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)

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 (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)

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: Not Published
• Public Enquiry End Date: 31-Oct-2023
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Mar-2025
• Due Date: 10-May-2025
• Ref Project: 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

Relations

• Revises: SIST 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 (IEC 80601-2-71:2015)
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-71:2023
01-oktober-2023
Medicinska električna oprema - 2-71. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti funkcionalne opreme spektrometra v bližnjem infrardečem
spektru
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and
essential performance of functional near-infrared spectroscopy (NIRS) equipment
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
Ta slovenski standard je istoveten z: prEN IEC 80601-2-71:2023
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
oSIST prEN IEC 80601-2-71:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN IEC 80601-2-71:2023

oSIST prEN IEC 80601-2-71:2023

62D/2062/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-71 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-09-01 2023-11-24
SUPERSEDES DOCUMENTS:
62D/1924/CD, 62D/1950A/CC
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
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
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
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.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In So me Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

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

PROPOSED STABILITY DATE: 2029
NOTE FROM TC/SC OFFICERS:
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.

oSIST prEN IEC 80601-2-71:2023
62D/2026/CDV – 2 – IEC 80601-2-71:2023 © IEC 2023

ISO 80601-2-71:2023(E) (Ed 2)
62D/2062/CDV
ISO/TC 121/SC 3/ N2998
Secretariat: ANSI
2023-06-15
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 d'imagerie spectroscopique proche
infrarouge (NIRS)
Draft CDV stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject
to change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent
rights of which they are aware and to provide supporting documentation.

oSIST prEN IEC 80601-2-71:2023
IEC 80601-2-71:2023 © IEC 2023 – 3 – 62D/2062/CDV
2 CONTENTS
4 FOREWORD . 5
5 INTRODUCTION . 7
6 201.1 Scope, object and related standards . 8
7 201.2 Normative references . 10
8 201.4 General requirements . 13
9 201.5 General requirements for testing ME EQUIPMENT . 14
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
11 201.7 ME EQUIPMENT identification, MARKING and documents . 14
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENt and ME SYSTEMS . 15
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 15
15 201.11 Protection against excessive temperatures and other HAZARDS . 16
16 201.12 Accuracy of controls and instruments and protection against hazardous
17 outputs . 17
18 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 28
19 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
20 201.15 Construction of ME EQUIPMENT . 28
21 201.16 ME SYSTEMS . 28
22 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 29
23 201.101 Requirements for the FUNCTIONAL NIRS EQUIPMENT ACCESSORIES . 29
24 202 Electromagnetic disturbances — Requirements and tests . 29
25 206 Useability . 30
26 206.101 PRIMARY OPERATING FUNCTIONS . 30
27 Annexes . 31
28 Annex C (informative) Guide to MARKING and labelling requirements for ME EQUIPMENT
29 and ME SYSTEMS . 31
30 Annex AA (informative) Particular guidance and rationale . 33
31 Annex BB (normative) Evaluating ME EQUIPMENT performance using the FUNCTIONAL
32 NIRS PHANTOM . 37
33 Annex CC (informative) Skin temperature at the FUNCTIONAL NIRS PROBE . 46
34 Annex DD (informative) Reference to the IMDRF ESSENTIAL PRINCIPLES and labelling
35 guidances . 47
36 Bibliography . 49
37 Index of defined terms . 53
39 Figure 201.101 –FULL WIDTH AT HALF MAXIMUM of spectral power distribution . 11
40 Figure 201.102 – Measurement of AVERAGE OPTICAL POWER . 18
41 Figure 201.103 – Measurement of PEAK WAVELENGTH and FWHM . 19
42 Figure 201.104 – Measurement of signal stability . 21
43 Figure 201.105 – Measurement of RESPONSE TIME . 22

oSIST prEN IEC 80601-2-71:2023
62D/2062/CDV – 4 – IEC 80601-2-71 © IEC 2023
44 Figure 201.106 – Rise time and fall time in RESPONSE TIME . 23
45 Figure 201.107 – Measurement of the signal-to-noise ratio of the detected light
46 intensity . 24
47 Figure 201.108 – Measurement of signal-to-noise ratio of the PATHLENGTH-DEPENDENT
48 HAEMOGLOBIN CHANGE . 26
49 Figure 201.109 – Measurement of SIGNAL CROSS-TALK . 27
50 Figure BB.1 – The FUNCTIONAL NIRS PHANTOM in two states with different detected light
51 intensities . 40
52 Figure BB.2 – FUNCTIONAL NIRS PHANTOM measurement using the reference system . 41
53 Figure BB.3 – FUNCTIONAL NIRS PHANTOM measurement using the ME EQUIPMENT to be
54 evaluated . 41
55 Figure BB.4 – Schematic for measurement of OPTICAL LOSS . 45
57 Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements . 14
58 Table 201.102 – Performance tests employing the FUNCTIONAL NIRS EQUIPMENT or
59 attenuator and the required OPTICAL LOSS . 18
60 Table 201.C.101 – MARKING on the outside of FUNCTIONAL NIRS EQUIPMENT or their parts . 31
61 Table 201.C.102 – ACCOMPANYING DOCUMENTS general . 31
62 Table 201.C.103 – INSTRUCTIONS FOR USE . 32
63 Table 201.C.104 — TECHNICAL DESCRIPTION . 32
64 Table DD.1 — Correspondence between this document and the IMDRF ESSENTIAL
65 PRINCIPLES . 47
66 Table DD.2 — Correspondence between this document and the IMDRF labelling
67 principles . 48
oSIST prEN IEC 80601-2-71:2023
IEC 80601-2-71:2023 © IEC 2023 – 5 – 62D/2062/CDV
70 INTERNATIONAL ELECTROTECHNICAL COMMISSION
71 ____________
73 MEDICAL ELECTRICAL EQUIPMENT –
75 Part 2-71: Particular requirements for the basic safety and essential
76 performance of functional near-infrared spectroscopy (NIRS) equipment
78 FOREWORD
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