EN IEC 80601-2-71:2025

Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

IEC 80601-2-71:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT, as defined in 201.3.205, intended to be used by itself, or as a part of an ME SYSTEM hereinafter referred to as ME EQUIPMENT. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1. This document is not applicable to – equipment for the measurement of oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules), i.e. tissue oximeters; – frequency-domain and time-domain equipment for functional near-infrared spectroscopy; – equipment for the measurement of changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin; – equipment for the measurement of changes in the concentration of oxy- and deoxy-haemoglobin in tissues other than the brain. This document does not specify the requirements for: – cerebral tissue oximeter equipment, which are given in ISO 80601-2-85; and – pulse oximeter equipment, which are given in ISO 80601-2-61. IEC 80601-2-71:2025 cancels and replaces the first edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-8:2006/AMD2:2020, 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; b) added requirements for ESSENTIAL PERFORMANCE; c) added requirements for PRIMARY OPERATING FUNCTIONS; d) added requirements for protection against excessive temperatures; e) added requirements for the display legibility for OPERATORS wearing personal protective equipment; f) harmonization with ISO 20417, where appropriate.

Medizinische elektrische Geräte - Teil 2-71: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von funktionalen Oximetriegeräten

Appareils électromédicaux - Partie 2-71: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de spectroscopie dans le proche infrarouge (NIRS) fonctionnelle

L'IEC 60601-2-71:2025 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE, désignés ci-après sous le terme APPAREILS EM. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM, ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les APPAREILS EM suivants sont exclus de la liste: • APPAREILS EM destinés à une application thérapeutique; • APPAREILS EM destinés à être utilisés avec les neurostimulateurs électriques transcutanés et les stimulateurs musculaires électriques (APPAREILS EM couverts par l'IEC 60601-2-10). L'IEC 60601-2-71:2025 annule et remplace la deuxième édition parue en 2016. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) des exigences relatives aux stimulateurs à tension constante ont été ajoutées; b) des exigences relatives aux STIMULATEURS VISUELS ont été clarifiées. L'IEC 80601-2-71:2025 concerne la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS NIRS FONCTIONNELLE, définis au 201.3.205, destinés à être utilisés seuls ou en tant que partie d'un SYSTEME EM, ci-après appelés APPAREILS EM. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM compris dans le domaine d'application du présent document ne sont pas couverts par des exigences spécifiques dans le présent document, en dehors de l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020, 7.2.13 et 8.4.1. Le présent document ne s'applique pas – Aux appareils qui mesurent la saturation en oxygène de l'hémoglobine dans les vaisseaux sanguins de très petite taille (capillaires, artérioles et veinules), c'est-à-dire aux oxymètres pour tissu. – Aux appareils dans le domaine temporel et de la fréquence pour la spectroscopie dans le proche infrarouge fonctionnelle. – Aux appareils qui mesurent les modifications de concentration en chromophores autres que l'oxyhémoglobine et la désoxyhémoglobine. – Aux appareils qui mesurent les modifications de concentration en oxyhémoglobine et en désoxyhémoglobine dans les tissus autres que le cerveau. Le présent document ne spécifie pas les exigences concernant: – les oxymètres pour tissu cérébral, qui sont données dans l'ISO 80601-2-85; et – les oxymètres de pouls, qui sont données dans l'ISO 80601-2-61. L'IEC 80601-2-71:2025 annule et remplace la première édition parue en 2015. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) alignement sur l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012, l'IEC 60601-1:2005/AMD2:2020, l'IEC 60601-1-8:2006, l'IEC 60601-1-8:2006/AMD1:2012, l'IEC 60601-1-8:2006/AMD2:2020, l'IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, l'IEC 60601-1-6:2010/AMD1:2013 et l'IEC 60601-1-6:2010/AMD2:2020; b) ajout d'exigences concernant les PERFORMANCES ESSENTIELLES; c) ajout d'exigences concernant les FONCTIONS PRINCIPALES DE SERVICE; d) ajout d'ex

Medicinska električna oprema - 2-71. del: Posebne zahteve za osnovno varnost in bistvene lastnosti funkcionalne opreme spektrometra v bližnjem infrardečem spektru (IEC 80601-2-71:2025)

General Information

• Status: Published
• Publication Date: 27-Feb-2025
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 28-Feb-2025
• Due Date: 29-Dec-2023
• Completion Date: 28-Feb-2025
• Ref Project: SIST EN IEC 80601-2-71:2025 - Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (IEC 80601-2-71:2025)

Relations

• Replaces: EN IEC 80601-2-71:2018 - Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
• Effective Date: 09-Dec-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2025
Medicinska električna oprema - 2-71. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti funkcionalne opreme spektrometra v bližnjem infrardečem
spektru (IEC 80601-2-71:2025)
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and
essential performance of functional near-infrared spectroscopy (NIRS) equipment (IEC
80601-2-71:2025)
Medizinische elektrische Geräte - Teil 2-71: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von funktionalen Oximetriegeräten
(IEC 80601-2-71:2025)
Appareils électromédicaux - Partie 2-71: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de spectroscopie dans le proche
infrarouge (NIRS) fonctionnelle (IEC 80601-2-71:2025)
Ta slovenski standard je istoveten z: EN IEC 80601-2-71:2025
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 80601-2-71

NORME EUROPÉENNE
EUROPÄISCHE NORM February 2025
ICS 11.040.55 Supersedes EN IEC 80601-2-71:2018
English Version
Medical electrical equipment - Part 2-71: Particular requirements
for the basic safety and essential performance of functional near-
infrared spectroscopy (NIRS) equipment
(IEC 80601-2-71:2025)
Appareils électromédicaux - Partie 2-71: Exigences Medizinische elektrische Geräte - Teil 2-71: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de spectroscopie dans le proche wesentlichen Leistungsmerkmale von funktionalen
infrarouge (NIRS) fonctionnelle Oximetriegeräten
(IEC 80601-2-71:2025) (IEC 80601-2-71:2025)
This European Standard was approved by CENELEC on 2025-02-18. 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
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
© 20252025 All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
CENELEC
Ref. No. EN IEC 80601-2-71:2025 E

European foreword
The text of document 62D/2169/FDIS, future edition 2 of IEC 80601-2-71, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-02-28
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-02-29
document have to be withdrawn
This document supersedes EN IEC 80601-2-71:2018 and all of its amendments and corrigenda (if
any).
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 80601-2-71:2025 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
ISO 80601-2-85:2021 NOTE Approved as EN ISO 80601-2-85:2021 (not modified)
ISO 80601-2-61:2017 NOTE Approved as EN ISO 80601-2-61:2019 (not modified)
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
IEC 60601-2-57:2023 NOTE Approved as EN IEC 60601-2-57:— (not modified)
ISO 14159:2002 NOTE Approved as EN ISO 14159:2008 (not modified)

Under preparation. Stage at the time of publication: FprEN IEC 60601-2-57:2023.
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.cencenelec.eu.
Annex ZA of EN 60601-1:2006 , applies, except as follows:
Add:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 60825-1 2014 Safety of laser products - Part 1: EN 60825-1 2014
Equipment classification and requirements
- - + A11 2021
- - + AC 2017-06
IEC 62471 (mod) 2006 Photobiological safety of lamps and lamp EN 62471 2008
systems
IEC 62570 2014 Standard practice for marking medical EN 62570 2015
devices and other items for safety in the
magnetic resonance environment

As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
Publication Year Title EN/HD Year
ISO 17664-1 2021 Processing of health care products - EN ISO 17664-1 2021
Information to be provided by the medical
device manufacturer for the processing of
medical devices - Part 1: Critical and semi-
critical medical devices
ISO 17664-2 2021 Processing of health care products - EN ISO 17664-2 2023
Information to be provided by the medical
device manufacturer for the processing of
medical devices - Part 2: Non-critical
medical devices
ISO 20417 2021 Medical devices - Information to be EN ISO 20417 2021
supplied by the manufacturer
IEC 80601-2-71
Edition 2.0 2025-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-71: Particular requirements for the basic safety and essential performance

of functional near-infrared spectroscopy (NIRS) equipment

Appareils électromédicaux –
Partie 2-71: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils de spectroscopie dans le proche infrarouge (NIRS)

fonctionnelle
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8327-0096-9

– 2 – IEC 80601-2-71:2025 © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, MARKING and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS. 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT. 29
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 29
201.15 Construction of ME EQUIPMENT . 29
201.16 ME SYSTEMS . 30
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30
201.101 Requirements for the FUNCTIONAL NIRS EQUIPMENT ACCESSORIES . 30
202 Electromagnetic disturbances – Requirements and tests . 30
206 Usability . 31
Annexes . 32
Annex C (informative) Guide to MARKING and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 33
Annex AA (informative) Particular guidance and rationale . 35
ANNEX BB (normative) Evaluating ME EQUIPMENT performance using the FUNCTIONAL
NIRS PHANTOM . 39
ANNEX CC (informative) Skin temperature at the FUNCTIONAL NIRS PROBE . 48
Annex DD (informative) Reference to the IMDRF essential principles and labelling
guidance . 49
Bibliography . 51
Index of defined terms . 55

Figure 201.101 – FULL WIDTH AT HALF MAXIMUM OF SPECTRAL POWER DISTRIBUTION . 11
Figure 201.102 – Measurement of the AVERAGE OPTICAL POWER. 19
Figure 201.103 – Measurement of PEAK WAVELENGTH and FWHM . 20
Figure 201.104 – Measurement of the signal stability . 22
Figure 201.105 – Measurement of the RESPONSE TIME . 23
Figure 201.106 – Rise time and fall time in the RESPONSE TIME . 24
Figure 201.107 – Measurement of the signal-to-noise ratio of the detected light
intensity . 25

IEC 80601-2-71:2025 © IEC 2025 – 3 –
Figure 201.108 – Measurement of signal-to-noise ratio of the PATHLENGTH-DEPENDENT
HAEMOGLOBIN CHANGE . 27
Figure 201.109 – Measurement of SIGNAL CROSS-TALK . 28
Figure BB.1 – The FUNCTIONAL NIRS PHANTOM in two states with different detected light
intensities . 42
Figure BB.2 – FUNCTIONAL NIRS PHANTOM measurement using the reference system . 43
Figure BB.3 – FUNCTIONAL NIRS PHANTOM measurement using the ME EQUIPMENT to be
evaluated .
...