EN 80601-2-59:2009

SLOVENSKI STANDARD
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Medical electrical equipment - Part 2-59: Particular requirements for basic safety and
essential performance of screening thermographs for human febrile temperature
screening (IEC 80601-2-59:2008 + corrigendum Apr. 2009)
Medizinische elektrische Geräte - Teil 2-59: Besondere Anforderungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Wärembildkameras für
Reihenuntersuchungen von Menschen auf Fieber (IEC 80601-2-59:2008 + corrigendum
Apr. 2009)
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 (CEI 80601-2-59:2008 + corrigendum Apr. 2009)
Ta slovenski standard je istoveten z: EN 80601-2-59:2009
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 80601-2-59
NORME EUROPÉENNE
December 2009
EUROPÄISCHE NORM
ICS 11.040.55
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 80601-2-59:2008 + corrigendum 2009)

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-59: Exigences particulières Teil 2-59: Besondere Anforderungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des imageurs thermiques von Wärmebildkameras
pour le dépistage des humains fébriles für Reihenuntersuchungen
(CEI 80601-2-59:2008 von Menschen auf Fieber
+ corrigendum 2009) (IEC 80601-2-59:2008
+ Corrigendum 2009)
This European Standard was approved by CENELEC on 2009-11-17. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 80601-2-59:2009 E
Foreword
The text of document 62D/697/FDIS, future edition 1 of IEC 80601-2-59, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, and SC 3, Lung
ventilators and related equipment, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted
to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 80601-2-59 on 2009-11-17.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2010-09-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2012-12-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
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.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS 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 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.

- 3 - EN 80601-2-59:2009
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 80601-2-59:2008 + corrigendum April 2009 was approved by
CENELEC as a European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
ISO/IEC 17025 NOTE  Harmonized as EN ISO/IEC 17025:2005 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Addition:
1)
ISO/TR 13154 - Medical electrical equipment - - -
Deployment, implementation and operational
guidelines for indentifying febrile humans
using a screening thermograph
ASTM E1213-97 2002 Standard Test Method for Minimum - -
Resolvable Temperature Difference for
Thermal Imaging Systems
1)
Undated reference.
- 5 - EN 80601-2-59:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC with the exception of
Essential Requirements 3 and 10.1.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
__________
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 2-8318-1004-5

– 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
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
...