SIST EN IEC 80601-2-59:2019/A1:2023

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/AMD1:2023)

20211012-JO-Link to 93/42/EEC and M/295 removed

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/AMD1:2023)

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/AMD1:2023)

Medicinska električna oprema - 2-59. del: Posebne zahteve za osnovno varnost in bistvene lastnosti presejalnih termografov za spremljanje človekove temperature pri mrzlici - Dopolnilo A1 (IEC 80601-2-59:2017/AMD1:2023)

General Information

• Status: Published
• Public Enquiry End Date: 30-Nov-2021
• Publication Date: 12-Mar-2023
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 02-Mar-2023
• Due Date: 07-May-2023
• Completion Date: 13-Mar-2023
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN IEC 80601-2-59:2019/A1:2023 - Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

Relations

• Amends: SIST EN IEC 80601-2-59:2019 - 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)
• Effective Date: 03-Aug-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 80601-2-59:2019/A1:2023
01-april-2023
Medicinska električna oprema - 2-59. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti presejalnih termografov za spremljanje človekove temperature
pri mrzlici - Dopolnilo A1 (IEC 80601-2-59:2017/AMD1:2023)
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/AMD1:2023)
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/AMD1:2023)
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/AMD1:2023)
Ta slovenski standard je istoveten z: EN IEC 80601-2-59:2019/A1:2023
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 80601-2-59:2019/A1:2023 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/A1:2023

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SIST EN IEC 80601-2-59:2019/A1:2023


EUROPEAN STANDARD EN IEC 80601-2-59:2019/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM February 2023
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 80601-2-59:2017/AMD1:2023)
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/AMD1:2023) (IEC 80601-2-59:2017/AMD1:2023)
This amendment A1 modifies the European Standard EN IEC 80601-2-59:2019; it was approved by CENELEC on 2023-02-22. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye 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
© 2023 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/A1:2023 E

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SIST EN IEC 80601-2-59:2019/A1:2023
EN IEC 80601-2-59:2019/A1:2023 (E)
European foreword
The text of document 62D/1892/CDV, future IEC 80601-2-59/AMD1, 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/A1:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2023-08-22
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-02-22
document have to be withdrawn

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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 80601-2-59:2017/AMD1:2023 was approved by CENELEC
as a European Standard without any modification.
2

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SIST EN IEC 80601-2-59:2019/A1:2023
EN IEC 80601-2-59:2019/A1:2023 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
The Annex ZA of EN IEC 80601-2-59:2019 applies with the following changes:
Publication Year Title EN/HD Year

Replace the first four entries with the following:

IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
+ A2 2020  + A2 2021
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020  + A1 2021
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013  + A1 2015
+ A2 2020  + A2 2021
3

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SIST EN IEC 80601-2-59:2019/A1:2023
EN IEC 80601-2-59:2019/A1:2023 (E)
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
General requirements for basic safety and
essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
+ A1 2012  + A1 2013
- -  + AC 2014
+ A2 2020  + A2 2021

4

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SIST EN IEC 80601-2-59:2019/A1:2023



IEC 80601-2-59


Edition 2.0 2023-01




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




A MENDMENT 1

AM ENDEMENT 1





Medical electrical equipment –

Part 2-59: Particular requirements for the basic safety and essential performance

of screening thermographs for human febrile temperature screening



Appareils electromedicaux –

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 978-2-8322-6357-0




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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SIST EN IEC 80601-2-59:2019/A1:2023
– 2 – IEC 80601-2-59:2017/AMD1:2023
 © IEC 2023
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

AMENDMENT 1

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
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. Interna
...

SLOVENSKI STANDARD
SIST EN IEC 80601-2-59:2019/oprA1:2021
01-november-2021
Dopolnilo A1 - Medicinska električna oprema - 2-59. del: Posebne zahteve za
osnovno varnost in bistvene lastnosti presejalnih termografov za spremljanje
človekove temperature pri mrzlici
Amendment 1 - Medical electrical equipment - Part 2-59: Particular requirements for the
basic safety and essential performance of screening thermographs for human febrile
temperature screening
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
Ta slovenski standard je istoveten z: EN IEC 80601-2-59:2019/prA1:2021
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 80601-2- en
59:2019/oprA1:2021
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/oprA1:2021

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SIST EN IEC 80601-2-59:2019/oprA1:2021
62D/1892/CDV
COMMITTEE DRAFT FOR VOTE (CDV)

PROJECT NUMBER:
IEC 80601-2-59/AMD1 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-09-10 2021-12-03
SUPERSEDES DOCUMENTS:
62D/1888/RR

IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:


Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING


This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.

TITLE:
Amendment 1 - Medical electrical equipment - Part 2-59: Particular requirements for the basic
safety and essential performance of screening thermographs for human febrile temperature
screening

PROPOSED STABILITY DATE: 2027

NOTE FROM TC/SC OFFICERS:
IEC 80601-2-59:2017 ED2 is being amended to align to the Amendment projects of the IEC 60601 -1
series. Refer to IEC 62D/1808/INF and 62D/1828/AC for more information.
Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it,
for any other purpose without permission in writing from IEC.

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SIST EN IEC 80601-2-59:2019/oprA1:2021
IEC CDV 80601-2-59:2017 AMD1:2021
© IEC:2021
– 2 –

FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
Draft Report on voting
62D/XXXX/FDIS 62D/XXXX/RVD

Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer
...