IEC 60601-2-20:2009
(Main)Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
IEC 60601-2-20:2009 specifies safety requirements for infant transport incubators. This particular standard amends and supplements IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This second edition cancels and replaces the first edition of IEC 60601-2-20 published in 1990 and its Amendment 1 (1996). This edition constitutes a technical revision. This edition of IEC 60601 2-20 was revised to structurally align with the 2005 edition of IEC 60601-1. The contents of the corrigenda of February 2012 and February 2013 have been included in this copy.
Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés
La CEI 60601-2-20:2009 spécifie les exigences de sécurité relatives aux incubateurs de transport pour nouveau-nés. La présente norme particulière modifie et complète la CEI 60601-1:2005: Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-20 parue en 1990 et son Amendement 1 (1996). Cette édition constitue une révision technique. La présente édition de la CEI 60601 2-20 a été mise à jour de façon à correspondre structurellement à l'édition 2005 de la CEI 60601-1. Le contenu des corrigendum de février 2012 et février 2013 a été pris en considération dans cet exemplaire.
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IEC 60601-2-20 ®
Edition 2.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential performance
of infant transport incubators
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs de transport pour nouveau-nés
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IEC 60601-2-20 ®
Edition 2.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential performance
of infant transport incubators
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs de transport pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.10 ISBN 978-2-88910-218-1
– 2 – 60601-2-20 © IEC:2009
CONTENTS
FOREWORD.3
INTRODUCTION.5
201.1 Scope, object and related standards .6
201.2 Normative references .8
201.3 Terms and definitions.8
201.4 General requirements.10
201.5 General requirements for testing ME EQUIPMENT.12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .12
201.7 ME EQUIPMENT identification, marking and documents.12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.14
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.19
201.13 HAZARDOUS SITUATIONS and fault conditions.26
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .26
201.15 Construction of ME EQUIPMENT .26
201.16 ME SYSTEMS .28
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .28
202 Electromagnetic compatibility – Requirements and tests .28
210 Requirements for the development of physiologic closed-loop controllers .29
Annexes .29
Annex AA (informative) Particular guidance and rationale.30
Bibliography.38
Index of defined terms used in this particular standard.39
Figure 201.101 – Positioning of air temperature sensors.10
Figure 201.102 – AVERAGE TRANSPORT INCUBATOR TEMPERATURE .10
Figure 201.103 – Layout of weight test devices.23
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements.11
60601-2-20 © IEC:2009 – 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
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equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
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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 second edition cancels and replaces the first edition of IEC 60601-2-20 published in
1990 and its Amendment 1 (1996). This edition constitutes a technical revision. This edition of
IEC 60601-2-20 was revised to structurally align with the 2005 edition of IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/731/FDIS 62D/757/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
– 4 – 60601-2-20 IEC:2009
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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.
ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
– T
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, 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).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
The contents of the corrigenda of February 2012 and February 2013 have been included in
this copy.
60601-2-20 © IEC:2009 – 5 –
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 60601-1:2005, 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, this annex does not form part of the requirements of this standard.
– 6 – 60601-2-20 © IEC:2009
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 applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
TRANSPORT INCUBATOR equipment, as defined in 201.3.211 of this standard, 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.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT TRANSPORT 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
1)
see IEC 80601-2-35 [1] ;
– 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 201.3.211, which
minimize HAZARDS to the PATIENT and OPERATOR, and to specify tests by which compliance
with the requirements can be verified.
—————————
1)
Figures between square brackets refer to the Bibliography.
60601-2-20 © IEC:2009 – 7 –
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 2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-10 apply as modified in Clauses 202 and 210 respectively.
IEC 60601-1-3 does 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 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
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 standard addresses the content
of Clause 1 of the general standard) or 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 the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard 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 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses or figures 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 standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
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
– 8 – 60601-2-20 © IEC:2009
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.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
NOTE Informative references are listed in the bibliography beginning on page 38.
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-1-10:2007, 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
ISO 32, Gas cylinders for medical use – Marking for identification of content
ISO 407, Small medical gas cylinders – Pin-index yoke-type valve connections
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
NOTE An index of defined terms is found beginning on page 39.
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
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 201.102)
201.3.204
BABY CONTROLLED TRANSPORT INCUBATOR
AIR CONTROLLED TRANSPORT INCUBATOR which has the additional capability of automatically
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
60601-2-20 © IEC:2009 – 9 –
NOTE An INFANT TRANSPORT INCUBATOR operating as a BABY CONTROLLED INCUBATOR is a PHYSIOLOGIC CLOSED-
LOOP CONTROLLER as defined in IEC 60601-1-10.
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
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 201.102)
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 201.101, point M)
– 10 – 60601-2-20 © IEC:2009
C
A
M
D
B
IEC 253/09
Key
M = INCUBATOR TEMPERATURE sensor
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 201.101 – Positioning of air temperature sensors
INCUBATOR
Temperature
TEMPERATURE
variation
AVERAGE
INCUBATOR
TEMPERATURE
11 °C
Ambient
temperature
Time
Warm up time Steady temperature condition
IEC 254/09
Figure 201.102 – Variation of INCUBATOR TEMPERATURE
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
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
60601-2-20 IEC:2009 – 11 –
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 subclause 201.15.4.2.1 of the
relevant particular standards.
201.4.3 *ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 ESSENTIAL 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
ESSENTIAL PERFORMANCE requirement 1 201.12.1.104 or generation of a
visual and audible alarm in
compliance with 201.9.6.2.1.102
ESSENTIAL 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
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.
Compliance is checked by repeating the tests in subclauses 201.12.1.101, 201.12.1.102,
201.12.1.105 and 201.12.1.107 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
TRANSPORTABLE ELECTRICAL POWER SOURCE.
includes the
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
– 12 – 60601-2-20 © IEC:2009
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 a.c. 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.
Compliance is checked by inspection.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 *Ambient temperature, humidity, atmospheric pressure
Addition to a):
The ME EQUIPMENT shall comply with the requirements of this standard when operating within
the following conditions:
– 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:
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 EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
(see also Table C.1)
Additional subclauses:
60601-2-20 © IEC:2009 – 13 –
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)
201.7.4.2 *Control devices
Addition:
Temperature controls shall be clearly marked with temperature settings on or adjacent to the
control. The markings shall be provided at intervals of not greater than 1 °C for AIR
and not greater than 0,5 °C for BABY CONTROLLED
CONTROLLED TRANSPORT INCUBATORS
TRANSPORT INCUBATORS.
Marking of the maximum and the minimum values of controls and-indicators shall be such that
no confusion can arise with regard to the position of the control and/or the indicated values.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall contain the following additional items:
* a) A statement that a INFANT TRANSPORT INCUBATOR should be used only by appropriately
trained personnel and under the direction of qualified medical personnel familiar with
currently known RISKS and benefits of INFANT TRANSPORT INCUBATOR use.
* b) A warning that direct sunlight or other radiant heat sources can cause an increase in
TRANSPORT INCUBATOR TEMPERATURE to dangerous levels.
* c) A statement that the use of oxygen increases the danger of fire and that auxiliary
equipment producing sparks shall not be placed in the INFANT TRANSPORT INCUBATOR.
* d) A warning that even small quantities of flammable agents, such as ether and alcohol,
left in the INFANT TRANSPORT INCUBATOR can cause fire in connection with oxygen.
e) A warning against possible use of the SKIN TEMPERATURE SENSOR as a rectal
temperature sensor, if such a warning is applicable.
f) A statement of the maximum loads which can be applied to all supports and mounting
brackets for ACCESSORIES and ancillary equipment.
g) For TYPE B APPLIED PARTS, where the INFANT may not be isolated from earth, a warning
that particular care must be taken to ensure that additional ME EQUIPMENT connected to
INFANT is electrically safe.
the
h) An information on how and when to verify the functionality of the ALARM SYSTEM.
COMPARTMENT:
i) For oxygen administration into the
– a warning stating that administration of oxygen may increase the noise level for the
INFANT within the INFANT TRANSPORT INCUBATOR;
– an explanation of the operation of supplementary oxygen equipment supplied for
use with the INFANT TRANSPORT INCUBATOR or as specified in the ACCOMPANYING
DOCUMENTS;
– 14 – 60601-2-20 © IEC:2009
– a statement that an oxygen analyzer shall be used when oxygen is delivered to the
INFANT.
j) Details of any specified combinations of ME EQUIPMENT (see 201.4.1).
201.7.9.2.8 *Start-up PROCEDURE
Addition:
The instructions for use shall additionally contain: a specification of the warm-up time of the
INFANT TRANSPORT INCUBATOR measured as specified in 201.12.1.108.
201.7.9.2.9 *Operating instructions
Addition:
The instructions for use shall contain the following additional items:
*a) A recommendation of the position and method of use of the SKIN TEMPERATURE SENSOR.
*b) Information about the range of CONTROL TEMPERATURE and relative humidity of the INFANT
TRANSPORT INCUBATOR. If the INFANT TRANSPORT INCUBATOR is not supplied with means for
control of the degree of humidity this shall be stated in the instructions for use.
*c) When applicable, a statement of the maximum allowed weight of additional equipment
which might be placed on shelves connected to the INFANT TRANSPORT INCUBATOR.
d) Information on the external supply circuits with which the INFANT TRANSPORT INCUBATOR
can be operated according to 201.4.10.101. Additionally the MANUFACTURER shall specify
in the ACCOMPANYING DOCUMENTS the polarity of the electrical connections as necessary.
e) A statement:
– of the mass and external dimensions of the INFANT TRANSPORT INCUBATOR including
that of the specified external TRANSPORTABLE ELECTRICAL POWER SOURCE and with
oxygen delivery system and trolley, if provided;
– with which means and in what way a fixation of the INFANT TRANSPORT INCUBATOR
within an emergency vehicle is achieved;
– of the minimum ambient temperature, humidity and atmospheric pressure to which the
INFANT TRANSPORT INCUBATOR can be exposed and still meet with the requirements of
this standard;
– of how the INFANT’s movements can be limited within the INFANT TRANSPORT INCUBATOR
during transport.
201.7.9.3 Technical description
201.7.9.3.1 General
Additional item:
– the MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS the maximum CO
concentration (see sub-clause 201.12.4.2.101)
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
60601-2-20 © IEC:2009 – 15 –
201.9.2 HAZARDS associated with moving parts
201.9.2.1 General
Addition at end of the subclause:
This requirement is not applicable to an air circulating fan if it is accessible only when no
INFANT is present in the INFANT TRANSPORT INCUBATOR and appropriate ME EQUIPMENT parts are
removed for cleaning.
201.9.4.2.1 Instability in transport position
Addition:
The INFANT TRANSPORT INCUBATORS shall remain stable when tilted 10° in NORMAL USE and
when tilted 20° during transportation.
Compliance is checked by the following test
The INFANT TRANSPORT INCUBATOR is placed in any possible position of NORMAL USE on a plane
inclined at an angle of 0,18 rad (10°) to the horizontal plane. If wheels are present, they shall
be temporarily fixed in their most disadvantageous position. Doors and drawers and the like
shall be placed in the most disadvantageous position during NORMAL USE. The MATTRESS tray
shall be extended outside the enclosure.
The test shall be repeated at an angle of 0,36 rad (20°), in which case the MATTRESS tray shall
not be extended outside the enclosure. Doors and drawers and the like shall be placed in their
most disadvantageous position during transportation.
201.9.4.3 Instability from unwanted lateral movement (including sliding)
Additional subclauses:
201.9.4.3.101 Tip-over force
The lateral force to cause the INFANT TRANSPORT INCUBATOR to tip over shall be greater than
100 N.
Compliance is checked by the following test:
With the INFANT TRANSPORT INCUBATOR wheels locked and with the ME EQUIPMENT in the worst-
case configuration of parts and ACCESSORIES, a lateral force shall be applied and measured
using a force gauge. The point of application shall be at the highest point of the body of the
ME EQUIPMENT. The INFANT TRANSPORT INCUBATOR shall not tip over when the force is 100 N or
less.
201.9.4.3.102 *Prevention of movements
If the ME EQUIPMENT is mounted on wheels, the MANUFACTURER shall provide a means to
prevent movement of the ME EQUIPMENT on a slope of at least 10° to the horizontal.
Compliance is checked by inspection and by the following test:
Place the ME EQUIPMENT with its wheels in a locked position and with all ACCESSORIES fitted,
on a plane inclined at an angle of 10° to the horizontal. Report whether the ME EQUIPMENT is in
a maintain position.
– 16 – 60601-2-20 IEC:2009
201.9.4.3.103 Prevention of INFANT’S movements
A means shall be provided to limit the INFANT’S movement to a defined area within the
COMPARTMENT during NORMAL USE.
Compliance is checked by inspection.
201.9.4.3.104 *Prevention of vibration
A means should be provided to limit the INFANT’S vibration within the COMPARTMENT during
transportation.
201.9.6.2 Acoustic energy
201.9.6.2.1 Audible acoustic energy
Additional subclauses:
201.9.6.2.1.101 Sound level within the COMPARTMENT
In NORMAL USE the sound level within the COMPARTMENT shall not exceed sound pressure level
of 60 dBA except as specified in subclause 201.9.6.2.1.103.
Compliance is checked by the following test:
With the microphone of a sound level meter complying with the requirements of IEC 61672-1
[5], positioned 100 mm to 150 mm above the centre of the INFANT tray, the measured sound
level shall not exceed the specified values. For this test the INFANT TRANSPORT INCUBATOR
shall be operated at a CONTROL TEMPERATURe of 36 °C and at a maximum humidity. The
background sound level measured inside the COMPARTMENT shall be at least 10 dBA below
that which is measured during the test.
201.9.6.2.1.102 * Audible alarms sound level
Auditory ALARM SIGNALS shall have a sound level of at least 65 dBA at a distance of 3 m
perpendicular to the front of the control unit in a reflecting room. The auditory alarm may be
adjusted by the OPERATOR to a minimum lower level of 50 dB measured with the range setting
of an A-weighted scale. If the frequency of the auditory alarms is adjustable by the OPERATOR,
these requirements shall apply to all the individual selectable frequencies.
Compliance is checked by inspection and measurement of the audible alarm level using a
sound level meter, as required in subclause 201.12.3.104 of this particular standard, placed
1,5 m above the floor and 3 m from the control unit. For this test the TRANSPORT INCUBATOR
shall be operated at a CONTROL TEMPERATURE of 36°C and at a maximum humidity. The
background sound level measured shall be at least 10 dB(A) below that which is measured
during the test.
201.9.6.2.1.103 * Audible alarms sound level within COMPARTMENT
When any INFANT TRANSPORT INCUBATOR alarm is sounding, the sound level in the
COMPARTMENT shall not exceed a sound pressure level of 80 dBA. If the frequency of the
auditory alarms is adjustable by the OPERATOR, this shall apply to all the individual selectable
frequencies.
Compliance is checked by the following test:
The alarm shall be actuated and the measurement shall be carried out as described in
subclause 201.9.6.2.1.101.
60601-2-20 © IEC:2009 – 17 –
201.9.8 HAZARDS associated with support systems
The general standard applies, except as follows:
201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems
201.9.8.3.1 General
Amendment:
The normal load for an INFANT PATIENT is reduced to 10 kg (see 201.3.201).
Additional subclauses:
201.9.8.3.101 *Barriers
For devices with an integral bed, suitable barriers such as walls or side panels shall prevent
the PATIENT from falling off. Barriers intended to be opened or removed to allow access to the
INFANT, such as doors, ports etc., shall close so as not to open under the test conditions
specified below. It shall not be possible for barriers to be insecurely closed or latched whilst
appearing to be engaged. The mechanical integrity of the INFANT TRANSPORT INCUBATOR shall
be maintained under the following test conditions.
Compliance is checked by inspection and by the following test:
With all access port doors deliberately made as insecure as possible, without the use of a
TOOL, whilst still appearing to be engaged, a horizontal force shall be applied to the centre of
the access port door. The force shall be increased gradually from zero to 20 N in an interval
of 5 s – 10 s and shall be held at maximum for 5 s. The barriers shall remain in the closed
position.
201.9.8.3.102 MATTRESS tray
For devices with an integral bed, if the MATTRESS tray can be extended outside the enclosure
it shall be restrained to ensure that the tray remains attached to the INCUBATOR, is supported
and does not tip under the weight of the INFANT.
Compliance is checked by the following test:
A gradually increasing downward force is to be applied to the middle of the outside edge of
the MATTRESS tray whilst in the fully extended position. The force is to be increased over 5 s –
10 s intervals until it equals 100 N and is to be obtained for a period of 1 min. The tray shall
not incline by more than 5° to the horizontal axis of the INCUBATOR and there shall be no
visible evidence of damage to the supporting structures.
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for ACCESSORIES shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following tes
...
IEC 60601-2-20 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential performance
of infant transport incubators
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs de transport pour nouveau-nés
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IEC 60601-2-20 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential
performance of infant transport incubators
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les
performances essentielles des incubateurs de transport pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-3376-4
IEC 60601-2-20 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential performance
of infant transport incubators
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs de transport pour nouveau-nés
– 2 – IEC 60601-2-20:2009+AMD1:2016 CSV
© IEC 2016
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 ME 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 . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201.13 HAZARDOUS SITUATIONS and fault conditions . 27
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
201.15 Construction of ME EQUIPMENT . 27
201.16 ME SYSTEMS . 29
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 29
202 Electromagnetic compatibility – Requirements and tests . 29
210 Requirements for the development of physiologic closed-loop controllers .
212 * Requirements for medical electrical equipment and medical electrical systems
intended for use in the emergency medical services environment . 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 – Positioning of air temperature sensors . 11
Figure 201.102 – Variation of INCUBATOR TEMPERATURE . 11
Figure 201.103 – Layout of weight test devices . 24
Figure AA.1 – Illustration of the main requirements of this standard . 32
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 12
© IEC 2016
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
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patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 60601-2-20 edition 2.1 contains the second edition (2009-02) [documents 62D/731/FDIS and
62D/757/RVD], its corrigendum 1 (2012-02), its corrigendum 2 (2013-02) and its amendment 1
(2016-04) [documents 62D/1325/FDIS and 62D/1346/RVD].
In this Redline version, a vertical line in the margin shows where the technical
content is modified by amendment 1. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is
available in this publication.
– 4 – IEC 60601-2-20:2009+AMD1:2016 CSV
© IEC 2016
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 second edition cancels and replaces the first edition of IEC 60601-2-20 published in
1990 and its Amendment 1 (1996). This edition constitutes a technical revision. This edition of
IEC 60601-2-20 was revised to structurally align with the 2005 edition of IEC 60601-1.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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 CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, 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).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 2016
The committee has decided that the contents of the base publication and its amendment will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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.
– 6 – IEC 60601-2-20:2009+AMD1:2016 CSV
© IEC 2016
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 60601-1:2005, 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, this annex does not form part of the requirements of this standard.
© IEC 2016
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 applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
TRANSPORT INCUBATOR equipment, as defined in 201.3.211 of this standard, 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.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT TRANSPORT 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
1)
see IEC 80601-2-35 [1] ;
– 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 201.3.211, which
minimize HAZARDS to the PATIENT and OPERATOR, and to specify tests by which compliance
with the requirements can be verified.
—————————
1)
Figures between square brackets refer to the Bibliography.
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© IEC 2016
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 2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-10 applies as modified in Clause 202 and 210 respectively.
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 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
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 standard addresses the content
of Clause 1 of the general standard) or 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 the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard 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 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses or figures 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 standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
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
© IEC 2016
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.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED TRANSPORT
INCUBATOR including the displayed value are considered to be not a CLINICAL THERMOMETER in
the sense of the particular standard ISO 80601-2-56.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
NOTE Informative references are listed in the bibliography beginning on page 42.
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-1-10:2007, 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
ISO 32, Gas cylinders for medical use – Marking for identification of content
ISO 407, Small medical gas cylinders – Pin-index yoke-type valve connections
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
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
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 201.102)
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© IEC 2016
201.3.204
BABY CONTROLLED TRANSPORT INCUBATOR
AIR CONTROLLED TRANSPORT INCUBATOR which has the additional capability of automatically
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
NOTE An INFANT TRANSPORT INCUBATOR operating as a BABY CONTROLLED INCUBATOR is a PHYSIOLOGIC CLOSED-
LOOP CONTROLLER as defined in IEC 60601-1-10.
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
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 201.102)
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 201.101, point M)
© IEC 2016
C
A
M
D
B
IEC 253/09
Key
M = INCUBATOR TEMPERATURE sensor
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 201.101 – Positioning of air temperature sensors
INCUBATOR
Temperature
TEMPERATURE
variation
AVERAGE
INCUBATOR
TEMPERATURE
11 °C
Ambient
temperature
Time
Warm up time Steady temperature condition
IEC 254/09
Figure 201.102 – Variation of INCUBATOR TEMPERATURE
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
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
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© IEC 2016
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 subclause 201.15.4.2.1 of the
relevant particular standards.
201.4.3 *ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 ESSENTIAL 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
ESSENTIAL PERFORMANCE requirement 1 201.12.1.104 or generation of a
visual and audible alarm in
compliance with 201.9.6.2.1.102
ESSENTIAL 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
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.
Compliance is checked by repeating the tests in subclauses 201.12.1.101, 201.12.1.102,
201.12.1.105 and 201.12.1.107 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
© IEC 2016
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 a.c. 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.
Compliance is checked by inspection.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 *Ambient temperature, humidity, atmospheric pressure
Addition to a):
ME EQUIPMENT shall comply with the requirements of this standard when operating within
The
the following conditions:
– 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:
CONTROL TEMPERATURE shall be 36 °C and shall always exceed
If not otherwise specified, the
the ambient temperature by at least 3 °C.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
(see also Table C.1)
Additional subclauses:
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© IEC 2016
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)
201.7.4.2 *Control devices
Addition:
Temperature controls shall be clearly marked with temperature settings on or adjacent to the
control. The markings shall be provided at intervals of not greater than 1 °C for AIR
CONTROLLED TRANSPORT INCUBATORS and not greater than 0,5 °C for BABY CONTROLLED
TRANSPORT INCUBATORS.
Marking of the maximum and the minimum values of controls and-indicators shall be such that
no confusion can arise with regard to the position of the control and/or the indicated values.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall contain the following additional items:
* a) A statement that a INFANT TRANSPORT INCUBATOR should be used only by appropriately
trained personnel and under the direction of qualified medical personnel familiar with
currently known RISKS and benefits of INFANT TRANSPORT INCUBATOR use.
* b) A warning that direct sunlight or other radiant heat sources can cause an increase in
TRANSPORT INCUBATOR TEMPERATURE to dangerous levels.
* c) A statement that the use of oxygen increases the danger of fire and that auxiliary
equipment producing sparks shall not be placed in the INFANT TRANSPORT INCUBATOR.
* d) A warning that even small quantities of flammable agents, such as ether and alcohol,
left in the INFANT TRANSPORT INCUBATOR can cause fire in connection with oxygen.
e) A warning against possible use of the SKIN TEMPERATURE SENSOR as a rectal
temperature sensor, if such a warning is applicable.
f) A statement of the maximum loads which can be applied to all supports and mounting
brackets for ACCESSORIES and ancillary equipment.
g) For TYPE B APPLIED PARTS, where the INFANT may not be isolated from earth, a warning
that particular care must be taken to ensure that additional ME EQUIPMENT connected to
the INFANT is electrically safe.
h) An information on how and when to verify the functionality of the ALARM SYSTEM.
i) For oxygen administration into the COMPARTMENT:
– a warning stating that administration of oxygen may increase the noise level for the
INFANT within the INFANT TRANSPORT INCUBATOR;
– an explanation of the operation of supplementary oxygen equipment supplied for
INFANT TRANSPORT INCUBATOR or as specified in the ACCOMPANYING
use with the
DOCUMENTS;
© IEC 2016
– a statement that an oxygen analyzer shall be used when oxygen is delivered to the
INFANT.
j) Details of any specified combinations of ME EQUIPMENT (see 201.4.1).
*k) A statement that the INFANT TRANSPORT INCUBATOR cannot differentiate between an
increase in core temperature with a cold skin (fever) and a low core and SKIN
TEMPERATURE (hypothermia), and a recommendation to monitor the temperature of the
PATIENT.
201.7.9.2.8 *Start-up PROCEDURE
Addition:
The instructions for use shall additionally contain: a specification of the warm-up time of the
INFANT TRANSPORT INCUBATOR measured as specified in 201.12.1.108.
201.7.9.2.9 *Operating instructions
Addition:
The instructions for use shall contain the following additional items:
*a) A recommendation of the position and method of use of the SKIN TEMPERATURE SENSOR.
*b) Information about the range of CONTROL TEMPERATURE and relative humidity of the INFANT
TRANSPORT INCUBATOR. If the INFANT TRANSPORT INCUBATOR is not supplied with means for
control of the degree of humidity this shall be stated in the instructions for use.
*c) When applicable, a statement of the maximum allowed weight of additional equipment
which might be placed on shelves connected to the INFANT TRANSPORT INCUBATOR.
d) Information on the external supply circuits with which the INFANT TRANSPORT INCUBATOR
can be operated according to 201.4.10.101. Additionally the MANUFACTURER shall specify
in the ACCOMPANYING DOCUMENTS the polarity of the electrical connections as necessary.
e) A statement:
– of the mass and external dimensions of the INFANT TRANSPORT INCUBATOR including
that of the specified external TRANSPORTABLE ELECTRICAL POWER SOURCE and with
oxygen delivery system and trolley, if provided;
– with which means and in what way a fixation of the INFANT TRANSPORT INCUBATOR
within an emergency vehicle is achieved;
– of the minimum ambient temperature, humidity and atmospheric pressure to which the
INFANT TRANSPORT INCUBATOR can be exposed and still meet with the requirements of
this standard;
– of how the INFANT’s movements can be limited within the INFANT TRANSPORT INCUBATOR
during transport.
201.7.9.3 Technical description
201.7.9.3.1 General
Additional item:
– the MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS the maximum CO
concentration (see sub-clause 201.12.4.2.101)
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
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© IEC 2016
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.2 HAZARDS associated with moving parts
201.9.2.1 General
Addition at end of the subclause:
This requirement is not applicable to an air circulating fan if it is accessible only when no
INFANT is present in the INFANT TRANSPORT INCUBATOR and appropriate ME EQUIPMENT parts are
removed for cleaning.
201.9.4.2.1 Instability in transport position
Addition:
The INFANT TRANSPORT INCUBATORS shall remain stable when tilted 10° in NORMAL USE and
when tilted 20° during transportation.
Compliance is checked by the following test
The INFANT TRANSPORT INCUBATOR is placed in any possible position of NORMAL USE on a plane
inclined at an angle of 0,18 rad (10°) to the horizontal plane. If wheels are present, they shall
be temporarily fixed in their most disadvantageous position. Doors and drawers and the like
shall be placed in the most disadvantageous position during NORMAL USE. The MATTRESS tray
shall be extended outside the enclosure.
The test shall be repeated at an angle of 0,36 rad (20°), in which case the MATTRESS tray shall
not be extended outside the enclosure. Doors and drawers and the like shall be placed in their
most disadvantageous position during transportation.
201.9.4.3 Instability from unwanted lateral movement (including sliding)
Additional subclauses:
201.9.4.3.101 Tip-over force
The lateral force to cause the INFANT TRANSPORT INCUBATOR to tip over shall be greater than
100 N.
Compliance is checked by the following test:
With the INFANT TRANSPORT INCUBATOR wheels locked and with the ME EQUIPMENT in the worst-
case configuration of parts and ACCESSORIES, a lateral force shall be applied and measured
using a force gauge. The point of application shall be at the highest point of the body of the
ME EQUIPMENT. The INFANT TRANSPORT INCUBATOR shall not tip over when the force is 100 N or
less.
201.9.4.3.102 *Prevention of movements
If the ME EQUIPMENT is mounted on wheels, the MANUFACTURER shall provide a means to
prevent movement of the ME EQUIPMENT on a slope of at least 10° to the horizontal.
Compliance is checked by inspection and by the following test:
© IEC 2016
Place the ME EQUIPMENT with its wheels in a locked position and with all ACCESSORIES fitted,
on a plane inclined at an angle of 10° to the horizontal. Report whether the ME EQUIPMENT is in
a maintain position.
201.9.4.3.103 Prevention of INFANT’S movements
A means shall be provided to limit the INFANT’S movement to a defined area within the
COMPARTMENT during NORMAL USE.
Compliance is checked by inspection.
201.9.4.3.104 *Prevention of vibration
A means should be provided to limit the INFANT’S vibration within the COMPARTMENT during
transportation.
201.9.6.2 Acoustic energy
201.9.6.2.1 Audible acoustic energy
Additional subclauses:
201.9.6.2.1.101 Sound level within the COMPARTMENT
In NORMAL USE the sound level within the COMPARTMENT shall not exceed sound pressure level
of 60 dBA except as specified in subclause 201.9.6.2.1.103.
Compliance is checked by the following test:
With the microphone of a sound level meter complying with the requirements of IEC 61672-1
[5], positioned 100 mm to 150 mm above the centre of the INFANT tray, the measured sound
level shall not exceed the specified values. For this test the INFANT TRANSPORT INCUBATOR
shall be operated at a CONTROL TEMPERATURe of 36 °C and at a maximum humidity. The
background sound level measured inside the COMPARTMENT shall be at least 10 dBA below
that which is measured during the test.
201.9.6.2.1.102 * Audible alarms sound level
Auditory ALARM SIGNALS shall have a soun
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