EN 60601-2-45:2011/prA2:2022
(Amendment)Amendment 2 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Amendment 2 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgen-Mammographiegeräten und mammographischen Stereotaxie-Einrichtungen
Appareils électromédicaux - Partie 2-45: Exigences particulières pour la sécurite de base et les performances essentielles des appareils de mammographie à rayonnement X et des appareils mammographiques steréotaxiques
Medicinska električna oprema - 2-45. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za mamografijo in stereotaktičnih naprav za mamografijo - Dopolnilo A2
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-45:2011/oprA2:2022
01-marec-2022
Medicinska električna oprema - 2-45. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za mamografijo in stereotaktičnih naprav za
mamografijo - Dopolnilo A2
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and
essential performance of mammographic X-ray equipment and mammographic
stereotactic devices
Appareils électromédicaux - Partie 2-45: Exigences particulières pour la sécurite de base
et les performances essentielles des appareils de mammographie à rayonnement X et
des appareils mammographiques steréotaxiques
Ta slovenski standard je istoveten z: EN 60601-2-45:2011/prA2:2022
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-45:2011/oprA2:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 60601-2-45:2011/oprA2:2022
---------------------- Page: 2 ----------------------
SIST EN 60601-2-45:2011/oprA2:2022
62B/1271/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-45/AMD2 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-01-14 2022-04-08
SUPERSEDES DOCUMENTS:
IEC SC 62B : DIAGNOSTIC IMAGING EQUIPMENT
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
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 2 - Medical electrical equipment - Part 2-45: Particular requirements for the basic
safety and essential performance of mammographic X-ray equipment and mammographic
stereotactic devices
PROPOSED STABILITY DATE: 2025
NOTE FROM TC/SC OFFICERS:
1
Copyright © 2021 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 60601-2-45:2011/oprA2:2022
62B/1271/CDV – 2 – IEC CDV 60601-2-45/A1 © IEC 2021
2 FOREWORD
3 This amendment has been prepared by subcommittee 62B: DIAGNOSTIC IMAGING
4 EQUIPMENT, of IEC technical committee 62: ELECTRICAL EQUIPMENT IN MEDICAL
5 PRACTICE.
6 The text of this amendment is based on the following documents:
FDIS Report on voting
62B/xxx/FDIS 62B/xxx/RVD
7
8 Full information on the voting for the approval of this amendment can be found in the report on
9 voting indicated in the above table.
10 The committee has decided that the contents of this amendment and the base publication will
11 remain unchanged until the stability date indicated on the IEC web site under
12 "http://webstore.iec.ch" in the data related to the specific publication. At this date , the
13 publication will be
14 • reconfirmed,
15 • withdrawn,
16 • replaced by a revised edition, or
17 • amended.
18 NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing
19 organizations may need a transitional period following publication of a new, amended or revised IEC publication in
20 which to make products in accordance with the new requirements and to equip themselves for conducting new or
21 revised tests. It is the recommendation of the committee that the content of this publicat ion be adopted for
22 implementation nationally not earlier than 3 years from the date of publication.
23
24 _____________
25
26 INTRODUCTION TO THE AMENDMENT 2
27 This second amendment to the third edition of this particular standard has been prepared to
28 provide a complete set of safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on
29 the second amendment (2020) to IEC 60601-1:2005 and associated collateral standards.
30 Moreover, in annex AA the description of the term for ESSENTIAL PERFORMANCE is modified to
31 better reflect the clarification published as interpretation sheet 1 of IEC 60601-1:2005/
32 AMD1:2012. This particular standard addresses the system level of MAMMOGRAPHIC X-RAY
33 EQUIPMENT including the equipment for MAMMOGRAPHIC TOMOSYNTHESIS.
34
---------------------- Page: 4 ------
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.