SIST EN 60601-2-45:2011/oprA2:2022

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

• Status: Not Published
• Public Enquiry End Date: 31-Mar-2022
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 20-Jan-2022
• Due Date: 09-Jun-2022
• Completion Date: 26-Oct-2022
• 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
• Directive: 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
• Mandate: 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 60601-2-45:2011/prA2:2022 - 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

Relations

• Amends: SIST EN 60601-2-45:2011 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2011)
• Effective Date: 09-Dec-2021

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.

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SIST EN 60601-2-45:2011/oprA2:2022

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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.

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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

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35 FOREWORD
36 Replace, in the second paragraph, the reference to
37 IEC 60601-1-3 (2010)
38 by
39 IEC 60601-1-3 (2021)
40 201.1 Scope, object and related standards
41 Replace, in footnote 1, the reference to
42 IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012
43 by
44 IEC 60601-1
45 201.1.3 Collateral standards
46 Replace the first sentence of the second paragraph by
47 IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203, respectively.
48 Replace the second sentence of the second paragraph, including its footnote, by
49 IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not
2)
50 apply .
51
___________
2)
IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for environmentally conscious design. IEC 60601-1-10,
Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic closed-loop controllers. IEC 60601-1-11,
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the
home healthcare environment. IEC 60601-1-12, Medical electrical equipment – Part 1-12: General
requirements for basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the emergency medical services environment.

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52 201.2 Normative references
53 Add the following new reference after the text “Clause 2 of the general standard applies, except
54 as follows:”
55 Addition:
56 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
57 and essential performance
58 IEC 60601-1:2005/AMD1:2012
59 IEC 60601-1:2005/AMD2:2020
60 Replace the existing references to IEC 60601-1-2:2014 by
61 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
62 safety and essential performance – Collateral standard: Electromagnetic compatibility –
63 Requirements and tests
64 IEC 60601-1-2:2014/AMD1:2020
65 Replace the existing references to IEC 60601-1-3:2008 by
66 IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
67 safety and essential performance – Collateral standard: Radiation protection in diagnostic X-
68 ray equipment
69 IEC 60601-1-3:2008/AMD1:2013
70 IEC 60601-1-3:2008/AMD2:2021
71 Add the following reference after “Addition”:
72 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
73 and essential performance
74 IEC 60601-1:2005/AMD1:2012
75 IEC 60601-1:2005/AMD2:2020
76 Replace the existing reference
77 IEC 60788:2004
78 by
79 IEC TR 60788:2004
80 201.3 Terms and definitions
81 Replace in this subclause the first paragraph by
82 For the purposes of this document, the terms and definitions given in IEC 60601-1, IEC 60601-
83 1-3 and IEC TR 60788 apply, except as follows:
84 201.4.3 Essential performance
85 Replace the headline of the following subclause by
86 201.4.3.101 *Additional potential ESSENTIAL PERFORMANCE requirements
87 Replace in this subclause the first paragraph by

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