IEC 80601-2-59:2017/AMD1:2023

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

Amendement 1 - 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

General Information

• Status: Published
• Publication Date: 17-Jan-2023
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 8 - TC 62/SC 62D/JWG 8
• Current Stage: PPUB - Publication issued
• Start Date: 15-Feb-2023
• Completion Date: 18-Jan-2023

Relations

• Amends: 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 2.0 2023-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 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

IEC 80601-2-59:2017-09/AMD1:2023-01(en-fr)

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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

– 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. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 80601-2-59:2017 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems, in co-operation with ISO subcommittee SC 3: Respiratory devices and
related equipment used for patient care, of ISO technical committee 121: Anaesthetic and
respiratory equipment.
It is published as a double logo standard.

© IEC 2023
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/1892/CDV 62D/1938A/RVC
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under 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.
__________
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and the
amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised can be found within the
IEC document 62D/1792/DC. The results and comments on the DC can be found within
62D/1808/INF. The review report for this amendment is 62D/1888/RR.

– 4 – IEC 80601-2-59:2017/AMD1:2023
© IEC 2023
201.1 Scope, object and related standards
Replace the existing text in footnote 2 with the following:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance.

201.1.3 Collateral standards
Replace, in the existing second paragraph, the first sentence with the following:
IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 apply as modified in
Clauses 202 and 206 respectively.

201.1.4 Particular standards
Replace, in the third paragraph, the first sentence with the following:
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are referred to in this particular document as the general
standard. Collateral standards are referred to by their document number.
Replace, in the eighth paragraph, "3.147" with "3.154".

201.2 Normative references
Replace the first four entries with the following:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: 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
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
© IEC 2023
201.3 Terms and definitions
Replace the existing first sentence with the following:
For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005
...