IEC 80601-2-59:2017

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

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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

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
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