4 INTRODUCTION . 6
5 INTRODUCTION TO AMENDMENT 1 . 6
6 INTRODUCTION TO EDITION 3 . 6
7 201.1Scope, object and related standards . 7
8 201.2Normative references . 8
9 201.3Terms and definitions . 9
10 201.4General requirements . 15
11 201.5General requirements for testing ME EQUIPMENT .
...
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