Amendment 1 - Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

Amendement 1 - Appareils électromédicaux - Partie 2-68: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de radiothérapie à rayonnement X assistée par imagerie médicale, destinés à être utilisés avec les accélérateurs d'électrons, les appareils de thérapie par faisceau d'ions légers et les appareils de thérapie par faisceau de radionucléides

Medicinska električna oprema - 2-68. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih naprav pri slikovno vodeni radioterapiji z elektronskimi pospeševalniki, napravami za lahkoionsko radioterapijo in napravami za radionuklidno radioterapijo - Dopolnilo A1

General Information

Status
Not Published
Public Enquiry End Date
26-Oct-2023
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
09-Aug-2023
Due Date
27-Dec-2023

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SLOVENSKI STANDARD
SIST EN 60601-2-68:2015/oprA1:2023
01-oktober-2023
Medicinska električna oprema - 2-68. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenskih naprav pri slikovno vodeni radioterapiji z
elektronskimi pospeševalniki, napravami za lahkoionsko radioterapijo in
napravami za radionuklidno radioterapijo - Dopolnilo A1
Amendment 1 - Medical electrical equipment - Part 2-68: Particular requirements for the
basic safety and essential performance of X-ray-based image-guided radiotherapy
equipment for use with electron accelerators, light ion beam therapy equipment and
radionuclide beam therapy equipment
Amendement 1 - Appareils électromédicaux - Partie 2-68: Exigences particulières pour la
sécurité de base et les performances essentielles des appareils de radiothérapie à
rayonnement X assistée par imagerie médicale, destinés à être utilisés avec les
accélérateurs d'électrons, les appareils de thérapie par faisceau d'ions légers et les
appareils de thérapie par faisceau de radionucléides
Ta slovenski standard je istoveten z: EN 60601-2-68:2015/prA1:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-68:2015/oprA1:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-68:2015/oprA1:2023

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SIST EN 60601-2-68:2015/oprA1:2023
62C/876/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-68/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-08-04 2023-10-27
SUPERSEDES DOCUMENTS:
62C/774/CD, 62C/834A/CC

IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

SC 62B
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:
Amendment 1 - Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and
essential performance of X-ray-based image-guided radiotherapy equipment for use with electron
accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

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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SIST EN 60601-2-68:2015/oprA1:2023
62C/876/CDV – 2 – IEC CDV 60601-2-68:2014/AMD 1 © IEC 2023
PROPOSED STABILITY DATE: 2029

NOTE FROM TC/SC OFFICERS:
For supporting information please see 62C/877/INF, which contains IEC 60601-2-68:2014 with the changes proposed
by this CDV, visibly incorporated.

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SIST EN 60601-2-68:2015/oprA1:2023
IEC CDV 60601-2-68:2014/AMD 1 © IEC 2023 – 3 – 62C/876/CDV
1 CONTENTS
2
3 FOREWORD . 5
4 INTRODUCTION to Amendment 1 . 7
5 INTRODUCTION . 8
6 201.1 Scope, object and related standards . 10
7 201.2 Normative references . 10
8 201.3
...

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