IEC 80601-2-71:2025
(Main)Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (functional NIRS) equipment
Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (functional NIRS) equipment
This document 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.
Appareils électromédicaux — Partie 2-71: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'imagerie spectroscopique proche infrarouge (NIRS)
Le présent document 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 [1]1; et les oxymètres de pouls, qui sont données dans l'ISO 80601-2-61 [2].
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International
Standard
IEC/FDIS
80601-2-71
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-71:
Voting begins on:
2024-09-20
Particular requirements for
the basic safety and essential
Voting terminates on:
2024-11-15
performance of functional near-
infrared spectroscopy (functional
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)
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
IEC/FDIS 80601-2-71:2024(en) © IEC 2024
FINAL DRAFT
IEC/FDIS 80601-2-71:2024(en)
International
Standard
IEC/FDIS
80601-2-71
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-71:
Voting begins on:
Particular requirements for
2024-09-20
the basic safety and essential
Voting terminates on:
2024-11-15
performance of functional near-
infrared spectroscopy (functional
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)
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 SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
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This draft is submitted to a parallel vote in ISO and in IEC.
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
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MADE IN NATIONAL REGULATIONS.
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IEC/FDIS 80601-2-71:2024(en) © IEC 2024
© IEC 2024 – All rights reserved
ii
– 2 – IEC FDIS 80601-2-71 © IEC 2024
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 . 15
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. 28
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 Construction of ME EQUIPMENT . 28
201.16 ME SYSTEMS . 29
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 29
201.101 Requirements for the FUNCTIONAL NIRS EQUIPMENT ACCESSORIES . 29
202 Electromagnetic disturbances – Requirements and tests . 29
206 Useability . 30
Annexes . 31
Annex C (informative) Guide to MARKING and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 32
Annex AA (informative) Particular guidance and rationale . 34
ANNEX BB (normative) Evaluating ME EQUIPMENT performance using the FUNCTIONAL
NIRS PHANTOM . 38
ANNEX CC (informative) Skin temperature at the FUNCTIONAL NIRS PROBE . 47
Annex DD (informative) Reference to the IMDRF essential principles and labelling
guidance . 48
Bibliography . 50
Index of defined terms . 54
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 . 21
Figure 201.105 – Measurement of the RESPONSE TIME . 22
Figure 201.106 – Rise time and fall time in the RESPONSE TIME . 23
IEC FDIS 80601-2-71 © IEC 2024 – 3 –
Figure 201.107 – Measurement of the signal-to-noise ratio of the detected light
intensity . 24
Figure 201.108 – Measurement of signal-to-noise ratio of the PATHLENGTH-DEPENDENT
............................................................................................................ 26
HAEMOGLOBIN CHANGE
Figure 201.109 – Measurement of SIGNAL CROSS-TALK . 27
Figure BB.1 – The FUNCTIONAL NIRS PHANTOM in two states with different detected light
intensities . 41
Figure BB.2 – FUNCTIONAL NIRS PHANTOM measurement using the reference system . 42
Figure BB.3 – FUNCTIONAL NIRS PHANTOM measurement using the ME EQUIPMENT to be
evaluated . 42
Figure BB.4 – Schematic for measurement of OPTICAL LOSS . 46
Table 201.101 ─ Distributed ESSENTIAL PERFORMANCE requirements . 14
Table 201.102 – Performance tests employing the FUNCTIONAL NIRS EQUIPMENT or
attenuator and the required OPTICAL LOSS . 18
Table 201.C.101 – MARKING on the outside of FUNCTIONAL NIRS EQUIPMENT or their parts . 32
Table 201.C.102 – ACCOMPANYING DOCUMENTS general . 32
Table 201.C.103 – INSTRUCTIONS FOR USE . 33
Table 201.C.104 – TECHNICAL DESCRIPTION . 33
Table DD.1 – Correspondence between this document and the IMDRF essential
principles . 48
Table DD.2 – Correspondence between this document and the IMDRF labelling
principles . 49
– 4 – IEC FDIS 80601-2-71 © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-71: Particular requirements for
the basic safety and essential performance of
functional near-infrared spectroscopy (NIRS) equipment
FOREWORD
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IEC 80601-2-71 has been prepared by a Joint Working Group of IEC subcommittee 62D:
Particular medical equipment, software, and systems, of IEC technical committee 62: Medical
equipment, software, and systems, and ISO subcommittee SC3: Respiratory devices and
related equipment used for patient care, of ISO technical committee 121: Anaesthetic and
respiratory equipment. It is an International Standard.
This second edition cancels and replaces the first edition published in 2015. This edition
constitutes a technical revision.
IEC FDIS 80601-2-71 © IEC 2024 – 5 –
This edition includes the following significant technical changes with respect to the previous
edition:
a) alignment with IEC 606
...
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