EN IEC 80601-2-59:2019

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 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

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

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

• Status: Published
• Publication Date: 10-Oct-2019
• Withdrawal Date: 10-Oct-2022
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 11-Oct-2019
• Completion Date: 11-Oct-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN IEC 80601-2-59:2019 - 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)

Relations

• Replaces: EN 80601-2-59:2009 - Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
• Effective Date: 23-Jan-2023
• Amended By: EN IEC 80601-2-59:2019/A1:2023 - Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
• Effective Date: 03-Aug-2021

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 poss
...