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 applies to the basic safety and essential performance of functional NIRS equipment intended to be used by themselves, or as a part of an ME system, for the production of functional NIRS equipment output for adjunctive diagnostic purposes, hereinafter referred to as ME 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)

IEC 80601-2-71:2015 s'applique à la sécurité de base et aux performances essentielles des appareils NIRS fonctionnelle destinés à être utilisés seuls, ou en tant que partie d'un système EM, pour produire des caractéristiques de sortie d'appareils NIRS fonctionnelle, à des fins de diagnostic d'appoint. Ces appareils sont désignés ci-après appareils EM.

General Information

Status
Published
Publication Date
09-Jun-2015
Current Stage
9599 - Withdrawal of International Standard
Start Date
29-Jul-2025
Completion Date
02-Aug-2025
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IEC 80601-2-71
Edition 1.0 2015-06
INTERNATIONAL
STANDARD
Medical electrical equipment –
Part 2-71: Particular requirements for the basic safety and essential performance
of functional near-infrared spectroscopy (NIRS) equipment
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IEC 80601-2-71
Edition 1.0 2015-06
INTERNATIONAL
STANDARD
Medical electrical equipment –

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

of functional near-infrared spectroscopy (NIRS) equipment

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.55 ISBN 978-2-8322-2717-6

– 2 – IEC 80601-2-71:2015 © IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 13
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other hazards . 13
201.12 ACCURACY of controls and instruments and protection against hazardous
outputs . 13
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 ME SYSTEMS . 21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
Annexes . 22
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 22
Annex AA (informative) Particular guidance and rationale . 23
Annex BB (normative) Evaluating ME EQUIPMENT performance using the FUNCTIONAL
NIRS PHANTOM . 25
Annex CC (informative) Reference to the essential principles . 34
Bibliography . 36
Index of defined terms . 37

Figure 201.101 – FULL WIDTH AT HALF MAXIMUM of spectral power distribution . 10
Figure 201.102 – Measurement of AVERAGE OPTICAL POWER . 14
Figure 201.103 – Measurement of PEAK WAVELENGTH and FWHM . 15
Figure 201.104 – Measurement of signal stability . 16
Figure 201.105 – Measurement of RESPONSE TIME . 17
Figure 201.106 – Rise time and fall time in RESPONSE TIME . 18
Figure 201.107 – Measurement of signal-to-noise ratio . 19
Figure 201.108 – Measurement of SIGNAL CROSS-TALK . 21
Figure 201.BB.1 – The FUNCTIONAL NIRS PHANTOM in two states with different detected
light intensities . 28
Figure BB.2 – FUNCTIONAL NIRS PHANTOM measurement using the reference system . 29

Figure BB.3 – FUNCTIONAL NIRS PHANTOM measurement using the ME EQUIPMENT to be
evaluated . 29
Figure BB.4 – Schematic for measurement of OPTICAL LOSS . 32

Table 201.101 – Performance tests employing the FUNCTIONAL NIRS PHANTOM or
attenuator and the required OPTICAL LOSS . 13
Table 201.C.101 – Marking on the outside of FUNCTIONAL NIRS EQUIPMENT or their parts . 22
Table 201.C.102 – ACCOMPANYING DOCUMENTS, instructions for use of FUNCTIONAL NIRS
EQUIPMENT . 22
Table CC.1 – Correspondence between this particular standard and the essential
principles . 34

– 4 – IEC 80601-2-71:2015 © IEC 2015
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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International standard IEC 80601-2-71 has been prepared by a Joint Working Group of IEC
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice and ISO subcommittee SC3: Lung ventilators and related
equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
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