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 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
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
• Drafting Committee: ISO/TC 121/SC 3/JWG 10 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Oximeters
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 14-Jan-2021

Relations

• Consolidated By: ISO 18750:2018 - Intelligent transport systems — Co-operative ITS — Local dynamic map
• Effective Date: 06-Jun-2022

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
IEC 80601-2-71:2015-06(en)

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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



  Warning! Make sure that you obtained this publication from an authorized distributor.

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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

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IEC 80601-2-71:2015 © IEC 2015 – 3 –
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

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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
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
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.

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IEC 80601-2-71:2015 © IEC 2015 – 5 –
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 is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in 0.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.
NOTE The attention of National Committees and Member Bodies is drawn to the fact that equipment
manufacturers and testing organizations may need a transitional period following publication of a new, amended or
revised IEC or ISO publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committees that the content of this
publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

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INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of FUNCTIONAL NIRS EQUIPMENT.
The requirements are followed by specifications for the relevant tests.
A "Particular guidance and rationale" text giving some explanatory notes, where appropriate,
about the more important requirements is included in Annex AA. It is considered that
knowledge of the reasons for these requirements will not only facilitate the proper application
of the standard but will, in due course, expedite any revision necessitated by changes in
clinical practice or as a result of developments in technology. However, this annex does not
form part of the requirements of this standard.

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IEC 80601-2-71:2015 © IEC 2015 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

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



201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International standard 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.
Not included within the scope of this particular standard are:
a) the part of ME EQUIPMENT, if provided, that measures oxygen saturation of the haemoglobin
in the micro vessels (capillaries, arterioles and venules);
b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for
obtaining FUNCTIONAL NIRS EQUIPMENT output;
c) pulse oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT
output. The requirements for pulse oximeter equipment are found in ISO 80601-2-61.
d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy,
which may require different test procedures than defined herein.
e) FUNCTIONAL NEAR-INFRARED SPECTROSCOPY EQUIPMENT which measure changes in the
concentration of chromophores other than oxy- and deoxy-haemoglobin, which may
require different test procedures than defined herein.
201.1.2 OBJECT
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for FUNCTIONAL NIRS EQUIPMENT as defined in 201.3.205.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
—————————
1
 The general standard is IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.

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2
IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard or collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012 is referred to in this particular
standard as the general standard. Collateral standards are referred to by their document
number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 6 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
—————————
2
IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers.

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IEC 80601-2-71:2015 © IEC 2015 – 9 –
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety
and essential performance – Collateral standard: Usability
IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and
requirements
Addition:
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
ISO 80601-2-61, Medical electrical equipment – Part 2-61: Particular requirements for the
basic safety and essential performance of pulse oximeter equipment
ISO/TR 16142:2006, Medical devices – Guidance on the selection of standards in support of
recognized essential principles of safety and performance of medical devices
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1,
IEC 60601-1-6, ISO/TR 16142:2006 and IEC 60825-1:2014 and the following apply.
Addition:
201.3.201
AVERAGE OPTICAL POWER
temporal average power of continuous light or repeated light pulses from each discrete
wavelength, from the EMITTER PROBE connected to the FUNCTIONAL NIRS MONITOR
201.3.202
DETECTOR PROBE
part of the FUNCTIONAL NIRS EQUIPMENT which detects light from the living tissue that forms
part of the APPLIED PART
201.3.203
EMITTER PROBE
part of the FUNCTIONAL NIRS EQUIPMENT which emits light to the living tissue that forms part of
the APPLIED PART
201.3.204
FWHM
FULL WIDTH AT HALF MAXIMUM OF SPECTRAL POWER DISTRIBUTION
difference of the wavelength between the two points whose corresponding power values are
equal and 3 dB lower than the values at each PEAK WAVELENGTH
Note 1 to entry: FWHM is the measurement of spectral power distribution illuminated from the EMITTER PROBE
connected to the FUNCTIONAL NIRS MONITOR. Figure 201.101 provides a visual representation. If there are more than
two wavelengths where power value is 3 dB lower than the values at each PEAK WAVELENGTH, FWHM shall be
calculated from the difference between minimum and maximum wavelengths.

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FWHM
Wavelength

IEC
Figure 201.101 – FULL WIDTH AT HALF MAXIMUM of spectral power distribution
201.3.205
FUNCTIONAL NIRS EQUIPMENT
FUNCTIONAL NEAR-INFRARED SPECTROSCOPY EQUIPMENT
ME EQUIPMENT that measures PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE in living tissue by
illuminating tissue and detecting changes in the infrared and visible light intensity diffusively
reflected from the tissue
201.3.206
FUNCTIONAL NIRS MONITOR
FUNCTIONAL NEAR-INFRARED SPECTROSCOPY MONITOR
part of the FUNCTIONAL NIRS EQUIPMENT that encompasses the electronics, display and
operator-equipment interface excluding the EMITTER PROBE and DETECTOR PROBE
201.3.207
FUNCTIONAL NIRS PHANTOM
apparatus that simulates a PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE by giving the
ME EQUIPMENT a specified known change in OPTICAL LOSS to evaluate the difference between
the measured value of the pseudo PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE and the
reference value calculated from the attenuation change
Note 1 to entry: The FUNCTIONAL NIRS PHANTOM plays a role in determining the performance of FUNCTIONAL NIRS
EQUIPMENT, especially PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE measurement. A description of the function
and specifications regarding the manufacturing of the FUNCTIONAL NIRS PHANTOM is found in Annex BB.
Note 2 to entry: A FUNCTIONAL NIRS PHANTOM is developed during design and is used at the time of inspection in
manufacturing or after being placed into service.
201.3.208
MEASUREMENT CHANNEL
combination of an EMITTER PROBE and a DETECTOR PROBE that provide an output
201.3.209
OPTICAL LOSS
ratio of the total optical power exiting the FUNCTIONAL NIRS PHANTOM or attenuator through a
specified aperture, to the optical power emitted by the EMITTER PROBE connected to the
FUNCTIONAL NIRS MONITOR
Power
3 dB

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IEC 80601-2-71:2015 © IEC 2015 – 11 –
–X/10
Note 1 to entry: The OPTICAL LOSS is denoted in dB. X dB OPTICAL LOSS is equivalent to 10 .
Note 2 to entry: The optical power exiting the EMITTER PROBE and the FUNCTIONAL NIRS PHANTOM can be measured
with an optical power meter.
Note 3 to entry: For details of the measurement of the OPTICAL LOSS refer to Annex BB.3.2
201.3.210
PATHLENGTH-DEPENDENT DEOXYHAEMOGLOBIN CHANGE
value calculated from the received signals of the ME EQUIPMENT given by the multivariate
modified Beer-Lambert law whose equation is shown in Annex BB.2 and which is equal to the
product of the change in the concentration of deoxyhaemoglobin and the mean optical
pathlength
201.3.211
PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE
∆c∙L
collective term which signifies the product of apparent haemoglobin concentration change and
the mean optical pathlength inclusive of two chromophores (oxyhaemoglobin and
deoxyhaemoglobin), as well as total haemoglobin change
Note 1 to entry: The calculation of the PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE from measured changes in
attenuation is described in Annex BB.2.
201.3.212
PATHLENGTH-DEPENDENT OXYHAEMOGLOBIN CHANGE
value calculated from the received signal of the ME EQUIPMENT given by the multivariate
modified Beer-Lambert law, equal to the apparent value of the product of the change in
concentration of oxyhaemoglobin and the mean optical pathlength
Note 1 to entry: Oxyhaemoglobin is the haemoglobin bonded with oxygen molecules.
201.3.213
PATHLENGTH-DEPENDENT TOTAL HAEMOGLOBIN CHANGE
value calculated as a sum of PATHLENGTH-DEPENDENT OXYHAEMOGLOBIN CHANGE and
PATHLENGTH-DEPENDENT DEOXYHAEMOGLOBIN CHANGE
201.3.214
PEAK WAVELENGTH
wavelength where the power is the largest in the spectral power distribution for each of the
distinct NOMINAL wavelengths in the light radiated from the EMITTER PROBE
201.3.215
RESPONSE TIME
time required for the step response of the ME EQUIPMENT to move from its specified
percentage of the final steady-state value to the other specified percentage
Note 1 to entry: RESPONSE TIME is conventionally denoted by the rise time or fall time that represents the interval
between the times corresponding to 10 % and 90 % of the step response amplitude during the transition. See also
201.12.1.101.7 and Figure 201.106.
201.3.216
SIGNAL CROSS-TALK
signal cont
...