SIST EN IEC 80601-2-59:2019

SLOVENSKI STANDARD
SIST EN IEC 80601-2-59:2019
01-december-2019
Nadomešča:
SIST EN 80601-2-59:2010
Medicinska električna oprema - 2-59. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti presejalnih termografov za spremljanje človekove temperature
pri mrzlici (IEC 80601-2-59:2017)
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and
essential performance of screening thermographs for human febrile temperature
screening (IEC 80601-2-59:2017)
Medizinische elektrische Geräte - Teil 2-59: Besondere Anforderungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Wärmebildkameras für
Reihenuntersuchungen von Menschen auf Fieber (IEC 80601-2-59:2017)
Appareils électromédicaux - Partie 2-59: Exigences particulières pour la sécurité de base
et les performances essentielles des imageurs thermiques pour le dépistage des
humains fébriles (IEC 80601-2-59:2017)
Ta slovenski standard je istoveten z: EN IEC 80601-2-59:2019
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 80601-2-59:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 80601-2-59:2019

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SIST EN IEC 80601-2-59:2019


EUROPEAN STANDARD EN IEC 80601-2-59

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2019
ICS 11.040.55 Supersedes EN 80601-2-59:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-59: Particular requirements
for the basic safety and essential performance of screening
thermographs for human febrile temperature screening
(IEC 80601-2-59:2017)
Appareils électromédicaux - Partie 2-59: Exigences Medizinische elektrische Geräte - Teil 2-59: Besondere
particulières pour la sécurité de base et les performances Anforderungen für die Sicherheit einschließlich der
essentielles des imageurs thermiques pour le dépistage des wesentlichen Leistungsmerkmale von Wärmebildkameras
humains fébriles für Reihenuntersuchungen von Menschen auf Fieber
(IEC 80601-2-59:2017) (IEC 80601-2-59:2017)
This European Standard was approved by CENELEC on 2017-10-24. 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 80601-2-59:2019 E

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SIST EN IEC 80601-2-59:2019
EN IEC 80601-2-59:2019 (E)
European foreword
The text of document 62D/1501/FDIS, future edition 2 of IEC 80601-2-59, 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 80601-2-59:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-04-11
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-10-11
document have to be withdrawn

This document supersedes EN 80601-2-59:2009.
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 80601-2-59:2017 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:
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10

2

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SIST EN IEC 80601-2-59:2019
EN IEC 80601-2-59:2019 (E)
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.
The Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement
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 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment_- Part_1-8: - -
General requirements for basic safety and
essential performance_- Collateral
standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems

Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
  +A12 2014
  +EN 60601-2010
1:2006/corrigendum
Mar. 2010
  +AC 2014
ISO/TR 13154 -  Medical electrical equipment -- - -
Deployment, implementation and
operational guidelines for indentifying
febrile humans using a screening
thermograph

3

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SIST EN IEC 80601-2-59:2019




IEC 80601-2-59


Edition 2.0 2017-09




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










Medical electrical equipment –

Part 2-59: Particular requirements for the basic safety and essential performance

of screening thermographs for human febrile temperature screening




Appareils électromédicaux –

Partie 2-59: Exigences particulières pour la sécurité de base et les performances


essentielles des imageurs thermiques pour le dépistage des humains fébriles













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.040.55 ISBN 978-2-8322-4815-7



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.

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CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions. 10
201.4 General requirements . 12
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 . 14
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 15
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16
201.15 Construction of ME EQUIPMENT . 16
201.16 ME SYSTEMS . 16
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16
201.101 LABORATORY ACCURACY of a SCREENING THERMOGRAPH . 17
201.102 SCREENING THERMOGRAPH ALARM CONDITIONS . 20
202 Electromagnetic disturbances – Requirements and tests . 21
206 USABILITY . 21
Annexes . 23
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 23
Annex AA (informative) Particular guidance and rationale . 25
Annex BB (normative) CALIBRATION SOURCE . 32
Annex CC (informative) Reference to the essential principles . 33
Bibliography . 36
Index of defined terms used in this document . 40

Figure AA.1 – Illustration of TARGET in the visible spectrum . 27
Figure AA.2 – Illustration of TARGET in the infrared spectrum . 27
Figure AA.3 – Relative drift of 4 DETECTORS as a function of time . 30

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 13
Table 201.C.101 – Marking on the outside of a SCREENING THERMOGRAPH or its parts . 23
Table 201.C.102 – ACCOMPANYING DOCUMENTS, general of a SCREENING THERMOGRAPH . 23
Table 201.C.103 – ACCOMPANYING DOCUMENTS, instructions for use of a SCREENING
THERMOGRAPH . 24

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Table 201.C.104 – ACCOMPANYING DOCUMENTS, technical description of a SCREENING
THERMOGRAPH . 24
Table AA.1 – Example of relevant uncertainty terms for a SCREENING THERMOGRAPH . 28
Table CC.1 – Correspondence between this document and the essential principles . 33

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-59: Particular requirements for the basic safety
and essential performance of screening thermographs
for human febrile temperature screening

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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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 80601-2-59 has been prepared by a Joint Working Group of IEC
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and of ISO subcommittee SC3: Lung ventilators and related
equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
This second edition cancels and replaces the first edition published in 2008. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) updates of the normative references and the bibliography;
b) expansion of the applicability to pandemic infectious diseases in general.

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IEC 80601-2-59:2017  IEC 2017 – 5 –
The text of this document is based on the following documents:
FDIS Report on voting
62D/1501/FDIS 62D/1515/RVD

Full information on the voting for the approval of this document 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 DOCUMENT 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 document 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.

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The committee has decided that the contents of this publication 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.
NOTE The attention of National Committees and Member Bodies 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 or ISO 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 committees that the content of this
publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.

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IEC 80601-2-59:2017  IEC 2017 – 7 –
INTRODUCTION
The minimum safety requirements specified in this document are considered to provide for a
practical degree of safety in the operation of ME EQUIPMENT for human febrile temperature
screening.
This document describes ME EQUIPMENT that uses infrared technology to detect naturally
emitted heat at the skin surface of the FACE. Such ME EQUIPMENT can be useful at ports-of-
entry or ports-of-exit and the entrances to buildings under controlled environmental conditions
to separate febrile from afebrile individuals to help prevent the spread of communicable
diseases. Care can be needed when evaluating individuals under changing environmental
conditions, but the region medially adjacent to the inner canthus of the eye has been
demonstrated to be a robust measurement site and is supplied by the internal carotid artery.
1
[1]
A body core temperature of 38 °C or above was used as the criterion to restrict traveling
during the SARS (severe acute respiratory syndrome) epidemic (April 2003). [2] The US
Centers for Disease Control advises that SARS typically begins with a temperature above
38 °C, which is 1 °C higher than normal human body core temperature which averages around
37 °C. [3] It is hard to give an accurate assessment of how many people were checked by
infrared temperature measurements in China during the SARS epidemic. There is official
Chinese government data indicating that during a two-month period in the spring of 2003, 30
million travellers were screened in China. From this cohort, 9 292 travellers with elevated
temperature were detected and 38 were suspected of being SARS carriers. SARS was
diagnosed in 21 of these cases. All elevated temperatures were confirmed using traditional
clinical temperature measurements of body temperature. Although it is hard to determine the
human body's core temperature accurately by infrared measurement of SKIN TEMPERATURE, it
can be used for screening for elevated temperature values. [2] [4] [5] Improved rates of
detection may result from improved techniques.[6]
International travellers were screened during the 2009 H1N1 influenza outbreak. [7] [8] The
pandemic potential of other influenzas such as H7N9 [9] is of concern to the World Health
Organization (WHO). [10]
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) was first reported in Saudi
Arabia in 2012, and a total of 1 026 laboratory-confirmed cases resulting in at least 376
deaths (36,7%) have been confirmed by the World Health Organization (WHO) as of 25
February 2015. [11] Most identified cases have had fever, although some mild and/or
asymptomatic cases have been reported. [11] [12] [13] [14] The possibility of widespread
dissemination of MERS-CoV during religious pilgrimage [11] and other regional travel has
been investigated, but appears to be under control [15], although WHO continues to express
concern. [13] [14] Fever screening at airports has also been employed during outbreaks of
Dengue in Taiwan. [16] [17]
The 2014 Ebola outbreak originating in West Africa has brought issues of the potential for
global pandemic to the forefront. [18] [19] [20] [21] Controversy has arisen over the
effectiveness of thermography for fever screening at airports and other checkpoints [22] [23],
while empirical data has demonstrated the effectiveness of this technology when used in
compliance with appropriate international standards [24] [25] [26] [27] and WHO guidance.
[10] [20] [21]
This document is intended to be applicable for thermographic fever screening devices for the
above-mentioned and any other fever-producing infectious diseases. [10] [15] [28] [29].

_____________
1
 Figures in square brackets refer to the Bibliography

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MEDICAL ELECTRICAL EQUIPMENT –

Part 2-59: Particular requirements for the basic safety
and essential performance of screening thermographs
for human febrile temperature screening



201.1 Scope, object and related standards
2
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING
THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature
screening of a human under controlled environmental conditions, hereafter referred to as
ME EQUIPMENT. This document sets laboratory characterization test limits for the SCREENING
THERMOGRAPH.
NOTE 101 A SCREENING THERMOGRAPH is intended for screening of a human subject and detection of SKIN
TEMPERATURE elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent
temperature measurement using a clinical thermometer (see ISO 80601-2-56 [30]).
NOTE 102 The main part of such equipment is commonly referred to as an infrared camera.
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.
201.1.2 Object
Replacement:
The object of this particular document is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for SCREENING THERMOGRAPHS as defined in 201.3.209.
201.1.3 Collateral standards
Addition:
This particular document refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this document.
IEC 60601-1-2:2014, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 apply as
modified in Clauses 202 and 206 respectively. IEC 60601-1-3, IEC 60601-1-10, IEC 60601-1-
11 and IEC 60601-1-12 do not apply. All other published collateral standards in the
IEC 60601-1 series apply as published.
_____________
2
 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

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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 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this
particular document as the general standard. Collateral standards are referred to by their
document number.
The numbering of clauses and subclauses of this document 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 document
addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this
document addresses the content of Clause 4 of the IEC 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 document.
"Addition" means that the text of this document 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 document.
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.
Subclaus
...