Iec 60601 2 20 2020

IEC 60601-2-20
®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

iTeh STANDARD PREVIEW
Part 2-20: Particular requirements for the basic safety and essential performance
(standards.iteh.ai)
of infant transport incubators
IEC 60601-2-20:2020
Appareils électromédicaux –
https://standards.iteh.ai/catalog/standards/sist/cc54f6c8-4b8a-49f2-94d6-
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
1ea1298b5df7/iec-60601-2-20-2020
essentielles des incubateurs de transport pour nouveau-nés
IEC 60601-2-20:2020-09(en-fr)
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IEC 60601-2-20
®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – iTeh STANDARD PREVIEW

Part 2-20: Particular requirements for the basic safety and essential
(standards.iteh.ai)
performance of infant transport incubators
IEC 60601-2-20:2020
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
1ea1298b5df7/iec-60601-2-20-2020
essentielles des incubateurs de transport pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-9981-4
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission

Marque déposée de la Commission Electrotechnique Internationale
–2– IEC 60601-2-20:2020 © IEC 2020
CONTENTS
FOREWORD ........................................................................................................................... 3
INTRODUCTION ..................................................................................................................... 6
201.1 Scope, object and related standards ....................................................................... 7
201.2 Normative references .............................................................................................. 9
201.3 Terms and definitions.............................................................................................. 9
201.4 General requirements ........................................................................................... 11
201.5 General requirements for testing ME EQUIPMENT .................................................... 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .................................................... 13
201.7 M E EQUIPMENT identification, marking and documents ........................................... 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ..................................... 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ........... 15
201.10 Protection against unwanted and excessive radiation HAZARDS ............................. 18
201.11 Protection against excessive temperatures and other HAZARDS ............................. 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs ................................................................................................................. 20
201.13 H AZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................... 26
201.14 iTeh STANDARD PREVIEW
P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) ............................................. 27
201.15 Construction of ............................................................................... 27
ME EQUIPMENT
(standards.iteh.ai)
201.16 M E SYSTEMS .......................................................................................................... 29
201.17 Electromagnetic compatibility
IECof60601-2-20:2020
ME EQUIPMENT and ME SYSTEMS ........................... 29
202 Electromagnetic disturbances – Requirements and tests ....................................... 29
1ea1298b5df7/iec-60601-2-20-2020
212 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS intended for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT ........ 29
212.5 * Classification of ME EQUIPMENT and ME SYSTEMS .................................................. 30
212.7 * Protection against electrical HAZARDS from ME EQUIPMENT ................................... 30
212.9 Accuracy of controls and instruments and protection against hazardous
outputs ................................................................................................................. 30
Annexes ............................................................................................................................... 31
Annex AA (informative) Particular guidance and rationale .................................................... 32
Bibliography .......................................................................................................................... 42
Index of defined terms used in this particular standard.......................................................... 43
Figure 201.101 – Variation of INCUBATOR TEMPERATURE ......................................................... 10

Figure 201.102 – Positioning of air temperature sensors ....................................................... 11
Figure 201.103 – Layout of weight test devices ..................................................................... 24
Figure AA.1 – Illustration of the main requirements of this document .................................... 32
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements ........................................ 12

IEC 60601-2-20:2020 © IEC 2020 –3–
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-20: Particular requirements for the basic safety and

essential performance of infant transport incubators
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
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with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
(standards.iteh.ai)
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
IEC 60601-2-20:2020
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
1ea1298b5df7/iec-60601-2-20-2020
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-20 has been prepared by IEC Subcommittee 62D
Electromedical equipment, of IEC Technical Committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2009 and
Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: re-dating of normative references.
–4– IEC 60601-2-20:2020 © IEC 2020
The text of this International Standard is based on the following documents:
FDIS Report on voting

62D/1763/FDIS 62D/1773/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;

– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN C LAUSE 3 OF THE GENERAL STANDARD , IN THIS PARTICULAR STANDARD OR AS
NOTED : SMALL CAPITALS .
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
–
"subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7). (standards.iteh.ai)
References to clauses within this document are preceded by the term "Clause" followed by
IEC 60601-2-20:2020
the clause number.https://standards.iteh.ai/catalog/standards/sist/cc54f6c8-4b8a-49f2-94d6-
References to subclauses within this particular standard are by number
only. 1ea1298b5df7/iec-60601-2-20-2020
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
IEC 60601-2-20:2020 © IEC 2020 –5–
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

(standards.iteh.ai)
IEC 60601-2-20:2020
1ea1298b5df7/iec-60601-2-20-2020
–6– IEC 60601-2-20:2020 © IEC 2020
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT TRANSPORT INCUBATOR
equipment.
This particular standard amends and supplements IEC 60601-1, Medical electrical equipment
– Part 1: General requirements for basic safety and essential performance, hereinafter
referred to as the "general standard".
The requirements are followed by specifications for the relevant tests.
A general guidance and rationale for the requirements of this particular standard are given in
Annex AA. It is considered that knowledge of the reasons for these requirements will not only
facilitate the proper application of this particular standard but will, in due course, expedite any
revision necessitated by changes in clinical practice or as a result of developments in
technology. However, Annex AA does not form part of the requirements of this document.

(standards.iteh.ai)
IEC 60601-2-20:2020
1ea1298b5df7/iec-60601-2-20-2020
IEC 60601-2-20:2020 © IEC 2020 –7–
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-20: Particular requirements for the basic safety and

essential performance of infant transport incubators
201.1 Scope, object and related standards
Clause 1 of the general standard 1 applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
TRANSPORT INCUBATOR equipment, as defined in 201.3.208, also referred to as ME EQUIPMENT .
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to

ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS , as relevant.

H AZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document,
(standards.iteh.ai)
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard. IEC 60601-2-20:2020

This particular standard specifies safety requirements for INFANT TRANSPORT
1ea1298b5df7/iec-60601-2-20-2020 INCUBATORS , but
alternate methods of compliance with a specific clause, by demonstrating equivalent safety,
will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK
MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an
acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– devices supplying heat via BLANKETS , PADS or MATTRESSES in medical use; for information,
see IEC 60601-2-35 [1] 2;
– INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR ; for information see
IEC 60601-2-19 [2];
– INFANT RADIANT WARMERS ; for information, see IEC 60601-2-21 [3];
– INFANT PHOTOTHERAPY ; for information, see IEC 60601-2-50 [4].
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT TRANSPORT INCUBATORS as defined in 201.3.208, which
minimize HAZARDS to the PATIENT and OPERATOR , and to specify tests by which compliance
with the requirements can be verified.
____________
1 The general standard is IEC 60601-1 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance.
2 Figures between square brackets refer to the Bibliography.
–8– IEC 60601-2-20:2020 © IEC 2020
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 and IEC 60601-1-12:2014 apply as modified in Clauses 202 and 212.
IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601-1 series apply as published.
201.1.4 * Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 and IEC 60601-1:2005/AMD1:2012 are referred to in this particular
standard as the general standard. Collateral standards are referred to by their document
number. iTeh STANDARD PREVIEW
(standards.iteh.ai)
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) IEC or 60601-2-20:2020
applicable collateral standard with the prefix "20x"
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses 1ea1298b5df7/iec-60601-2-20-2020
the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard and
applicable collateral standards are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
IEC 60601-2-20:2020 © IEC 2020 –9–
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
S KIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED TRANSPORT
INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in
the sense of the particular standard ISO 80601-2-56.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
ISO 32, Gas cylinders for medical use – Marking for identification of content
ISO 407, Small medical gas cylinders – Pin-index yoke-type valve connections
(standards.iteh.ai)
Replacement:
IEC 60601-2-20:2020
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
1ea1298b5df7/iec-60601-2-20-2020
Requirements and tests
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/

• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 43.
Addition:
201.3.201
AIR CONTROLLED TRANSPORT INCUBATOR
INCUBATOR in which the air temperature is automatically controlled by an air temperature
sensor close to a value set by the OPERATOR
201.3.202
AVERAGE TEMPERATURE
average of temperature readings taken at regular intervals at any specified point in the
COMPARTMENT achieved during STEADY TEMPERATURE CONDITION
– 10 – IEC 60601-2-20:2020 © IEC 2020
201.3.203
AVERAGE TRANSPORT INCUBATOR TEMPERATURE
average of the INFANT TRANSPORT INCUBATOR TEMPERATURE readings taken at regular intervals
achieved during STEADY TEMPERATURE CONDITION
SEE Figure 201.101

Figure 201.101 – Variation of INCUBATOR TEMPERATURE
201.3.204 (standards.iteh.ai)
BABY CONTROLLED TRANSPORT INCUBATOR
AIR CONTROLLED TRANSPORT INCUBATOR IECwhich has the additional capability of automatically
60601-2-20:2020
controlling the INCUBATOR air temperature in order to maintain the temperature as measured
by a SKIN TEMPERATURE SENSOR according to the CONTROL TEMPERATURE set by the OPERATOR
1ea1298b5df7/iec-60601-2-20-2020
201.3.205
COMPARTMENT
environmentally-controlled enclosure intended to contain an INFANT and with transparent
section(s) which allows for viewing of the INFANT
201.3.206
CONTROL TEMPERATURE
temperature selected at the temperature control
201.3.207
INFANT
PATIENT up to the age of three months and a weight less than 10 kg
* 201.3.208
INFANT TRANSPORT INCUBATOR
TRANSPORTABLE ME EQUIPMENT that is equipped with a COMPARTMENT and a TRANSPORTABLE
ELECTRICAL POWER SOURCE with the means to control the environment of the INFANT primarily
by heated air within the COMPARTMENT
201.3.209
SKIN TEMPERATURE
temperature of the skin of the INFANT at a point on which the SKIN TEMPERATURE SENSOR is
placed
IEC 60601-2-20:2020 © IEC 2020 – 11 –
201.3.210
SKIN TEMPERATURE SENSOR
sensing device intended to measure the INFANT 's SKIN TEMPERATURE
201.3.211
STEADY TEMPERATURE CONDITION
condition reached when the TRANSPORT INCUBATOR TEMPERATURE does not vary by more than
1 °C over a period of 1 h
SEE Figure 201.101
201.3.212
TRANSPORT INCUBATOR TEMPERATURE
temperature of the air at a point 10 cm above the centre of the MATTRESS surface in the
COMPARTMENT
SEE Figure 201.102, point M

(standards.iteh.ai)
Key IEC 60601-2-20:2020
M https://standards.iteh.ai/catalog/standards/sist/cc54f6c8-4b8a-49f2-94d6-
T RANSPORT INCUBATOR TEMPERATURE sensor
1ea1298b5df7/iec-60601-2-20-2020
A, B, C, D air temperature sensor
The measuring points A to D and M are in a plane parallel to and at a distance of 10 cm from the MATTRESS .
Figure 201.102 – Positioning of air temperature sensors
201.3.213
TRANSPORTABLE ELECTRICAL POWER SOURCE
rechargeable battery and battery charger intended to provide the electrical power necessary
to operate the INFANT TRANSPORT INCUBATOR
201.4 General requirements
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
For ME EQUIPMENT which combines alternative heat sources, for instance INCUBATORS with
integrated INFANT RADIANT WARMERS , devices supplying heat via BLANKETS , PADS or
MATTRESSES , etc., the safety requirements of the particular standards for these alternative
heat sources, if any, shall be met. The safety requirements of this particular standard shall not
be altered by such additional heat sources specified by the MANUFACTURER , details of which
are provided in the instruction for use.
Compliance is checked by the tests of Clause 201.11 and 201.15.4.2.1 of the relevant
particular standards.
– 12 – IEC 60601-2-20:2020 © IEC 2020
201.4.3 * E SSENTIAL PERFORMANCE
Addition:
201.4.3.101 E SSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATORS
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in

Table 201.101.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
E SSENTIAL PERFORMANCE requirement 1 201.12.1.104 or generation of a visual and audible
alarm in compliance with 201.9.6.2.1.102
E SSENTIAL PERFORMANCE requirement 2 201.12.1.106 or generation of a visual and audible
alarm in compliance with 201.9.6.2.1.102
201.4.10 Power supply
Additional subclauses:
201.4.10.101 * Ability to operate with different power supply sources
The INFANT TRANSPORT INCUBATOR shall have a TRANSPORTABLE ELECTRICAL POWER SOURCE
consisting of a rechargeable battery and battery charger designed to operate from an
alternating current supply voltage. It shall also be designed to operate from at least one
(standards.iteh.ai)
external direct and one external alternating current SUPPLY MAINS as specified in the
instructions for use. All requirements of the general standard and this particular standard shall
continue to be met. IEC 60601-2-20:2020
Compliance is checked by repeating the tests in 201.12.1.101, 201.12.1.102, 201.12.1.104
1ea1298b5df7/iec-60601-2-20-2020
and 201.12.1.106 with the INFANT TRANSPORT INCUBATOR operating at an ambient temperature
of 15 °C ± 1 °C when supplied from each of its SUPPLY MAINS in turn. This also includes the
TRANSPORTABLE ELECTRICAL POWER SOURCE .
201.4.10.102 Capacity of TRANSPORTABLE ELECTRICAL POWER SOURCE
The capacity of any TRANSPORTABLE ELECTRICAL POWER SOURCE shall be sufficient to maintain
the INFANT TRANSPORT INCUBATOR at a temperature in accordance with the following test during
at least 90 min.
Compliance is checked by inspection and the following test:
The INFANT TRANSPORT INCUBATOR with a fully charged battery shall be placed in an
environment with an ambient temperature of 15 °C ± 1 °C. It shall be operated from the
SUPPLY MAINS until a STEADY TEMPERATURE CONDITION has been established at a CONTROL
TEMPERATURE of 36 °C and then set to operate from any TRANSPORTABLE ELECTRICAL POWER
SOURCE . The INFANT TRANSPORT INCUBATOR TEMPERATURE shall be maintained within 2 °C of
the CONTROL TEMPERATURE .
This test shall be conducted while all the electrical powered ACCESSORIES , as specified by the
MANUFACTURER , are in operation and making the maximum demand upon the external
TRANSPORTABLE ELECTRICAL POWER SOURCE .
201.4.10.103 Overcharge of TRANSPORTABLE ELECTRICAL POWER SOURCE
It shall not be possible to overcharge and damage the TRANSPORTABLE ELECTRICAL POWER
SOURCE even if the ME EQUIPMENT is left connected to the AC electrical power source for an
indefinite period. Controls which affect the rate of recharge or the final battery voltage level
shall not be accessible to the OPERATOR without the aid of a TOOL .
IEC 60601-2-20:2020 © IEC 2020 – 13 –
Compliance is checked by inspection.
201.5 General requirements for testing ME EQUIPMENT
201.5.3 * Ambient temperature, humidity, atmospheric pressure
Addition to a):
The ME EQUIPMENT shall comply with the requirements of this document when operating within
an ambient temperature between +10 °C and +30 °C.
If not otherwise specified in this particular standard, all tests shall be carried out at an
ambient temperature within the range of 21 °C to 26 °C and an ambient air velocity less than
1,0 m/s and greater than 0,3 m/s.
201.5.4 Other conditions
Addition item to the existing list:
aa) If not otherwise specified, the CONTROL TEMPERATURE shall be 36 °C and shall always
exceed the ambient temperature by at least 3 °C.
201.6 Classification of ME(standards.iteh.ai)
EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.

IEC 60601-2-20:2020
1ea1298b5df7/iec-60601-2-20-2020
201.7 M E EQUIPMENT identification, marking and documents
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts

(see also Table C.1 of the general standard)
Additional subclauses:
201.7.2.101 * Oxygen monitor
An INFANT TRANSPORT INCUBATOR not equipped with an integral oxygen monitor and which
provides means for oxygen administration shall be marked in a prominent position with a text
which states: "Use an oxygen monitor when oxygen is administered".
NOTE See also 7.5 of the general standard.
201.7.2.102 Heater surface temperature
If a heater is accessible without the use of a TOOL , a notice, symbol (see 7.5 of the general
standard) or marking shall be displayed adjacent to the heater giving warning of high surface
temperature.
201.7.4 Marking of controls and instruments (see also Table C.3 of the general standard)
201.7.4.2 * Control devices
Addition:

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Medical electrical equipment –

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Medical electrical equipment – iTeh STANDARD PREVIEW

ICS 11.040.10 ISBN 978-2-8322-9981-4

® Registered trademark of the International Electrotechnical Commission

Figure 201.101 – Variation of INCUBATOR TEMPERATURE ......................................................... 10

Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements ........................................ 12

INTERNATIONAL ELECTROTECHNICAL COMMISSION

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-20: Particular requirements for the basic safety and

iTeh STANDARD PREVIEW

The text of this International Standard is based on the following documents:

FDIS Report on voting

In this document, the following print types are used:

– requirements and definitions: roman type;

In referring to the structure of this document, the term

iTeh STANDARD PREVIEW

The requirements are followed by specifications for the relevant tests.

iTeh STANDARD PREVIEW

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-20: Particular requirements for the basic safety and

201.1 Scope, object and related standards

Clause 1 of the general standard 1 applies, except as follows:

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to

iTeh STANDARD PREVIEW

NOTE See also 4.2 of the general standard. IEC 60601-2-20:2020

This particular standard does not apply to:

201.1.3 Collateral standards

201.1.4 * Particular standards

A requirement of a particular standard takes priority over the general standard.

201.2 Normative references

NOTE Informative references are listed in the Bibliography.

Clause 2 of the general standard applies, except as follows:

201.3 Terms and definitions

• IEC Electropedia: available at http://www.electropedia.org/

SEE Figure 201.101

iTeh STANDARD PREVIEW

SEE Figure 201.101

SEE Figure 201.102, point M

iTeh STANDARD PREVIEW

Figure 201.102 – Positioning of air temperature sensors

201.4 General requirements

Clause 4 of the general standard applies, except as follows:

201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS

201.4.3 * E SSENTIAL PERFORMANCE

201.4.3.101 E SSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATORS

Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in

Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements

201.4.10 Power supply

201.4.10.101 * Ability to operate with different power supply sources

201.4.10.102 Capacity of TRANSPORTABLE ELECTRICAL POWER SOURCE

Compliance is checked by inspection and the following test:

201.4.10.103 Overcharge of TRANSPORTABLE ELECTRICAL POWER SOURCE