EN IEC 60601-2-19:2021/prA1:2022

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators - Amendment 1

Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren

Amendement 1 -

Medicinska električna oprema - 2-19. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških inkubatorjev - Dopolnilo A1

General Information

• Status: Not Published
• Publication Date: 26-May-2024
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
• Start Date: 27-Jan-2023
• Completion Date: 27-Jan-2023
• Ref Project: SIST EN IEC 60601-2-19:2021/oprA1:2023 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators - Amendment 1

Relations

• Amends: EN IEC 60601-2-19:2021 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
• Effective Date: 26-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-19:2021/oprA1:2023
01-januar-2023
Medicinska električna oprema - 2-19. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti otroških inkubatorjev - Dopolnilo A1

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and

essential performance of infant incubators - Amendment 1

Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren
Ta slovenski standard je istoveten z: EN IEC 60601-2-19:2021/prA1:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN IEC 60601-2- en
19:2021/oprA1:2023

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-19:2021/oprA1:2023
---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-19:2021/oprA1:2023
62D/1984/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-19/AMD1 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-04 2023-01-27
SUPERSEDES DOCUMENTS:
62D/1875/CD, 62D/1968/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 2-19: Particular requirements for the basic safety and

essential performance of infant incubators
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.
---------------------- Page: 3 ----------------------
SIST EN IEC 60601-2-19:2021/oprA1:2023
IEC CDV 60601-2-19:2020 AMD1:2022
© IEC:2022
– 2 –
1 FOREWORD

2 This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC

3 technical committee 62: Electrical equipment in medical practice.
4 The text of this amendment is based on the following documents:
Draft Report on voting
62D/XX/FDIS 62D/XX/RVD

6 Full information on the voting for its approval can be found in the report on voting indicated in

7 the above table.

8 The committee has decided that the contents of this document will remain unchanged until the

9 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

10 the specific document. At this date, the document will be
11 • reconfirmed,
12 • withdrawn,
13 • replaced by a revised edition, or
14 • amended.

16 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

17 organizations may need a transitional period following publication of a new, amended or revised IEC or

18 ISO publication in which to make products in accordance with the new requirements and to equip themselves for

19 conducting new or revised tests. It is the recommendation of the committee that the content of this publication be

20 adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

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 _____________
25 INTRODUCTION to Amendment 1

26 At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed

27 the need for administrative/technical changes to most 62D standards after completion of the

28 amendment projects within the IEC 60601-1 series. Those projects were all completed and the

29 amendments published in 2020.

30 The full list of IEC SC 62D documents that will be amended or revised may be found within the

31 IEC document 62D/1792/DC. The results and comments on the DC may be found within

32 62D1808/INF. The review report for this amendment is 62D/1818/RR.
33 _____________
---------------------- Page: 4 ----------------------
SIST EN IEC 60601-2-19:2021/oprA1:2023
IEC CDV 60601-2-19:2020 AMD1:2022 62D/1984/CDV
© IEC:2022
– 3 –
36 Scope, object and related standards
37 Replace the existing footnote 1 with the following text:

38 The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/

39 AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential

40 performance.
41 201.1.3 * Collateral standards
42 Add asterisk (*) at the beginning of the subclause title:

43 Replace in the existing second paragraph “IEC 60601-1-2:2014 applies” with: “IEC 60601-1-2:2014 and

44 IEC 60601-1-2:2014/AMD1:2020 apply”.
45 Add, after the existing second paragraph the following paragraph:

46 If a BABY CONTROLLED INCUBATOR is based on a temperature measurement which is substantially

47 influenced by the INFANT'S core or body temperature IEC 60601-1-10:2007, IEC 6060-1-

48 10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 apply. Examples for temperature

49 measurements stipulating applicability of IEC 60601-1-10:2007, IEC 6060-1-10:2007/AMD1:2013 and

50 IEC 60601-1-10:2007/AMD2:2020 are provided in Annex AA.
51 201.1.4 * Particular standards

52 Replace the existing third paragraph “IEC 60601-1 and IEC 60601-1:2005/AMD1:2012” with ”

53 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
54 Add, after the existing last paragraph, the following paragraph:

55 If an INFANT INCUBATOR is supplied with dedicated physiological monitoring, then IEC 80601-2-

56 49 [15] applies. Measured parameters related to the inherent function of an INFANT INCUBATOR

57 i.e. the SKIN TEMPERATURE, are not considered to be a physiological monitoring unit as per IEC

58 80601-2-49 [15].
59 201.2 Normative references

60 Replace the existing references to IEC 60601-1 and IEC 60601-1-2 with the following new references:

61 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

62 and essential performance
63 Amendment 1:2012
64 Amendment 2:2020

65 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

66 safety and essential performance – Collateral standard: Electromagnetic disturbances –

67 Requirements and tests
68 Amendment 1:2020
69 201.3 Terms and definitions

70 Replace, in the existing first paragraph, “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012” with

71 “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.

72 201.3.208
73 INFANT
74 Add, after the existing first paragraph, the following note:

75 Note 1 to entry: INFANT includes premature/pre-born baby and neonate baby/newborn baby.

76 Add, after the existing definition 201.3.212, the following new term and definition:

---------------------- Page: 5 ----------------------
SIST EN IEC 60601-2-19:2021/oprA1:2023
IEC CDV 60601-2-19:2020 AMD1:2022
© IEC:2022
– 4 –
77 201.3.213
78 LOW FREQUENCY ELECTROMAGNETIC FIELDS
79 ELECTROMAGNETIC FIELDS with a frequency below 400 kHz
80 201.7.9.2.9 Operating instructions
81 Add, after the final paragraph of existing list item d), the following text:

82 e) * a specification of the LOW FREQUENCY ELECTROMAGNETIC FIELD strength of the INFANT

83 INCUBATOR measured as specified below

84 The LOW FREQUENCY ELECTROMAGNETIC FIELD strength of the INFANT INCUBATOR is measured

85 according to the following procedure:

86 Calibrated sensors for the electromagnetic magnetic field strength in the range of 10 Hz to 400

87 kHz shall be placed at the point M (see Figure 201.102) in a plane parallel to and 5 cm above

88 the MATTRESS surface.

89 The INFANT INCUBATOR is operated as an AIR CONTROLLED INCUBATOR at a CONTROL TEMPERATURE

90 of 36 °C until STEADY TEMPERATURE CONDITION is reached. The LOW FREQUENCY

91 ELECTROMAGNETIC FIELD strength components in the vertical (z) and two perpendicular directions

92 (x and y) are then measured as a temporal average value for T = 10 min for the point M. The

93 scalar product 𝐻 shall then be calculated as
2 2 2
̅ ̅ ̅ ̅
94 𝐻 = √ 𝐻 + 𝐻 + 𝐻
𝑀 𝑀 𝑥 𝑀 𝑦 𝑀 𝑧
̅ ̅ ̅
95 from the time-averaged components 𝐻 , 𝐻 , 𝐻
𝑥 𝑦 𝑧
∆𝑇
96 𝐻 = ∫ 𝐻 𝑑𝑡 (𝑤𝑖𝑡ℎ 𝑛 = 𝑥, 𝑦, 𝑧)
𝑀 𝑛 𝑀 𝑛
∆𝑇
𝑡=0

97 Given the sensor already provides a scalar value of the magnetic field strength calculation of

98 the scalar product is skipped. The scalar product 𝐻 shall be disclosed in the instructions for

99 use.
100 201.9.6.2.1.101 * Sound level within the COMPARTMENT
101 Replace the existing first paragraph with:

102 In NORMAL USE, the sound level within the COMPARTMENT shall not exceed a sound pressure level

103 of L = 55 dB A and L = 75 dB A except as specified in 201.9.6.2.1.103.
eq,1h F,max
104 201.9.6.2.1.102 * Audible alarm sound level
105 Replace the existing text of this subclause with:

106 The auditory HIGH PRIORITY and MEDIUM PRIORITY ALARM SIGNALS shall have a sound level of at

107 least 57 dBA. The auditory alarm may be adjusted by the OPERATOR to a minimum lower level

108 of 42 dBA.

109 Compliance is checked by inspection and measurement of the audible alarm level as specified

110 in 6.3.3.2 of IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-

111 8:2006/AMD2:2020. For this test, the INFANT INCUBATOR shall be operated at a CONTROL

112 TEMPERATURE of 36°C and at a maximum humidity.

113 Add, at the end of the existing subclause 201.11.6.6, the following new subclause:

114 201.11.7 *Biocompatibility of ME equipment and ME systems
115 Add after the existing first paragraph the following text:

116 aa) The COMPARTMENT of an INFANT INCUBATOR shall be evaluated for biocompatibility

117 according to ISO 18562-1:2017.
---------------------- Page: 6 ----------------------
SIST EN IEC 60601-2-19:2021/oprA1:2023
IEC CDV 60601-2-19:2020 AMD1:2022 62D/1984/CDV
© IEC:2022
– 5 –

118 bb) Those parts of COMPARTMENT which are in direct contact with the INFANT’S skin shall be

119 evaluated for biocompatibility according to ISO 10993-1:2018.

120 If testing is required compliance is checked by testing under the following conditions:

121 The INFANT INCUBATOR is operated as an AIR CONTROLLED INCUBATOR at a CONTROL TEMPERATURE

122 of 37 °C and if provided at a humidity level of 80 % relative humidity in STEADY TEMPERATURE

123 CONDITION for 30 days. During this time reprocessing is performed according to and in intervals

124 as specified in the instructions for use.
125 201.12.1.105 * Accuracy of INCUBATOR TEMPERATURE indication
126 Replace the existing third paragraph with:

127 The AVERAGE TEMPERATURE device reading shall not differ from the AVERAGE INCUBATOR

128 TEMPERATURE, measured by a standard thermometer, by more than 0.9 °C, less the standard

129 thermometer error. The standard thermometer shall be accurate within 0,15 °C. It shall have

130 a measuring range of at least 20 °C to 40 °C. If the temperature sensitive component of any

131 device is located at a point where the air temperature consistently differs from the INCUBATOR

132 TEMPERATURE, the device may be specially calibrated with an offset in order to meet the above

133 requirements. However, in this case, full details of the special calibration shall be specified in

134 the ACCOMPANYING DOCUMENTS.
135 20
...