SIST EN IEC 80601-2-49:2019/oprA1:2023

SLOVENSKI STANDARD
SIST EN IEC 80601-2-49:2019/oprA1:2023
01-januar-2023
Medicinska električna oprema - 2-49. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti večfunkcijske opreme za nadzor pacientov - Dopolnilo A1
Amendment 1 - Medical electrical equipment - Part 2-49: Particular requirements for the
basic safety and essential performance of multifunction patient monitors
Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base
et les performances essentielles des moniteurs multifonctions des patients
Ta slovenski standard je istoveten z: EN IEC 80601-2-49:2019/prA1:2022
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 80601-2- en
49:2019/oprA1:2023
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 80601-2-49:2019/oprA1:2023

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SIST EN IEC 80601-2-49:2019/oprA1:2023
62D/1991/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-49/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-11 2023-02-03
SUPERSEDES DOCUMENTS:
62D/1894/CD, 62D/1923A/CC

IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
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.

TITLE:
Amendment 1 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety
and essential performance of multifunction patient monitors

PROPOSED STABILITY DATE: 2028

NOTE FROM TC/SC OFFICERS:

Copyright © 2022 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 IEC 80601-2-49:2019/oprA1:2023
62D/1991/CDV – 2 – IEC/CD 80601-2-49:2018/AMD1:2022
1 FOREWORD
2
3 This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
4 technical committee 62: Electrical equipment in medical practice.
5 The text of this amendment is based on the following documents:
Draft Report on voting
XX/XX/FDIS XX/XX/RVD
6
7 Full information on the voting for its approval can be found in the report on voting indicated in
8 the above table.
9 The committee has decided that the contents of this document will remain unchanged until the
10 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
11 the specific document. At this date, the document will be
12 • reconfirmed,
13 • withdrawn,
14 • replaced by a revised edition, or
15 • amended.
16
17 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
18 organizations may need a transitional period following publication of a new, amended or revised IEC or
19 ISO publication in which to make products in accordance with the new requirements and to equip themselves for
20 conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
21 adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.
22
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.
23
24 _____________
25
26 INTRODUCTION to Amendment 1
27 At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
28 the need for administrative/technical changes to most 62D standards after completion of the
29 amendment projects within the IEC 60601-1 series. Those projects were all completed and the
30 amendments published in 2020.
31 The full list of IEC SC 62D documents that will be amended or revised may be found within the
32 IEC document 62D/1792/DC. The results and comments on the DC may be found within
33 62D1808/INF. The review report for this amendment is 62D/1835A/RR.
34 _____________
35

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SIST EN IEC 80601-2-49:2019/oprA1:2023
IEC CD 80601-2-49:2018/AMD1:2021 – 3 – 62D/1894/CDV
36
37 Replace the text in footnote 1 with:
38
39 “The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
40 2:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic
41 safety and essential performance”.
42
43 201.1.3 Collateral standards
44 Replace the second paragraph with:
45 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-
46 6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, as well as IEC 60601-1-8:2006,
47 IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020 apply as modified in
48 Clauses 202, 206 and 208 respectively. IEC 60601-1-3 and IEC 60601-1-9 do not apply. All
49 other published collateral standards in the IEC 60601-1 series apply as published.
50
51 4 Particular standards
52 Replace third paragraph with:
53 For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
54 IEC 60601-1:2005/AMD2:2020 are referred to in this particular standard as the general
55 standard. Collateral standards are referred to by their document number.
th
56 In the second sentence of the 8 paragraph replace “ 3.1 through 3.147” with “3.1 through 1.54”
57  Normative references
58 Replace existing text with:
59 NOTE Informative references are listed in the Bibliography beginning on page 38.
60 Clause 2 of the general standard applies, except as follows.
61 Replacement:
62 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
63 safety and essential performance – Collateral Standard: Electromagnetic disturbances –
64 Requirements and tests
65 IEC 60601-1-2:2014/AMD1:2020
66 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
67 safety and essential performance – Collateral standard: Usability
68 IEC 60601-1-6:2010/AMD1:2013
69 IEC 60601-1-6:2010/AMD2:2020
70 IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
71 safety and essential performance – Collateral standard: General requirements, tests and
72 guidance for alarm systems in medical electrical equipment and medical electrical systems
73 IEC 60601-1-8:2006/AMD1:2012
74 IEC 60601-1-8:2006/AMD2:2020

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SIST EN IEC 80601-2-49:2019/oprA1:2023
62D/1991/CDV – 4 – IEC/CD 80601-2-49:2018/AMD1:2022
75 Addition:
76 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
77 and essential performance
78 IEC 60601-1:2005/AMD1:2012
79 IEC 60601-1:2005/AMD2:2020
80 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
81 safety and essential performance – Collateral Standard: Requirements for medical electrical
82 equipment and medical electrical systems used in the home healthcare environment
83 IEC 60601-1-11:2015/AMD1:2020
84 IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic
85 safety and essential performance – Collateral Standard: Requirements for medical electrical
86 equipment and medical electrical systems intended for use in the emergency medical services
87 environment
88 IEC 60601-1-12:2014/AMD1:2020
89 IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
90 basic safety and essential performance of high frequency surgical equipment and high
91 frequency surgical accessories
92 IEC 60601-2-27:2011, Medical electrical equipment – Pa
...