SIST EN IEC 60601-2-20:2020/kFprA1:2023

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators - Amendment 1

Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säglings-Tranportinkubatoren

Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés

Medicinska električna oprema - 2-20. del: Posebne zahteve za osnovno varnost in bistvene lastnosti prenosnih otroških inkubatorjev - Dopolnilo A1

General Information

• Status: Not Published
• Public Enquiry End Date: 26-Jan-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 21-Aug-2023
• Due Date: 09-Oct-2023
• Completion Date: 28-Aug-2023
• Ref Project: EN IEC 60601-2-20:2020/FprA1:2023 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

Relations

• Amends: SIST EN IEC 60601-2-20:2020 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2020)
• Effective Date: 26-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-20:2020/oprA1:2023
01-januar-2023
Medicinska električna oprema - 2-20. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti prenosnih otroških inkubatorjev - Dopolnilo A1
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and
essential performance of infant transport incubators - Amendment 1
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säglings-Tranportinkubatoren
Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs de transport pour nouveau-nés
Ta slovenski standard je istoveten z: EN IEC 60601-2-20:2020/prA1:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN IEC 60601-2- en
20:2020/oprA1:2023
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-20:2020/oprA1:2023
62D/1986/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-20/AMD1 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-04 2023-01-27
SUPERSEDES DOCUMENTS:
62D/1874/CD, 62D/1967/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 2-20: Particular requirements for the basic safety
and essential performance of infant transport incubators

PROPOSED STABILITY DATE: 2028

NOTE FROM TC/SC OFFICERS:

1
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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2 FOREWORD
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
62D/XX/FDIS 62D/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/1817/RR.
34 _____________
35

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36
37
38 Scope, object and related standards
39 Replace the existing footnote 1 with the following text:
40 The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
41 1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and
42 essential performance.
43 201.1.3 * Collateral standards
44 Add an asterisk (*) at the beginning of the subclause title.
45 Replace, in the existing second paragraph, “IEC 60601-1-2:2014” with “IEC 60601-1-2:2014 and IEC
46 60601-1-2/AMD1:2020” and “IEC 60601-1-12:2014” with “IEC 60601-1-12:2014 and IEC 60601-1-
47 12/AMD1:2020”.
48
49 Add, after the existing second paragraph the following paragraph:
50 If a BABY CONTROLLED TRANSPORT INCUBATOR is based on a temperature measurement which is
51 substantially influenced by the INFANT'S core or body temperature IEC 60601-1-10:2007, IEC 6060-1-
52 10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 apply. Examples for temperature
53 measurements stipulating applicability of IEC 60601-1-10:2007, IEC 6060-1-10:2007/AMD1:2013 and
54 IEC 60601-1-10:2007/AMD2:2020 are provided in Annex AA.
55 201.1.4 * Particular standards
56 Replace, in the existing third paragraph, “IEC 60601-1 and IEC 60601-1:2005/AMD1:2012” with
57 “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
58 Add, after the existing last paragraph, the following paragraph:
59 If an INFANT TRANSPORT INCUBATOR is supplied with dedicated physiological monitoring, then IEC 80601-
60 2-49 [9] applies. Measured parameters related to the inherent function of an INFANT TRANSPORT
61 INCUBATOR i.e. the SKIN TEMPERATURE, are not considered to be a physiological monitoring unit as per
62 IEC 80601-2-49 [9].
63 201.2 Normative references
64 Replace the existing references to IEC 60601-1 and IEC 60601-1-2 with the following new references:
65 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
66 and essential performance
67 Amendment 1:2012
68 Amendment 2:2020
69 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
70 safety and essential performance – Collateral standard: Electromagnetic disturbances –
71 Requirements and tests
72 Amendment 1:2020
73
74 Addition:
75
76 IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
77 safety and essential performance – Collateral Standard: General requirements, tests and
78 guidance for alarm systems in medical electrical equipment and medical electrical systems
79 Amendment 1:2012
80 Amendment 2:2020

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81 201.3 Terms and definitions
82 Replace, in the existing first paragraph, “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012” with
83 “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
84
85 201.3.203
86 AVERAGE TRANSPORT INCUBATOR TEMPERATURE
87 Replace, in the existing first paragraph, “INFANT TRANSPORT INCUBATOR TEMPERATURE” with
88 “TRANSPORT INCUBATOR TEMPERATURE”.
89 201.3.207
90 INFANT
91 Add, after the existing first paragraph, the following note:
92 Note 1 to entry: INFANT includes premature/pre-born baby and neonate baby/newborn baby.
93 201.4.10.102 Capacity of transportable electrical power source
94 Replace, in the existing third paragraph, “INFANT TRANSPORT INCUBATOR TEMPERATURE” with
95 “TRANSPORT INCUBATOR TEMPERATURE”.
96 201.9.6.2.1.102 * Audible alarm sound level
97 Replace the existing text of this subclause with:
98 The auditory HIGH PRIORITY and MEDIUM PRIORITY ALARM SIGNALS shall have a sound level of at
99 least 57 dBA. The auditory alarm may be adjusted by the OPERATOR to a minimum lower level
100 of 42 dBA.
101 Compliance is checked by inspection and measurement of the audible alarm level as specified
102 in 6.3.3.2 of IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-
103 8:2006/AMD2:2020. For this test, the INFANT TRANSPORT INCUBATOR shall be operated at a
104 CONTROL TEMPERATURE of 36°C and at a maximum humidity.
105 201.12.1.105 * Accuracy of TRANSPORT INCUBATOR TEMPERATURE indication
106 Replace the existing third paragraph with:
107 The AVERAGE TEMPERATURE device reading shall not differ from the AVERAGE TRANSPORT
108 INCUBATOR TEMPERATURE, measured by a standard thermometer, by more than 1.1 °C, less the
109 standard thermometer error. The standard thermometer shall be accurate within 0,15 °C. It
110 shall have a measuring range of at least 20 °C to 40 °C. If the temperature sensitive component
111 of any device is located at a point where the air temperature consistently differs from the
112 TRANSPORT INCUBATOR TEMPERATURE, the device may be specially calibrated with an offset in
113 order to meet the above requirements. However, in this case, full details of the special
114 calibration shall be specified in the ACCOMPANYING DOCUMENTS.
115 202 * Electromagnetic disturbances – Requirements and tests
116 Add an asterisk (*) at the beginning of the clause title.
117 Replace the existing first paragraph with
118 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply, except as follows:
119 202.8.9 IMMUNITY TEST LEVELS
120 Replace the text of the existing second list item with:
121 – shall continue to perform its intended function as specified by the MANUFACTURER at a level
122 up to 3 V/m for the frequency range of IEC 60601-1-2:2014 and IEC 60601-1-
123 2:2014/AMD1:2020;

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124 212 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
125 SYSTEMS intended for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT
126 Replace, in the entire clause, the reference “IEC 60601-1-12:2014” with “IEC 60601-1-12:2014 and
127 IEC 60601-1-12:2014/AMD1:2020“
...