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SIST EN 60601-2-64:2015/oprA1:2024

(Amendment)

Amendment 1 - Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

Amendment 1 - Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Leichtionen-Bestrahlungseinrichtungen

Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base et les performances essentielles des appareils électromédicaux par faisceau d'ions légers

Medicinska električna oprema - 2-64. del: Posebne zahteve za osnovno varnost in bistvene lastnosti medicinske opreme za lahkoionsko terapijo - Dopolnilo A1

General Information

Status
Not Published
Public Enquiry End Date
30-Apr-2024
ICS
11.040.60 - Therapy equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
14-Feb-2024
Due Date
03-Jul-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
EN 60601-2-64:2015/prA1:2024 - Amendment 1 - Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

Relations

Amends
SIST EN 60601-2-64:2015 - Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical equipment
Effective Date
23-Jan-2023

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SLOVENSKI STANDARD
SIST EN 60601-2-64:2015/oprA1:2024
01-april-2024
Medicinska električna oprema - 2-64. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinske opreme za lahkoionsko terapijo - Dopolnilo A1
Amendment 1 - Medical electrical equipment - Part 2-64: Particular requirements for the
basic safety and essential performance of light ion beam medical electrical equipment
Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Leichtionen-
Bestrahlungseinrichtungen
Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils électromédicaux par faisceau d'ions
légers
Ta slovenski standard je istoveten z: EN 60601-2-64:2015/prA1:2024
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-64:2015/oprA1:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-64:2015/oprA1:2024

---------------------- Page: 2 ----------------------
SIST EN 60601-2-64:2015/oprA1:2024
62C/905/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-64/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-02-09 2024-05-03
SUPERSEDES DOCUMENTS:
62C/878/CD, 62C/890A/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:


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:
Amendment 1 - Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and
essential performance of light ion beam medical electrical equipment

PROPOSED STABILITY DATE: 2024

NOTE FROM TC/SC OFFICERS:
In the attached CDV, red characters represent changes from Ed1 to AMD1/CD1, blue characters represent
changes from AMD1/CD1 to AMD1/CD2, purple characters represent changes from AMD1/CD2 to AMD1/CDV,
respectively, based on the NCs' comments and discussion in WG 1.
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 permis sion
in writing from IEC.

---------------------- Page: 3 ----------------------
SIST EN 60601-2-64:2015/oprA1:2024
62C/905/CDV – 2 – IEC 60601-2-64/A1 CDV © IEC 2024

As indicated in 62C/766/Q, the scope of AMD1 is as follows:
1) Harmonization with IEC 60601-1 Ed1/AMD2
2) Harmonization with IEC 62667 (light ion performance) for defined terms
3) Neutrons outside the field of irradiation.
In addition, a correction to the current edition has been prepared for CDV, while any other comments, such as the
introduction of a new concept, are excluded and are expected to be discussed in a future amendment or edition.

---------------------- Page: 4 ----------------------
SIST EN 60601-2-64:2015/oprA1:2024
IEC 60601-2-64/A1 CDV © IEC 2024 – 3 –  62C/905/CDV
1 CONTENTS
2 CONTENTS . 1
3 FOREWORD . 4
4 INTRODUCTION . 6
5 201.1 Scope, object and related standards . 7
6 201.2 Normative re
...

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