EN IEC 80601-2-71:2018

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
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-Jun-2018
• Completion Date: 22-Jun-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN IEC 80601-2-71:2018 - 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)

Relations

• Revised: prEN IEC 80601-2-71:2023 - Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
• Effective Date: 09-Dec-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2018
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLIXQNFLRQDOQHRSUHPHVSHNWURPHWUDYEOLåQMHPLQIUDUGHþHP
VSHNWUX,(&
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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
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.
1)
IEC 60601-1-11:2010 NOTE Harmonized as EN 60601-1-11:2010 (not modified).

1)
Superseded by IEC 60601-1-11:2015.
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

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

IEC 80601-2-71:2015 © IEC 2015 – 3 –
Figure BB.3 – FUNCTIONAL NIRS PHANTOM measurement using the ME EQUIPMENT to be
evaluated . 29
Figure BB.4 – Schematic for measurement of OPTICAL LOSS . 32

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

– 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
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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
mi
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