IEC 80601-2-71:2015

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 de spectroscopie dans le proche infrarouge (NIRS) fonctionnelle

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: 08-Jun-2015
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 5 - TC 62/SC 62D/JWG 5
• Current Stage: PPUB - Publication issued
• Start Date: 15-Jul-2015
• Completion Date: 09-Jun-2015

Standards Content (Sample)

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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

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and withdrawn publications. have been collected from earlier publications of IEC TC 37,

77, 86 and CISPR.
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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
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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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.
This publication is published as a double logo standard.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1238/FDIS 62D/1261/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by 14 P-members
out of 14 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions
...

IEC 80601-2-71
Edition 1.0 2015-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

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The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and
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IEC 80601-2-71
Edition 1.0 2015-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-6318-1

– 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
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and t
...