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

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, English - French

Published date

06-09-2015

Publisher

International Electrotechnical Committee

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
       and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation HAZARDS
201.11 Protection against excessive temperatures and other hazards
201.12 ACCURACY of controls and instruments and protection against
       hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annexes
Annex C (informative) - Guide to marking and labelling requirements
        for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - Evaluating ME EQUIPMENT performance using the
         FUNCTIONAL NIRS PHANTOM
Annex CC (informative) - Reference to the essential principles
Bibliography
Index of defined terms

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.

DevelopmentNote	Stability date: 2018. (06/2015)
DocumentType	Standard
Pages	37
PublisherName	International Electrotechnical Committee
Status	Current

Standards	Relationship
NF EN IEC 80601-2-71:2018	Identical
SN EN IEC 80601-2-71:2018	Identical
DIN EN IEC 80601-2-71 : 2018-12	Identical
EN IEC 80601-2-71:2018	Identical
SS-EN IEC 80601-2-71:2018	Identical
UNE-EN IEC 80601-2-71:2018	Identical
BS EN IEC 80601-2-71:2018	Identical
VDE 0750-2-71 : 2018-12	Identical

IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-10:2007+AMD1:2013 CSV	Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
IEC 60825-1:2014	Safety of laser products - Part 1: Equipment classification and requirements
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
ISO 80601-2-61:2011	Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

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IEC 80601-2-71:2015

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