IEC 80601-2-71:2015

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
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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.
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combination of the conditions
...