FprEN IEC 80601-2-71:2024

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
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CENELEC, is drawn to the fact that this Committee Draft
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Recipients of this document are invited to submit, with their comments, notification of any relevant “In So me Countries”
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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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