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(E) 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.

Medizinische elektrische Geräte - Teil 2-71: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von funktionalen Oximetriegeräten

Appareils électromédicaux - Partie 2-71: Exigences particulières pour la sécurité de base et les performances essentielles des appareils 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.

Medicinska električna oprema - 2-71. del: Posebne zahteve za osnovno varnost in bistvene lastnosti funkcionalne opreme spektrometra v bližnjem infrardečem spektru (IEC 80601-2-71:2015)

Standard EN-IEC 80601-2-71 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI FUNKCIONALNE OPREME SPEKTOMETRA V BLIŽNJEM INFRARDEČEM SPEKTRU (NIRS), namenjene za samostojno uporabo ali kot del SISTEMA ME, za proizvodnjo izpisa FUNKCIONALNE OPREME NIRS za dodatne diagnostične namene, v nadaljevanju imenovane OPREMA ME. Področje uporabe tega zadevnega standarda ne vključuje: a) dela OPREME ME, ki meri nasičenost hemoglobina s kisikom v mikro-žilah (kapilarah, arteriolah in venulah), če je prisotna; b) opreme tkivnega oksimetra v bližnjem infrardečem spektru (NIRS), ki ni namenjena za pridobivanje izpisa FUNKCIONALNE OPREME NIRS; c) opreme pulznega oksimetra, ki ni namenjena za pridobivanje izpisa FUNKCIONALNE OPREME NIRS. Zahteve za opremo pulznega oksimetra so določene v standardu ISO 80601-2-61; d) frekvenčne in časovne opreme za funkcionalno spektroskopijo v bližnjem infrardečem spektru, ki lahko zahtevajo drugačne preskusne postopke, kot so opredeljeni tukaj; e) FUNKCIONALNE OPREME SPEKTOMETRA V BLIŽNJEM INFRARDEČEM SPEKTRU, ki meri spremembe v koncentraciji drugih kromoforov, ki niso oksi- in deoksihemoglobin, ki lahko zahtevajo drugačne preskusne postopke, kot so opredeljeni tukaj.

General Information

Status
Published
Publication Date
21-Jun-2018
Current Stage
6060 - Document made available
Due Date
22-Jun-2018
Completion Date
22-Jun-2018

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SLOVENSKI STANDARD
SIST EN IEC 80601-2-71:2018
01-september-2018
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLIXQNFLRQDOQHRSUHPHVSHNWURPHWUDYEOLåQMHPLQIUDUGHþHP
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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)
Ta slovenski standard je istoveten z: EN IEC 80601-2-71:2018
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN IEC 80601-2-71:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 80601-2-71:2018
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SIST EN IEC 80601-2-71:2018
EUROPEAN STANDARD EN IEC 80601-2-71
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2018
ICS 11.040.55
English Version
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)
Appareils électromédicaux - Medizinische elektrische Geräte -

Partie 2-71: Exigences particulières pour la sécurité de Teil 2-71: Besondere Festlegungen für die Sicherheit

base et les performances essentielles des appareils einschließlich der wesentlichen Leistungsmerkmale von

d'imagerie spectroscopique proche infrarouge (NIRS) funktionalen Oximetriegeräten

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

This European Standard was approved by CENELEC on 2018-02-28. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,

Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 80601-2-71:2018 E
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SIST EN IEC 80601-2-71:2018
EN IEC 80601-2-71:2018
European foreword

The text of document 62D/1238/FDIS, future edition 1 of IEC 80601-2-71, prepared by

SC 62D "Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice", and SC 3

“Lung ventilators and related equipment” of ISO/TC 121 “Anaesthetic and respiratory equipment” was

submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 80601-2-71:2018.
The following dates are fixed:
(dop) 2018-12-22
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2021-06-22
• latest date by which the national
standards conflicting with the
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 80601-2-71:2015 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards indicated:

IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10.
IEC 60601-1-11:2010 NOTE Harmonized as EN 60601-1-11:2010 (not modified).
Superseded by IEC 60601-1-11:2015.
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SIST EN IEC 80601-2-71:2018
EN IEC 80601-2-71:2018
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies except as follows:
Publication Year Title EN/HD Year
Replacement:
IEC 60601-1-6 - Medical electrical equipment - EN 60601-1-6 -
Part 1-6: General requirements for
basic safety and essential performance
- Collateral standard: Usability
IEC 60825-1 2014 Safety of laser products - EN 60825-1 2014
Part 1: Equipment classification and
requirements
Addition:
IEC 60601-1 - Medical electrical equipment - EN 60601-1 -
Part 1: General requirements for basic
safety and essential performance
ISO 80601-2-61 - Medical electrical equipment - EN ISO 80601-2-61 -
Part 2-61: Particular requirements for
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
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SIST EN IEC 80601-2-71:2018
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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SIST EN IEC 80601-2-71:2018
– 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

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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

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and 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

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

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

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

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.
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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SIST EN IEC 80601-2-71:2018
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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SIST EN IEC 80601-2-71:2018
– 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.
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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
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.
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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.

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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 FU
...

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