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
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.
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Standards Content (Sample)
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
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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
...
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