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.

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

L'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.
L'IEC 60601-2-20:2020 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des INCUBATEURS DE TRANSPORT POUR NOUVEAU-NES, tels que définis au 201.3.208, également désignés sous le terme APPAREILS EM.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas.
Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 7.2.13 et de 8.4.1 de la norme générale.
La présente norme particulière spécifie les exigences de sécurité relatives aux INCUBATEURS DE TRANSPORT POUR NOUVEAU-NES, mais des méthodes alternatives de conformité à un article spécifique, en démontrant un niveau équivalent de sécurité, ne sont pas considérées comme non conformes, si le FABRICANT a démontré dans son DOSSIER DE GESTION DES RISQUES que le RISQUE présenté par le DANGER s'est révélé avoir un niveau acceptable, lorsqu'il a été évalué par rapport aux avantages du traitement présentés par le dispositif.
La présente norme particulière ne s'applique pas aux:
– dispositifs délivrant de la chaleur par l'intermédiaire de COUVERTURES, COUSSINS ou MATELAS en usage médical; voir l'IEC 60601-2-35 à titre informatif;
– INCUBATEURS POUR NOUVEAU-NES qui ne sont pas des INCUBATEURS DE TRANSPORT POUR NOUVEAU-NES; voir l'IEC 60601-2-19 à titre informatif;
– INCUBATEURS RADIANTS POUR NOUVEAU-NES, voir l'IEC 60601-2-21 à titre informatif;
– APPAREILS DE PHOTOTHERAPIE POUR NOUVEAU-NES, voir l'IEC 60601-2-50 à titre informatif.
L'IEC 60601-2-20:2020 annule et remplace la deuxième édition parue en 2009 et l'Amendement 1:2016. Cette édition constitue une révision technique.
Cette édition inclut la modification technique majeure suivante par rapport à l'édition précédente: nouvelle datation des références normatives.

General Information

Status

Published

Publication Date

01-Sep-2020

ICS

01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION

11.040.10 - Anaesthetic, respiratory and reanimation equipment

Technical Committee

SC 62D - Electromedical equipment

Current Stage

PPUB - Publication issued

Completion Date

02-Sep-2020

Ref Project

Buy Standard

IEC 60601-2-20:2020 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

Standard

IEC 60601-2-20:2020 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

English language

44 pages

sale 15% off

Preview

sale 15% off

Preview

Standard

IEC 60601-2-20:2020 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

English and French language

92 pages

sale 15% off

Preview

sale 15% off

Preview

Standards Content (sample)

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
IEC 60601-2-20:2020-09(en)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2020 IEC, Geneva, Switzerland

or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from

either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC

your local IEC member National Committee for further information.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC

The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes

International Standards for all electrical, electronic and related technologies.
About IEC publications

The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the

latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org

The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,

variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English

committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.

and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished

Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary

details all new publications released. Available online and once 67 000 electrotechnical terminology entries in English and

a month by email. French extracted from the Terms and Definitions clause of IEC
publications issued since 2002. Some entries have been

IEC Customer Service Centre - webstore.iec.ch/csc collected from earlier publications of IEC TC 37, 77, 86 and

If you wish to give us your feedback on this publication or need CISPR.
further assistance, please contact the Customer Service
Centre: sales@iec.ch.
---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

® Registered trademark of the International Electrotechnical Commission
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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.
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
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.
---------------------- Page: 7 ----------------------
– 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.

---------------------- Page: 8 ----------------------
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.
---------------------- Page: 9 ----------------------
– 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.
---------------------- Page: 10 ----------------------
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

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
---------------------- Page: 11 ----------------------
– 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
---------------------- Page: 12 ----------------------
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.
---------------------- Page: 13 ----------------------
– 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.
---------------------- Page: 14 ----------------------
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:
...

IEC 60601-2-20
Edition 3.0 2020-09
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
IEC 60601-2-20:2020-09(en-fr)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2020 IEC, Geneva, Switzerland

or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from

either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC

your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite

ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie

et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des

questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez

les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC

The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes

International Standards for all electrical, electronic and related technologies.
About IEC publications

The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the

latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC online collection - oc.iec.ch

The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the

variety of criteria (reference number, text, technical publications previews. With a subscription you will always

committee, …). It also gives information on projects, replaced have access to up to date content tailored to your needs.

and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 000 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 18 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC

La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des

Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC

Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la

plus récente, un corrigendum ou amendement peut avoir été publié.
Recherche de publications IEC - IEC online collection - oc.iec.ch

webstore.iec.ch/advsearchform Découvrez notre puissant moteur de recherche et consultez

La recherche avancée permet de trouver des publications IEC gratuitement tous les aperçus des publications. Avec un

en utilisant différents critères (numéro de référence, texte, abonnement, vous aurez toujours accès à un contenu à jour

comité d’études, …). Elle donne aussi des informations sur adapté à vos besoins.
les projets et les publications remplacées ou retirées.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
Le premier dictionnaire d'électrotechnologie en ligne au
Restez informé sur les nouvelles publications IEC. Just
monde, avec plus de 22 000 articles terminologiques en
Published détaille les nouvelles publications parues.
anglais et en français, ainsi que les termes équivalents dans
Disponible en ligne et une fois par mois par email.
16 langues additionnelles. Egalement appelé Vocabulaire
Electrotechnique International (IEV) en ligne.
Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
sales@iec.ch.
---------------------- Page: 2 ----------------------
IEC 60601-2-20
Edition 3.0 2020-09
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
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-9981-4

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 60601-2-20:2020 © IEC 2020
CONTENTS