IEC 80601-2-59:2008

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

IEC 80601-2-59:2008 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of humans under indoor environmental conditions. IEC 80601-2-59:2008 sets laboratory characterization test limits for the screening thermograph. The contents of the corrigendum of April 2009 have been included in this copy.

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

La CEI 80601-2-59:2008 s'applique à la sécurite de base et aux performances essentielles des imageurs thermiques destinés à être utilisés pour le dépistage non invasif des humains fébriles parmi des individus dans des conditions d'environnement à l'intérieur. La CEI 80601-2-59:2008 fixe des limites d'essais de caractérisation en laboratoire pour les imageurs thermiques. Le contenu du corrigendum d'avril 2009 a été pris en considération dans cet exemplaire.

General Information

• Status: Published
• Publication Date: 20-Oct-2008
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 19-Sep-2017

Relations

• Corrected By: IEC 80601-2-59:2008/COR1:2009 - Corrigendum 1 - 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: 05-Sep-2023
• Revised: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 80601-2-59
Edition 1.0 2008-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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 1.0 2008-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
PRICE CODE
INTERNATIONALE
V
CODE PRIX
ICS 11.040.55 ISBN 978-2-88910-784-1

– 2 – 80601-2-59 © IEC:2008
CONTENTS
FOREWORD.3
INTRODUCTION.5
201.1 Scope, object and related standards.6
201.2 Normative references.7
201.3 Terms and definitions .8
201.4 General requirements.10
201.5 General requirements for testing of ME EQUIPMENT .10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents .11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .11
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS .12
201.10 Protection against unwanted and excessive radiation HAZARDS .12
201.11 Protection against excessive temperatures and other HAZARDS .12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .12
201.13 HAZARDOUS SITUATIONS and fault conditions .13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .13
201.15 Construction of ME EQUIPMENT.13
201.16 ME SYSTEMS.13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .13
201.101 Laboratory accuracy of a screening thermograph.14
201.102 Screening thermograph alarm conditions .17
Annexes .18
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.18
Annex AA (informative) Particular guidance and rationale.20
Annex BB (normative) CALIBRATION SOURCE .26
Annex CC (informative) Reference to the essential principles .27
Bibliography.29
Index of defined terms used in this particular standard.34

Figure AA.1 – Relative drift of 4 DETECTORS as a function of time.24

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements .10
Table 201.C.101 – ACCOMPANYING DOCUMENTS, instructions for use of a SCREENING
THERMOGRAPH .18
Table 201.C.102 – ACCOMPANYING DOCUMENTS, technical description of a SCREENING
THERMOGRAPH .19
Table AA.1 – Example of relevant uncertainty terms for a SCREENING THERMOGRAPH .22
Table CC.1 – Correspondence between this particular standard and the essential
principles .27

80601-2-59 © IEC:2008 – 3 –
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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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.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/697/FDIS 62D/720/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table. In ISO, the standard has been approved by
12 P-members out of 15 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

– 4 – 80601-2-59 © IEC:2008
In this standard, 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.
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NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause
...