IEC 80601-2-71:2015
(Main)Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
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
Relations
Overview
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" - defines safety and performance requirements for functional NIRS equipment (often abbreviated as fNIRS). The standard applies to fNIRS devices used alone or as part of a medical electrical (ME) system to produce functional NIRS outputs for adjunctive diagnostic purposes. It sets out test methods, performance verification and essential documentation needed to demonstrate basic safety and essential performance of NIRS medical electrical equipment.
Key Topics and Requirements
- Scope & exclusions: Clarifies what is covered and what is not - for example, it excludes NIRS tissue oximeters not intended for functional output, pulse oximeters (see ISO 80601-2-61), frequency‑domain/time‑domain systems that require different tests, and devices measuring chromophores beyond oxy-/deoxy‑haemoglobin.
- Safety & performance structure: Builds on IEC 60601‑1 general requirements for ME equipment and provides particular requirements specific to functional NIRS devices.
- Electrical and mechanical protection: Requirements for protection against electrical hazards, mechanical hazards, excessive temperatures and unwanted radiation.
- Optical performance and measurements: Defines optical tests and metrics referenced in figures and tables - e.g., spectral power distribution (FWHM), average optical power, peak wavelength, signal stability, response time, rise/fall time, signal‑to‑noise ratio, and signal cross‑talk.
- Performance testing tools: Normative and informative annexes include a FUNCTIONAL NIRS PHANTOM (Annex BB) and guidance for using phantoms/attenuators to evaluate ME equipment performance.
- Identification, marking, documentation: Labelling requirements, instructions for use, and accompanying documents to support safe clinical use.
- Programmable systems & EMC: Requirements for programmable electrical medical systems (PEMS) and electromagnetic compatibility testing for ME equipment and ME systems.
Practical Applications - Who Uses This Standard
- Manufacturers of functional NIRS/fNIRS devices for design, risk management, verification and regulatory submissions.
- Regulatory and compliance teams preparing technical files and conformity assessments for markets that reference IEC standards.
- Test laboratories and certification bodies executing the standard’s test methods (including phantom‑based performance tests).
- Biomedical and clinical engineers, procurement specialists and hospital technology managers specifying safe, compliant fNIRS systems for research and adjunctive diagnostics.
- R&D teams developing new NIRS hardware and systems that must meet IEC 80601‑2‑71 safety and performance expectations.
Related Standards
- IEC 60601‑1 - General requirements for basic safety and essential performance of medical electrical equipment (collateral).
- ISO/IEC references and collateral standards cited in the standard (see Clause 2); ISO 80601‑2‑61 applies to pulse oximeters (not covered here).
This standard is essential for ensuring that functional NIRS equipment meets internationally accepted safety, performance and testing practices for clinical and research environments.
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
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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
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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 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.
– 6 – IEC 80601-2-71:2015 © IEC 2015
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.
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
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.
—————————
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.
– 8 – IEC 80601-2-71:2015 © IEC 2015
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.
—————————
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.
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.
– 10 – IEC 80601-2-71:2015 © IEC 2015
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
–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 contamination or interference from the other MEASUREMENT CHANNEL(s) to the relevant
channel in multiple channel equipment
– 12 – IEC 80601-2-71:2015 © IEC 2015
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
For the purposes of this standard, FUNCTIONAL NIRS EQUIPMENT is considered not to have
ESSENTIAL PERFORMANCE. Notwithstanding this fact, when this standard refers to ESSENTIAL
PERFORMANCE as an acceptance criterion, the AVERAGE OPTICAL POWER shall be evaluated.
AVERAGE OPTICAL POWER as
Subclause 201.12.1.101.2 indicates a method of evaluating
acceptance criterion following specific tests required by this standard.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts
The marking on the ME EQUIPMENT shall be clearly legible and shall include its classification as
specified in Clause 7 of IEC 60825-1:2014.
201.7.9 ACCOMPANYING DOCUMENTS
Additional subclause:
201.7.9.2.101 Additional requirements for instructions for use
The performances specified in 201.12.1.101 shall be disclosed in the instructions for use.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.3 Classification of APPLIED PARTS
Additional subclause:
201.8.3.101 Additional requirements for classification of APPLIED PARTS
APPLIED PARTS of FUNCTIONAL NIRS EQUIPMENT shall be TYPE BF or TYPE CF APPLIED PARTS.
Compliance is checked by inspection.
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME
SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other hazards
Clause 11 of the general standard applies.
201.12 ACCURACY of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Additional subclauses:
201.12.1.101 Performance of FUNCTIONAL NIRS EQUIPMENT
201.12.1.101.1 General
In the following performance test items, if there are multiple EMITTER PROBES and DETECTOR
PROBES, combinations of EMITTER PROBES and DETECTOR PROBES should be selected according
to RISK MANAGEMENT defined by each MANUFACTURER. The selected combinations shall be
recorded.
The FUNCTIONAL NIRS PHANTOM and the attenuator consisting of scattering and absorbing
materials with the required OPTICAL LOSS shall be used for testing the performance of
FUNCTIONAL NIRS EQUIPMENT as shown in Table 201.101.
Table 201.101 – Performance tests employing the FUNCTIONAL
NIRS PHANTOM or attenuator and the required OPTICAL LOSS
FUNCTIONAL
Performance Attenuator OPTICAL LOSS
NIRS PHANTOM
PATHLENGTH-DEPENDENT HAEMOGLOBIN State A: > 40 dB, state B: 3 dB to 4 dB
✔
CHANGE larger than in state A
Signal stability ✔
> 40 dB
State A: > 40 dB, state B: 3 dB to
RESPONSE TIME ✔
4 dB larger than in state A
State A: > 60 dB, state B: 3 dB to
Signal-to-noise ratio ✔
4 dB larger than in state A
– 14 – IEC 80601-2-71:2015 © IEC 2015
FUNCTIONAL
Performance Attenuator OPTICAL LOSS
NIRS PHANTOM
SIGNAL CROSS-TALK ✔ > 40 dB
NOTE 1 The FUNCTIONAL NIRS PHANTOM can also be used as an attenuator with the same OPTICAL LOSS.
NOTE 2 For the measurement of signal-to-noise ratio, the FUNCTIONAL NIRS PHANTOM with > 40 dB can be used,
with an appropriate neutral density filter added.
201.12.1.101.2 AVERAGE OPTICAL POWER
The AVERAGE OPTICAL POWER of the ME EQUIPMENT shall be measured for each EMITTER PROBE
and for each light source and disclosed in the instructions for use.
1 3
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
3 Power Meter
Figure 201.102 – Measurement of AVERAGE OPTICAL POWER
Compliance is checked by inspection of the instructions for use and the following test.
a) Set up the ME EQUIPMENT and power meter and indicators shown in Figure 201.102.
b) Confirm that the size of effective light-receiving area is sufficiently larger than the beam
size on the area. If not, the beam should be made convergent using a suitable adjunct
optical element. A suitable adapter should be used to appropriately fix the EMITTER PROBE.
c) Measure the AVERAGE OPTICAL POWER with the detector of the power meter and verify that
the value is within the limit specified by the maximum permissible exposure (MPE) of skin
(IEC 60825-1:2014).
201.12.1.101.3 PEAK WAVELENGTH
The PEAK WAVELENGTHS of the ME EQUIPMENT shall be measured and disclosed in the
instructions for use.
1 4
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
4 Spectrophotometer or optical spectrum analyzer
Figure 201.103 – Measurement of PEAK WAVELENGTH and FWHM
Compliance is checked by inspection of the instructions for use and the following test.
a) Set up the ME EQUIPMENT, a spectrophotometer or an optical spectrum analyzer and an
indicator as shown in Figure 201.103.
b) Measure the wavelength with the spectrophotometer or an optical spectrum analyzer and
verify that the value is within the specified limit.
c) If the channel of the ME EQUIPMENT has more than one light source, the measurement shall
be performed for each light source.
201.12.1.101.4 FULL WIDTH AT HALF MAXIMUM OF SPECTRAL DISTRIBUTION
The FWHM of the spectral distribution shall be measured and disclosed in the instructions for
use for each light source.
Compliance is checked by inspection of the instructions for use and the following test.
a) Set up the ME EQUIPMENT, a spectrophotometer or an optical spectrum analyzer and an
indicator as shown in Figure 201.103.
b) Measure the spectral distribution of the output of the ME EQUIPMENT with the
spectrophotometer or optical spectrum analyzer.
c) The FWHM is obtained from the spectral distribution according to the definition in
201.3.204.
d) If the channel of the ME EQUIPMENT has more than one light source, the measurement shall
be performed for each light source.
NOTE The spectral power distribution related to each NOMINAL wavelength of the ME EQUIPMENT is considered
separately.
201.12.1.101.5 PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE
The PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE shall be measured and disclosed in the
instructions for use.
Compliance is checked by inspection of the instructions for use and the test described in
Annex BB.
201.12.1.101.6 Signal stability
The signal stability of the ME EQUIPMENT shall be measured and disclosed in the instructions
for use.
Compliance is checked by inspection of the instructions for use and the following test.
– 16 – IEC 80601-2-71:2015 © IEC 2015
a) Set up the ME EQUIPMENT by selecting an EMITTER PROBE, a DETECTOR PROBE, and an
attenuator as shown in Figure 201.104
b) The attenuator is made of optical filter or scattering attenuating material that has more
than 40 dB OPTICAL LOSS for each applicable wavelength. The OPTICAL LOSS is measured in
advance with an optical power meter or, in case of an optical filter, with a
spectrophotometer.
c) Turn on the mains power switches of all the instruments and wait until the instruments
warm up sufficiently if necessary.
d) Set the power of ME EQUIPMENT to the maximum level.
e) Obtain data samples of the PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE as a time series
for more than 15 min and PROCESS with a filter which has a time constant of less than 5 s.
f) Calculate signal stability, S , for oxyhaemoglobin and deoxyhaemoglobin
stab
g) The signal stability, S , is given by the following formula.
stab
k
(∆ c ⋅ L) – ∆ c ⋅ L
∑
j
j =1
S =
stab
k – 1
k
(∆ c ⋅ L)
∑ j
j =1
where ∆ c ⋅ L = and k denotes the number of samples in a time series.
k
NOTE ∆ c ⋅ L is related to the change from the baseline sample, not a change in the attenuation.
The larger value of the S for oxyhaemoglobin and deoxyhaemoglobin is taken as the
stab
signal stability.
2 5
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
5 DETECTOR PROBE
6 Attenuator
NOTE Attenuator OPTICAL LOSS for this test: > 40 dB
Figure 201.104 – Measurement of signal stability
201.12.1.101.7 RESPONSE TIME
The RESPONSE TIME of the ME EQUIPMENT shall be given as the rise time or fall time for the step
response, which is given as the interval between the times corresponding to 10 % and 90 %
of the step response amplitude during the transition (see Figure 201.106).
The RESPONSE TIME shall be measured and disclosed in the instructions for use.
Compliance is checked by inspection of the instructions for use and the following test.
Shutter closed
6 6
Shutter open
6 6
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
5 DETECTOR PROBE
6 Attenuator
7 Shutter
8 FUNCTIONAL NIRS PHANTOM
NOTE Shutter closed: OPTICAL LOSS: ∞ , shutter open: OPTICAL LOSS: > 40 dB
Figure 201.105 – Measurement of RESPONSE TIME
a) Set up the ME EQUIPMENT, an optical shutter and two attenuators as shown in Figure
201.105 and described in Annex BB.3.3.
b) Measure the rise time or fall time of the step response of the PATHLENGTH-DEPENDENT
HAEMOGLOBIN CHANGE signal caused by the shutter movement as shown in Figure 201.106.
– 18 – IEC 80601-2-71:2015 © IEC 2015
Fall time
Rise time
Time
IEC
Figure 201.106 – Rise time and fall time in RESPONSE TIME
201.12.1.101.8 *Signal-to-noise ratio
The signal-to-noise ratio and the maximum sampling rate of the ME EQUIPMENT shall be
measured and disclosed in the instructions for use.
Compliance is checked by inspection of the instructions for use and the following test.
Amplitude
10 %
90 %
100 %
State A
6 6
State B
6 6
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
5 DETECTOR PROBE
6 Attenuator
8 FUNCTIONAL NIRS PHANTOM
9 Changeable aperture
NOTE State A OPTICAL LOSS: > 60 dB;
NOTE State B OPTICAL LOSS: 3 dB to 4 dB larger than OPTICAL LOSS at state A
Figure 201.107 – Measurement of signal-to-noise ratio
a) Set up the optical system that consists of the ME EQUIPMENT, an optical aperture and two
attenuators as shown in Figure 201.107 and described in BB.3.3.
b) The attenuator OPTICAL LOSS, including the loss by the optical aperture and an additional
optical neutral density filter, shall be more than 60 dB (state A). The change in the
diameter of the optical aperture shall increase the loss by 3 dB to 4 dB (state B), which
induces signal change in the ME EQUIPMENT. The OPTICAL LOSS is measured and adjusted
as described in Annex BB.3.2.
c) The signal change of the ME EQUIPMENT shall be measured at 10 or more sampling events
by 4 or more repetitions with the highest sampling rate of the ME EQUIPMENT.
d) The signal-to-noise ratio of the ME EQUIPMENT that is denoted as S/δS, is the ratio of the
signal change S produced by changing the optical aperture in the optical system to the
standard deviation of the signal variation δS. The signal values S and S , which denote
A B
the signal at state A and at state B respectively, are measured and calculated from the
following.
– 20 – IEC 80601-2-71:2015 © IEC 2015
n m
(∆ c ⋅ L) – ∆ c ⋅ L
∑ ∑
j,A B
i=1 j =1
δS =
m ⋅ n – 1
S = S – S
A B
m
(∆ c ⋅ L)
∑ j,A
j =1
where S = ∆ c ⋅ L = ,
A
A
m
m
(∆ c ⋅ L)
∑ j,B
j =1
S = ∆ c ⋅ L = ,
B
B
m
where m is the number of sampling events and n is the number of repetitions.
e) The PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGES, PATHLENGTH-DEPENDENT
OXYHAEMOGLOBIN CHANGE and PATHLENGTH-DEPENDENT DEOXYHAEMOGLOBIN CHANGE shall
be obtained from the measurement.
201.12.1.101.9 SIGNAL CROSS-TALK
If the ME EQUIPMENT has more than one MEASUREMENT CHANNEL, the SIGNAL CROSS-TALK of the
ME EQUIPMENT shall be measured and disclosed in the instructions for use. The SIGNAL CROSS-
TALK is affected by the spatial arrangement of the EMITTER PROBES and DETECTOR PROBES as
well as the time-varying emissions by individual light sources. These combinations of each
light source and spatial arrangements shall be included in this disclosure of SIGNAL CROSS-
TALK.
NOTE There may be sources of SIGNAL CROSS-TALK internal to the ME EQUIPMENT which can affect these
systematic measures of SIGNAL CROSS-TALK described in the testing below. The device may need shielding and
filtering of channels to prevent these sources from impacting the output.
Compliance is checked by inspection of the instructions for use and the following test.
a) Set up the ME EQUIPMENT and an attenuator as shown in Figure 201.108. Arrangement and
separations between EMITTER PROBES and DETECTOR PROBES are set for NORMAL USE and
shall be disclosed.
b) The attenuator shall be made of scattering and absorbing materials which have OPTICAL
LOSS of more than 40 dB.
c) Operate the ME EQUIPMENT in accordance with its instructions for use.
d) The SIGNAL CROSS-TALK XT is represented as follows:
XT = 20 log V /V
10 0
where V is the voltage of the detector of the relevant channel as measured for each
wavelength from the relevant EMITTER PROBE, proportional to the optical intensity detected
with regard to operation according to the instructions for use and V is the one received in
the condition of no optical emission from the EMITTER PROBE of the relevant channel.
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
5 DETECTOR PROBE
6 Attenuator
NOTE Attenuator OPTICAL LOSS for this test: > 40 dB
Figure 201.108 – Measurement of SIGNAL CROSS-TALK
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
Clause 13 of the general standard applies.
201.14
...
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
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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
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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
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
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.
This bilingual version (2018-11) corresponds to the monolingual English version, published in
2015-06.
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.
The French version of this standard has not been voted upon.
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 Annex AA.
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.
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.
– 6 – IEC 80601-2-71:2015 © IEC 2015
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.
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
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.
—————————
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.
– 8 – IEC 80601-2-71:2015 © IEC 2015
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.
—————————
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.
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.
– 10 – IEC 80601-2-71:2015 © IEC 2015
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
PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE and the
the measured value of the pseudo
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
EMITTER PROBE and a DETECTOR PROBE that provide an output
combination of an
201.3.209
OPTICAL LOSS
ratio of the total optical power exiting the FUNCTIONAL NIRS PHANTOM or attenuator through a
EMITTER PROBE connected to the
specified aperture, to the optical power emitted by the
FUNCTIONAL NIRS MONITOR
Power
3 dB
–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
MEASUREMENT CHANNEL(s) to the relevant
signal contamination or interference from the other
channel in multiple channel equipment
– 12 – IEC 80601-2-71:2015 © IEC 2015
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
For the purposes of this standard, FUNCTIONAL NIRS EQUIPMENT is considered not to have
ESSENTIAL PERFORMANCE. Notwithstanding this fact, when this standard refers to ESSENTIAL
PERFORMANCE as an acceptance criterion, the AVERAGE OPTICAL POWER shall be evaluated.
Subclause 201.12.1.101.2 indicates a method of evaluating AVERAGE OPTICAL POWER as
acceptance criterion following specific tests required by this standard.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts
The marking on the ME EQUIPMENT shall be clearly legible and shall include its classification as
specified in Clause 7 of IEC 60825-1:2014.
201.7.9 ACCOMPANYING DOCUMENTS
Additional subclause:
201.7.9.2.101 Additional requirements for instructions for use
The performances specified in 201.12.1.101 shall be disclosed in the instructions for use.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.3 Classification of APPLIED PARTS
Additional subclause:
201.8.3.101 Additional requirements for classification of APPLIED PARTS
PPLIED PARTS of FUNCTIONAL NIRS EQUIPMENT shall be TYPE BF or TYPE CF APPLIED PARTS.
A
Compliance is checked by inspection.
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME
SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other hazards
Clause 11 of the general standard applies.
201.12 ACCURACY of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Additional subclauses:
201.12.1.101 Performance of FUNCTIONAL NIRS EQUIPMENT
201.12.1.101.1 General
In the following performance test items, if there are multiple EMITTER PROBES and DETECTOR
PROBES, combinations of EMITTER PROBES and DETECTOR PROBES should be selected according
to RISK MANAGEMENT defined by each MANUFACTURER. The selected combinations shall be
recorded.
The FUNCTIONAL NIRS PHANTOM and the attenuator consisting of scattering and absorbing
materials with the required OPTICAL LOSS shall be used for testing the performance of
FUNCTIONAL NIRS EQUIPMENT as shown in Table 201.101.
Table 201.101 – Performance tests employing the FUNCTIONAL
NIRS PHANTOM or attenuator and the required OPTICAL LOSS
FUNCTIONAL
Performance Attenuator OPTICAL LOSS
NIRS PHANTOM
PATHLENGTH-DEPENDENT HAEMOGLOBIN State A: > 40 dB, state B: 3 dB to 4 dB
✔
CHANGE larger than in state A
Signal stability ✔ > 40 dB
State A: > 40 dB, state B: 3 dB to
RESPONSE TIME ✔
4 dB larger than in state A
State A: > 60 dB, state B: 3 dB to
Signal-to-noise ratio ✔
4 dB larger than in state A
– 14 – IEC 80601-2-71:2015 © IEC 2015
FUNCTIONAL
Performance Attenuator OPTICAL LOSS
NIRS PHANTOM
SIGNAL CROSS-TALK ✔ > 40 dB
NOTE 1 The FUNCTIONAL NIRS PHANTOM can also be used as an attenuator with the same OPTICAL LOSS.
NOTE 2 For the measurement of signal-to-noise ratio, the FUNCTIONAL NIRS PHANTOM with > 40 dB can be used,
with an appropriate neutral density filter added.
201.12.1.101.2 AVERAGE OPTICAL POWER
The AVERAGE OPTICAL POWER of the ME EQUIPMENT shall be measured for each EMITTER PROBE
and for each light source and disclosed in the instructions for use.
1 3
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
3 Power Meter
Figure 201.102 – Measurement of AVERAGE OPTICAL POWER
Compliance is checked by inspection of the instructions for use and the following test.
a) Set up the ME EQUIPMENT and power meter and indicators shown in Figure 201.102.
b) Confirm that the size of effective light-receiving area is sufficiently larger than the beam
size on the area. If not, the beam should be made convergent using a suitable adjunct
EMITTER PROBE.
optical element. A suitable adapter should be used to appropriately fix the
c) Measure the AVERAGE OPTICAL POWER with the detector of the power meter and verify that
the value is within the limit specified by the maximum permissible exposure (MPE) of skin
(IEC 60825-1:2014).
EAK WAVELENGTH
201.12.1.101.3 P
The PEAK WAVELENGTHS of the ME EQUIPMENT shall be measured and disclosed in the
instructions for use.
1 4
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
4 Spectrophotometer or optical spectrum analyzer
Figure 201.103 – Measurement of PEAK WAVELENGTH and FWHM
Compliance is checked by inspection of the instructions for use and the following test.
a) Set up the ME EQUIPMENT, a spectrophotometer or an optical spectrum analyzer and an
indicator as shown in Figure 201.103.
b) Measure the wavelength with the spectrophotometer or an optical spectrum analyzer and
verify that the value is within the specified limit.
c) If the channel of the ME EQUIPMENT has more than one light source, the measurement shall
be performed for each light source.
201.12.1.101.4 FULL WIDTH AT HALF MAXIMUM OF SPECTRAL DISTRIBUTION
The FWHM of the spectral distribution shall be measured and disclosed in the instructions for
use for each light source.
Compliance is checked by inspection of the instructions for use and the following test.
a) Set up the ME EQUIPMENT, a spectrophotometer or an optical spectrum analyzer and an
indicator as shown in Figure 201.103.
b) Measure the spectral distribution of the output of the ME EQUIPMENT with the
spectrophotometer or optical spectrum analyzer.
c) The FWHM is obtained from the spectral distribution according to the definition in
201.3.204.
d) If the channel of the ME EQUIPMENT has more than one light source, the measurement shall
be performed for each light source.
NOTE The spectral power distribution related to each NOMINAL wavelength of the ME EQUIPMENT is considered
separately.
201.12.1.101.5 PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE
The PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE shall be measured and disclosed in the
instructions for use.
Compliance is checked by inspection of the instructions for use and the test described in
Annex BB.
201.12.1.101.6 Signal stability
The signal stability of the ME EQUIPMENT shall be measured and disclosed in the instructions
for use.
Compliance is checked by inspection of the instructions for use and the following test.
– 16 – IEC 80601-2-71:2015 © IEC 2015
a) Set up the ME EQUIPMENT by selecting an EMITTER PROBE, a DETECTOR PROBE, and an
attenuator as shown in Figure 201.104
b) The attenuator is made of optical filter or scattering attenuating material that has more
OPTICAL LOSS for each applicable wavelength. The OPTICAL LOSS is measured in
than 40 dB
advance with an optical power meter or, in case of an optical filter, with a
spectrophotometer.
c) Turn on the mains power switches of all the instruments and wait until the instruments
warm up sufficiently if necessary.
d) Set the power of ME EQUIPMENT to the maximum level.
PATHLENGTH-DEPENDENT HAEMOGLOBIN CHANGE as a time series
e) Obtain data samples of the
for more than 15 min and PROCESS with a filter which has a time constant of less than 5 s.
f) Calculate signal stability, S , for oxyhaemoglobin and deoxyhaemoglobin
stab
g) The signal stability, S , is given by the following formula.
stab
k
(∆ c ⋅ L) – ∆ c ⋅ L
∑
j
j =1
S =
stab
k – 1
k
(∆ c ⋅ L)
∑
j
j =1
where ∆ c ⋅ L = and k denotes the number of samples in a time series.
k
NOTE ∆ c ⋅ L is related to the change from the baseline sample, not a change in the attenuation.
The larger value of the S for oxyhaemoglobin and deoxyhaemoglobin is taken as the
stab
signal stability.
2 5
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
5 DETECTOR PROBE
6 Attenuator
NOTE Attenuator OPTICAL LOSS for this test: > 40 dB
Figure 201.104 – Measurement of signal stability
201.12.1.101.7 RESPONSE TIME
The RESPONSE TIME of the ME EQUIPMENT shall be given as the rise time or fall time for the step
response, which is given as the interval between the times corresponding to 10 % and 90 %
of the step response amplitude during the transition (see Figure 201.106).
The RESPONSE TIME shall be measured and disclosed in the instructions for use.
Compliance is checked by inspection of the instructions for use and the following test.
Shutter closed
6 6 5
Shutter open
6 6
IEC
Key
UNCTIONAL NIRS MONITOR
1 F
2 EMITTER PROBE
5 DETECTOR PROBE
6 Attenuator
7 Shutter
8 FUNCTIONAL NIRS PHANTOM
NOTE Shutter closed: OPTICAL LOSS: ∞ , shutter open: OPTICAL LOSS: > 40 dB
Figure 201.105 – Measurement of RESPONSE TIME
a) Set up the ME EQUIPMENT, an optical shutter and two attenuators as shown in Figure
201.105 and described in Annex BB.3.3.
b) Measure the rise time or fall time of the step response of the PATHLENGTH-DEPENDENT
HAEMOGLOBIN CHANGE signal caused by the shutter movement as shown in Figure 201.106.
– 18 – IEC 80601-2-71:2015 © IEC 2015
Fall time
Rise time
Time
IEC
Figure 201.106 – Rise time and fall time in RESPONSE TIME
201.12.1.101.8 *Signal-to-noise ratio
The signal-to-noise ratio and the maximum sampling rate of the ME EQUIPMENT shall be
measured and disclosed in the instructions for use.
Compliance is checked by inspection of the instructions for use and the following test.
Amplitude
10 %
90 %
100 %
State A
6 6 5
State B
6 6
IEC
Key
1 FUNCTIONAL NIRS MONITOR
2 EMITTER PROBE
ETECTOR PROBE
5 D
6 Attenuator
8 FUNCTIONAL NIRS PHANTOM
9 Changeable aperture
NOTE State A OPTICAL LOSS: > 60 dB;
NOTE State B OPTICAL LOSS: 3 dB to 4 dB larger than OPTICAL LOSS at state A
Figure 201.107 – Measurement of signal-to-noise ratio
a) Set up the optical system that consists of the ME EQUIPMENT, an optical aperture and two
attenuators as shown in Figure 201.107 and described in BB.3.3.
b) The attenuator OPTICAL LOSS, including the loss by the optical aperture and an additional
optical neutral density filter, shall be more than 60 dB (state A). The change in the
diameter of the optic
...
Frequently Asked Questions
IEC 80601-2-71:2015 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment". This standard covers: 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.
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.
IEC 80601-2-71:2015 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 80601-2-71:2015 has the following relationships with other standards: It is inter standard links to IEC 80601-2-71:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase IEC 80601-2-71:2015 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of IEC standards.
The article is about IEC 80601-2-71:2015, a standard that applies to functional near-infrared spectroscopy (NIRS) equipment used in medical settings. The standard focuses on the basic safety and essential performance of the equipment, which can be used for diagnostic purposes either on its own or as part of a larger medical equipment system.
記事のタイトル：IEC 80601-2-71:2015 - 医療用電気機器 - 第2-71部：近赤外分光法（NIRS）機器の基本的な安全性と重要な性能に関する特定要件 記事の内容：IEC 80601-2-71:2015は、医療現場で使用される機能的なNIRS機器の基本的な安全性と重要な性能に適用される規格です。この規格は、MEシステムの一部として、または単独で機能的なNIRS機器の出力を補完的な診断のために生産する目的で使用されるME機器を対象としています。
기사 제목 : IEC 80601-2-71:2015 - 의료용 전기 장비 - 제 2-71 파트: 기능적 근적외선 분광 (NIRS) 장비의 기본 안전 및 핵심 기능에 대한 특수 요구 사항 기사 내용 : IEC 80601-2-71:2015은 기능적 NIRS 장비의 기본 안전 및 핵심 기능에 적용되며, 해당 ME 장비로서, 별도의 진단 목적의 기능적 NIRS 장비 출력물을 생산하기 위해 스스로 사용하거나 ME 시스템의 일부로 사용될 수 있도록 되어있습니다.
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