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CEI EN 80601-2-59 : 2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
Available format(s)

Hardcopy , PDF

Superseded date

05-22-2020

Language(s)

English, English - Italian

Published date

01-01-2011

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 of
      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
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
201.101 Laboratory accuracy of a screening
        thermograph
201.102 Screening thermograph alarm conditions
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) - CALIBRATION SOURCE
Annex CC (informative) - Reference to the
         essential principles
Bibliography
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EC Directives

Applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of humans under indoor environmental conditions, hereafter referred to as ME EQUIPMENT.

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-227. (06/2011)
DocumentType
Standard
Pages
44
PublisherName
Comitato Elettrotecnico Italiano
Status
Superseded
SupersededBy

Standards Relationship
EN 80601-2-59:2009 Identical
IEC 80601-2-59:2017 Identical

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO/TR 13154:2017 Medical electrical equipment Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
ASTM E 1256 : 2017 : REDLINE Standard Test Methods for Radiation Thermometers (Single Waveband Type)
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
EN 12470-5 : 2003 CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
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
OIML R 141 : 2008 PROCEDURE FOR CALIBRATION AND VERIFICATION OF THE MAIN CHARACTERISTICS OF THERMOGRAPHIC INSTRUMENTS

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