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 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.
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English
CONTENTS
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT andME SYSTEMS
201.10 Protection against unwanted and excessive radiation HAZARDS
201.11 Protection against excessive temperatures and other HAZARDS
201.12 Accuracy of controls and instruments and protection againsthazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
201.101 LABORATORY ACCURACY of a SCREENING THERMOGRAPH
201.102 SCREENING THERMOGRAPH ALARM CONDITIONS
202 Electromagnetic disturbances – Requirements and tests
206 USABILITY
Annexes
Annex C(informative)Guide to marking and labelling requirementsfor me equipment and me systems
Annex AA(informative)Particular guidance and rationale
Annex BB(normative)Calibration source
Annex CC(informative)Reference to the essential principles
Bibliography
Index of defined terms used in this document
Figures
Figure AA.1 – Illustration of target in the visible spectrum
Figure AA.2 – Illustration of target in the infrared spectrum
Figure AA.3 – Relative drift of 4 detectors as a function of time
Tables
Table 201.101 – Distributed essential performance requirements
Table 201.C.101 – Marking on the outside of a screening thermograph or its parts
Table 201.C.102 – Accompanying documents, general of a screening thermograph
Table 201.C.103 – Accompanying documents, instructions for use of a screening thermograph
Table 201.C.104 – Accompanying documents, technical description of a screening thermograph
Table AA.1 – Example of relevant uncertainty terms for a screening thermograph
Table CC.1 – Correspondence between this documentand the essential principles (1 of 3)
Français
SOMMAIRE
AVANT-PROPOS
INTRODUCTION
201.1 Domaine d'application, objet et normes connexes
201.2 Références normatives
201.3 Termes et définitions
201.4 Exigences générales
201.5 Exigences générales relatives aux essais des APPAREILS EM
201.6 Classification des APPAREILS EM et des SYSTEMES EM
201.7 Identification, marquage et documentation des APPAREILS EM
201.8 Protection contre les DANGERS d'origine électrique provenant desAPPAREILS EM
201.9 Protection contre les DANGERS mécaniques des APPAREILS EM etSYSTEMES EM
201.10 Protection contre les DANGERS dus aux rayonnements involontairesou excessifs
201.11 Protection contre les températures excessives et les autres DANGERS
201.12 Précision des commandes, des instruments et protection contre lescaractéristiques de sortie présentant des risques
201.13 SITUATIONS DANGEREUSES et conditions de défaut pour les APPAREILS EM
201.14 SYSTEMES ELECTROMEDICAUX PROGRAMMABLES (SEMP)
201.15 Construction de l’APPAREIL EM
201.16 SYSTEMES EM
201.17 Compatibilité électromagnétique des APPAREILS et des SYSTEMES EM
201.101 EXACTITUDE DE LABORATOIRE d’un IMAGEUR THERMIQUE
201.102 CONDITIONS D’ALARME DE L’IMAGEUR THERMIQUE
202 Perturbations électromagnétiques – Exigences et essais
206 APTITUDE A L’UTILISATION
Annexes
Annexe C(informative)Guide pour le marquage et exigences d'étiquetagepour les appareils em et les systèmes em
Annexe AA (informative)Guide particulier et justifications
Annexe BB (normative)Source d’étalonnage
Annexe CC (informative)Référence aux principes essentiels
Bibliographie
Index des termes définis utilisés dans le présent document
Figures
Figure AA.1 – Représentation de la cible dans le spectre visible
Figure AA.2 – Représentation de la cible dans le spectre infrarouge
Figure AA.3 – Dérive relative de 4 détecteurs en fonction du temps
Tableaux
Tableau 201.101 – Répartition des exigences de performances essentielles
Tableau 201.C.101 – Marquage à l'extérieur d’un imageur thermique ou de ses parties
Tableau 201.C.102 – Documents d’accompagnementd’un imageur thermique – généralités
Tableau 201.C.103 – Documents d’accompagnement,instruction d’utilisation d’un imageur thermique
Tableau 201.C.104 – Documents d’accompagnement,description technique d’un imageur thermique
Tableau AA.1 – Exemple de termes d’incertitude appropriés à un imageur thermique
Tableau CC.1 – Correspondance entre le présent documentet les principes essentiels (1 de 3)
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English
CONTENTS
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT andME SYSTEMS
201.10 Protection against unwanted and excessive radiation HAZARDS
201.11 Protection against excessive temperatures and other HAZARDS
201.12 Accuracy of controls and instruments and protection againsthazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
201.101 LABORATORY ACCURACY of a SCREENING THERMOGRAPH
201.102 SCREENING THERMOGRAPH ALARM CONDITIONS
202 Electromagnetic disturbances – Requirements and tests
206 USABILITY
Annexes
Annex C(informative)Guide to marking and labelling requirementsfor me equipment and me systems
Annex AA(informative)Particular guidance and rationale
Annex BB(normative)Calibration source
Annex CC(informative)Reference to the essential principles
Bibliography
Index of defined terms used in this document
Figures
Figure AA.1 – Illustration of target in the visible spectrum
Figure AA.2 – Illustration of target in the infrared spectrum
Figure AA.3 – Relative drift of 4 detectors as a function of time
Tables
Table 201.101 – Distributed essential performance requirements
Table 201.C.101 – Marking on the outside of a screening thermograph or its parts
Table 201.C.102 – Accompanying documents, general of a screening thermograph
Table 201.C.103 – Accompanying documents, instructions for use of a screening thermograph
Table 201.C.104 – Accompanying documents, technical description of a screening thermograph
Table AA.1 – Example of relevant uncertainty terms for a screening thermograph
Table CC.1 – Correspondence between this documentand the essential principles (1 of 3)
Français
SOMMAIRE
AVANT-PROPOS
INTRODUCTION
201.1 Domaine d'application, objet et normes connexes
201.2 Références normatives
201.3 Termes et définitions
201.4 Exigences générales
201.5 Exigences générales relatives aux essais des APPAREILS EM
201.6 Classification des APPAREILS EM et des SYSTEMES EM
201.7 Identification, marquage et documentation des APPAREILS EM
201.8 Protection contre les DANGERS d'origine électrique provenant desAPPAREILS EM
201.9 Protection contre les DANGERS mécaniques des APPAREILS EM etSYSTEMES EM
201.10 Protection contre les DANGERS dus aux rayonnements involontairesou excessifs
201.11 Protection contre les températures excessives et les autres DANGERS
201.12 Précision des commandes, des instruments et protection contre lescaractéristiques de sortie présentant des risques
201.13 SITUATIONS DANGEREUSES et conditions de défaut pour les APPAREILS EM
201.14 SYSTEMES ELECTROMEDICAUX PROGRAMMABLES (SEMP)
201.15 Construction de l’APPAREIL EM
201.16 SYSTEMES EM
201.17 Compatibilité électromagnétique des APPAREILS et des SYSTEMES EM
201.101 EXACTITUDE DE LABORATOIRE d’un IMAGEUR THERMIQUE
201.102 CONDITIONS D’ALARME DE L’IMAGEUR THERMIQUE
202 Perturbations électromagnétiques – Exigences et essais
206 APTITUDE A L’UTILISATION
Annexes
Annexe C(informative)Guide pour le marquage et exigences d'étiquetagepour les appareils em et les systèmes em
Annexe AA (informative)Guide particulier et justifications
Annexe BB (normative)Source d’étalonnage
Annexe CC (informative)Référence aux principes essentiels
Bibliographie
Index des termes définis utilisés dans le présent document
Figures
Figure AA.1 – Représentation de la cible dans le spectre visible
Figure AA.2 – Représentation de la cible dans le spectre infrarouge
Figure AA.3 – Dérive relative de 4 détecteurs en fonction du temps
Tableaux
Tableau 201.101 – Répartition des exigences de performances essentielles
Tableau 201.C.101 – Marquage à l'extérieur d’un imageur thermique ou de ses parties
Tableau 201.C.102 – Documents d’accompagnementd’un imageur thermique – généralités
Tableau 201.C.103 – Documents d’accompagnement,instruction d’utilisation d’un imageur thermique
Tableau 201.C.104 – Documents d’accompagnement,description technique d’un imageur thermique
Tableau AA.1 – Exemple de termes d’incertitude appropriés à un imageur thermique
Tableau CC.1 – Correspondance entre le présent documentet les principes essentiels (1 de 3)