EN IEC 60601-2-20:2020
(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 60601-2-20:2020 is available as IEC 60601-2-20:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-20:2020 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. HAZARDS 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, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-20:2020 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, see IEC 60601-2-35; - INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50. IEC 60601-2-20:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säglings-Tranportinkubatoren
Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés
IEC 60601-2-20:2020 est disponible sous forme de IEC 60601-2-20:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
Medicinska električna oprema - 2-20. del: Posebne zahteve za osnovno varnost in bistvene lastnosti prenosnih otroških inkubatorjev (IEC 60601-2-20:2020)
Ta del standarda IEC 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI opreme PRENOSNIH OTROŠKIH INKUBATORJEV, kot je določeno v točki 201.3.208, imenovanih tudi ELEKTROMEDICINSKA OPREMA.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri predvideni fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega dokumenta, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
OPOMBA: Glej tudi točko 4.2 splošnega standarda.
Ta standard določa varnostne zahteve za PRENOSNE OTROŠKE INKUBATORJE, vendar pa se alternativne metode skladnosti z določeno točko z dokazovanjem enake stopnje varnosti ne bodo štele za neskladne, če je PROIZVAJALEC v DOKUMENTACIJI O OBVLADOVANJU TVEGANJA dokazal, da je ugotovljeno TVEGANJE, ki ga predstavlja NEVARNOST, na sprejemljivi stopnji glede na koristi zdravljenja z napravo.
Ta standard se ne uporablja za:
– naprave, ki dovajajo toploto prek ODEJ, BLAZIN ali POSTELJNIH VLOŽKOV v medicinski uporabi, za informacije glej standard IEC 60601-2-35 [1]2;
– OTROŠKE INKUBATORJE, ki niso PRENOSNI OTROŠKI INKUBATORJI; za informacije glej standard IEC 60601-2-19 [2];
– OTROŠKE SEVALNE OGREVALNIKE; za informacije glej standard IEC 60601-2-21 [3];
– OTROŠKO FOTOTERAPEVTSKO OPREMO; za informacije glej standard IEC 60601-2-50 [4].
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2020
Nadomešča:
SIST EN 60601-2-20:2010
SIST EN 60601-2-20:2010/A1:2017
SIST EN 60601-2-20:2010/A11:2012
Medicinska električna oprema - 2-20. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti prenosnih otroških inkubatorjev (IEC 60601-2-20:2020)
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and
essential performance of infant transport incubators (IEC 60601-2-20:2020)
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Tranportinkubatoren (IEC 60601
-2-20:2020)
Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs de transport pour nouveau-nés (IEC
60601-2-20:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-20:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-20
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2020
ICS 11.040.10 Supersedes EN 60601-2-20:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-20: Particular requirements
for the basic safety and essential performance of infant transport
incubators
(IEC 60601-2-20:2020)
Appareils électromédicaux - Partie 2-20: Exigences Medizinische elektrische Geräte - Teil 2-20: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs de transport pour nouveau-nés wesentlichen Leistungsmerkmale von Tranportinkubatoren
(IEC 60601-2-20:2020) (IEC 60601-2-20:2020)
This European Standard was approved by CENELEC on 2020-10-07. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-20:2020 E
European foreword
The text of document 62D/1763/FDIS, future edition 3 of IEC 60601-2-20, prepared by SC 62D
“Electromedical equipment” of IEC/TC 62 “Electrical equipment in medical practice” was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-20:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-07-07
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-10-07
document have to be withdrawn
This document supersedes EN 60601-2-20:2009 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60601-2-20:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-2-19:2020 NOTE Harmonized as FprEN IEC 60601-2-19:2020 (not modified)
IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50
IEC 61672-1 NOTE Harmonized as EN 61672-1
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
Annex ZA of EN 60601-1:2006 applies, except as follows:
Addition:
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety
and essential performance
- - + corrigendum 2010
Mar.
+ A1 2012 + A1 2013
- - + A12 2014
ISO 32 - Gas cylinders for medical use; Marking - -
for identification of content
ISO 407 - - -
Replace:
IEC 60601-1-2 2014 Medical electrical equipment - Part 1–2: EN 60601-1-2 2015
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-2-20 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential performance
of infant transport incubators
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.10 ISBN 978-2-8322-8647-0
– 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 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 . 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 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 26
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 disturbances – Requirements and tests . 29
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
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
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
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
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
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
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
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 CLAUSE 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).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
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.
– 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.
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 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.
HAZARDS 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,
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
that the RISK presented by the HAZARD has been found to be of an
MANAGEMENT FILE
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] ;
– 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.
____________
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.
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.
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) 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 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.
KIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED TRANSPORT
S
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
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
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
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
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
TRANSPORT INCUBATOR TEMPERATURE does not vary by more than
condition reached when the
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
Key
M TRANSPORT 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 201.102 – 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
Clause 4 of the general standard applies, except as follows:
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
MANUFACTURER, details of which
be altered by such additional heat sources specified by the
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 * ESSENTIAL PERFORMANCE
Addition:
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 201.12.1.101, 201.12.1.102, 201.12.1.104
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
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 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 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 of the general standard)
Additional subclauses:
201.7.2.101 * Oxygen monitor
INFANT TRANSPORT INCUBATOR not equipped with an integral oxygen monitor and which
An
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:
– 14 – IEC 60601-2-20:2020 © IEC 2020
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.
INFANT TRANSPORT INCUBATOR should be used only by
a) * A statement that an
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 shall be taken to ensure that additional ME EQUIPMENT connected to
the INFANT is electrically safe.
ALARM SYSTEM.
h) An information on how and when to verify the functionality of the
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
use with the INFANT TRANSPORT INCUBATOR or as specified in the ACCOMPANYING
;
DOCUMENTS
– a statement that an oxygen analyser 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 201.12.1.107.
201.7.9.2.9 Operating instructions
Addition:
IEC 60601-2-20:2020 © IEC 2020 – 15 –
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 document;
– of how the INFANT's movements can be limited within the INFANT TRANSPORT INCUBATOR
during transport.
201.7.9.3 Technical description (see also Table C.6 of the general standard)
201.7.9.3.1 General
Additional item to the first paragraph:
– the maximum CO concentration (see 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:
201.9.2 MECHANICAL HAZARDS associated with moving parts
201.9.2.1 General
Addition:
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.
– 16 – IEC 60601-2-20:2020 © IEC 2020
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.
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:
IEC 60601-2-20:2020 © IEC 2020 – 17 –
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 dB(A) except as specified in 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
INCUBATOR shall be operated at a CONTROL TEMPERATURe of 36 °C and at a
TRANSPORT
maximum humidity. The background sound level measured inside the COM
...
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