SIST EN IEC 80601-2-59:2019
(Main)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)
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)
IEC 80601-2-59:2017 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.
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.
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)
L'IEC 80601-2-59:2017 s’applique à la sécurité de base et aux performances essentielles des imageurs thermiques destinés à être utilisés pour le dépistage non invasif d’un humain fébrile parmi des individus dans des conditions environnementales contrôlées, appelés appareils EM dans la suite du texte. Le présent document fixe des limites d’essais de caractérisation en laboratoire pour les imageurs thermiques.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) mise à jour des références normatives et de la bibliographie;
b) plus grande applicabilité de la norme aux maladies infectieuses pandémiques.
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)
Ta del standarda IEC 80601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI PRESEJALNIH TERMOGRAFOV, ki so namenjeni uporabi za posamezno neinvazivno spremljanje človekove temperature pri mrzlici pod nadzorovanimi okoljskimi pogoji (v nadaljevanju »ELEKTROMEDICINSKA OPREMA«). Ta dokument določa mejne vrednosti preskusa laboratorijskih lastnosti za PRESEJALNI TERMOGRAF. OPOMBA 101: PRESEJALNI TERMOGRAF je namenjen spremljanju in zaznavanju človekove povišane TEMPERATURE KOŽE. Povišano TEMPERATURO KOŽE je treba spremljati z nadaljnjim merjenjem temperature s kliničnim termometrom (glej standard ISO 80601-2-56 [30]). OPOMBA 102: Glavni del takšne opreme se običajno imenuje infrardeča kamera. 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.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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
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
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
– 2 – IEC 80601-2-59:2017 IEC 2017
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
IEC 80601-2-59:2017 IEC 2017 – 3 –
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
– 4 – IEC 80601-2-59:2017 IEC 2017
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.
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.
– 6 – IEC 80601-2-59:2017 IEC 2017
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.
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]
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].
_____________
Figures in square brackets refer to the Bibliography
– 8 – IEC 80601-2-59:2017 IEC 2017
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
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.
_____________
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
IEC 80601-2-59:2017 IEC 2017 – 9 –
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.
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 document taken together.
Where there is no corresponding clause or subclause in this document, 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 document.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
– 10 – IEC 80601-2-59:2017 IEC 2017
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
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
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
IEC 60601-1-8:2006/AMD1:2012
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/TR 13154, Medical electrical equipment – Deployment, implementation and operational
guidelines for identifying febrile humans using a screening thermograph
ASTM E1213-14 , Standard Test Method for Minimum Resolvable Temperature Difference for
Thermal Imaging Systems
201.3 Terms and definitions
For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005
and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/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 40.
Addition:
201.3.201
CALIBRATION
set of operations that establish, under specified conditions, the relationship between values of
quantities indicated by a measuring instrument, or measuring system, or values represented
by a material measure or a reference material and the corresponding values realized by
standards
_____________
ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA, 19428-2959 USA or
https://www.astm.org/
IEC 80601-2-59:2017 IEC 2017 – 11 –
201.3.202
CALIBRATION SOURCE
infrared radiation blackbody reference source of known and traceable temperature and
EMISSIVITY
201.3.203
DETECTOR
infrared thermal sensor or array of sensors able to detect infrared thermal energy radiating
from the surface of the FACE or other object
Note 1 to entry: The DETECTOR responds to the net infrared radiation and converts that response into electrical
signals.
201.3.204
EMISSIVITY
ratio of the emitted thermal rate of propagation of electromagnetic energy emitted by an
object as a consequence of its temperature propagated in a given direction, per unit solid
angle about that direction and per unit area projected normal to the direction of a surface to
that of a ideal blackbody at the same temperature and under the same spectral conditions
Note 1 to entry: The EMISSIVITY of wet or dry human skin is accepted to be 0,98. [31] [32]
Note 2 to entry: The properties of an ideal blackbody are described by Planck’s Law.
201.3.205
EXTERNAL TEMPERATURE REFERENCE SOURCE
part of the SCREENING THERMOGRAPH that is used to ensure accurate operation between
CALIBRATIONS using an infrared radiation source of known temperature and EMISSIVITY
Note 1 to entry: The EXTERNAL TEMPERATURE REFERENCE SOURCE is normally imaged in each thermogram of the
FACE or prior to each thermogram of the FACE.
201.3.206
FACE
anterior cranial face of the PATIENT being measured
201.3.207
IMAGE PIXEL
individual infrared thermal detections from the DETECTOR
Note 1 to entry: The number of IMAGE PIXELS is given in an array format. e.g. number of sensors in horizontal (H)
by number of sensors in vertical (V) e.g. for a 120 (H) x 120 (V) DETECTOR array, the number of IMAGE PIXELS would
be 14 400.
201.3.208
LABORATORY ACCURACY
closeness of the agreement between the result of a measurement (with SCREENING
THERMOGRAPH) and the true value of the measurand
Note 1 to entry: LABORATORY ACCURACY is a qualitative concept. For a quantitative description, the term
'uncertainty’ should be used.
201.3.209
SCREENING THERMOGRAPH
ME EQUIPMENT or ME SYSTEM that:
– detects infrared radiation emitted from the FACE from which a thermogram is obtained from
the TARGET;
EXTERNAL TEMPERATURE REFERENCE SOURCE;
– detects infrared radiation emitted from an
– 12 – IEC 80601-2-59:2017 IEC 2017
– displays a radiometric thermal image;
– obtains a temperature reading from the TARGET; and
– compares that temperature reading to the THRESHOLD TEMPERATURE to determine if the
PATIENT is febrile
Note 1 to entry: A SCREENING THERMOGRAPH is a non-contact, non-invasive, non-ionizing temperature screening
ME EQUIPMENT used to measure the FACE temperature and indicate the screened region with a different colour if the
temperature is above the THRESHOLD TEMPERATURE setting. Such a device is commonly referred to as an infrared
camera.
Note 2 to entry: A SCREENING THERMOGRAPH has to identify the TARGET from the thermogram to obtain the TARGET
temperature reading.
201.3.210
SELF-CORRECTION
automatic process carried out to compensate for DETECTOR drift
EXAMPLE To reduce the error caused by possible drift, the SCREENING THERMOGRAPH carries out a SELF-
CORRECTION.
Note 1 to entry: An uncooled microbolometer DETECTOR can be subject to significant drift in its measurements
over time.
201.3.211
SKIN TEMPERATURE
skin surface temperature as measured from the WORKABLE TARGET PLANE of a SCREENING
THERMOGRAPH, with an appropriate adjustment for skin EMISSIVITY
Note 1 to entry: The EMISSIVITY of wet or dry human skin is accepted to be 0,98. [31] [32]
201.3.212
TARGET
region of the FACE selected for THRESHOLD TEMPERATURE comparison
201.3.213
TARGET PLANE
in-focus plane perpendicular to the central axis of the field of view of the infrared camera of a
SCREENING THERMOGRAPH
201.3.214
THRESHOLD TEMPERATURE
temperature setting, above which the SCREENING THERMOGRAPH indicates that the TARGET is
potentially febrile
Note 1 to entry: This is typically indicated in degrees Celsius.
201.3.215
WORKABLE TARGET PLANE
region of TARGET PLANE that meets the specified performance requirements
Note 1 to entry: The WORKABLE TARGET PLANE can be the whole or part of the TARGET PLANE.
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 at the end of the subclause:
IEC 80601-2-59:2017 IEC 2017 – 13 –
When applying this document to a SCREENING THERMOGRAPH, definitions and requirements that
use the term PATIENT shall be considered as applying to the person being screened for a
febrile state.
201.4.3 ESSENTIAL PERFORMANCE
Addition:
Table 201.101 summarizes the ESSENTIAL PERFORMANCE requirements of this document.
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Minimum radiometric temperature LABORATORY ACCURACY of the SCREENING 201.101.2.2
THERMOGRAPH
THRESHOLD TEMPERATURE and the resulting ALARM CONDITION 201.101.2.3
201.102.2
Start-up TECHNICAL ALARM CONDITION 201.102.1
NOTE Failure to indicate that the SCREENING THERMOGRAPH is not capable of performing to
specification is considered a loss of ESSENTIAL PERFORMANCE.
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 at end of a):
The range of environmental conditions for NORMAL USE shall include:
– a temperature range of 18 °C to 24 °C;
– a relative humidity range of 10 % to 75 %.
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:
201.7.2.2 Identification
Replacement of the first dash by:
– the name or trade name and address of the following:
• the MANUFACTURER;
• where the MANUFACTURER does not have an address within the locale, an authorized
representative within the locale,
to which the RESPONSIBLE ORGANIZATION can refer;
– 14 – IEC 80601-2-59:2017 IEC 2017
201.7.9.1 General
Replacement of the first dash by:
– name or trade name and address of the following:
• the MANUFACTURER;
• where the MANUFACTURER does not have an address within the locale, an authorized
representative within the locale,
to which the RESPONSIBLE ORGANIZATION can refer;
201.7.9.2.9 * Operating instructions
Addition at the end of the subclause:
The instructions for use shall include the following.
a) * Instruction to the OPERATOR to ensure that the FACE is unobstructed by hair, eyeglasses,
and other objects because their presence will interfere with the ability of a SCREENING
THERMOGRAPH to detect a febrile condition. Disclose the recommended position of the
FACE required to obtain the TARGET relative to the optical pathway of the SCREENING
THERMOGRAPH.
EXAMPLE Position of the FACE relative to the lens of the infrared camera.
b) Recommendation to the OPERATOR to perform a secondary screening with a clinical
thermometer of any individual that the SCREENING THERMOGRAPH indicates is possibly
febrile.
201.7.9.3.1 * General
Addition to the first dash:
A recommendation that the relative humidity in the area of screening should be maintained
below 50 % and the temperature below 24 °C to achieve the INTENDED USE and an
explanation of the effects of elevated humidity and ambient temperature on the
temperature reading caused by sweating.
NOTE 101 The measurements provided by a SCREENING THERMOGRAPH in INTENDED USE can be influenced
when the PATIENT is sweating. Sweating thresholds can vary, according to a person's fitness level, environment
of residence, length of adaptation and the relative humidity. [33]
Addition as the last four dashes:
– a reference to ISO/TR 13154 including its title.
– an explanation of the effects due to environmental infrared sources such as sunlight,
nearby electrical sources and lighting, and instructions that these should be minimized.
– an explanation of the effects due to airflow, and instructions that this should be minimized.
– a description of the TARGET.
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.
IEC 80601-2-59:2017 IEC 2017 – 15 –
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.2 USABILITY of ME EQUIPMENT
Additional subclauses:
201.12.2.101 Display
201.12.2.101.1 * Display colour scale
The SCREENING THERMOGRAPH shall be provided with an isothermal colour display for visual
interpretation and rapid identification of the thermogram of the WORKABLE TARGET PLANE. The
indication of temperature range, with colour code/temperature scale, shall be displayed. The
SCREENING THERMOGRAPH shall be provided with at least one colour mapping mode where the
colours follow the order of the visible spectrum (e.g., rainbow scale) such that blue is cooler
and red is hotter.
Compliance is checked by inspection.
201.12.2.101.2 Display temperature resolution
The temperature increment displayed in a thermal image of the SCREENING THERMOGRAPH
should not exceed 0,1 °C.
NOTE This is typically indicated in degrees Celsius.
Compliance is checked by inspection.
201.12.2.102 * Response time and throughput
The SCREENING THERMOGRAPH should be capable of operating in near real-time for rapid and
effective screening of a mass population. The MANUFACTURER shall estimate the throughput
(time between measurements) in NORMAL USE of the SCREENING THERMOGRAPH. The average
time required by a SCREENING THERMOGRAPH to measure, process and display the temperature
of the FACE and throughput of the SCREENING THERMOGRAPH shall be disclosed in the technical
description.
Compliance is checked by functional testing and inspection of the instructions for use.
201.12.2.103 * WORKABLE TARGET PLANE
The minimum display of the WORKABLE TARGET PLANE shall be 320 IMAGE PIXELS by 240 IMAGE
PIXELS. In NORMAL USE, the thermogram of the FACE shall fill at least 240 IMAGE PIXELS by 180
IMAGE PIXELS. The WORKABLE TARGET PLANE should be parallel to the FACE to improve
performance. [34] If the SCREENING THERMOGRAPH requires that the OPERATOR frame the
thermogram of the FACE in the WORKABLE TARGET PLANE, a guide or mask shall be provided in
the image of the WORKABLE TARGET PLANE on the display. [34]
– 16 – IEC 80601-2-59:2017 IEC 2017
NOTE 240 IMAGE PIXELS by 180 IMAGE PIXELS is 56 % of the minimum display of the WORKABLE TARGET PLANE.
The size or coordinates of the WORKABLE TARGET PLANE, if it is smaller than the SCREENING
THERMOGRAPH'S TARGET PLANE, shall be di
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