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EN 12470-5 : 2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
Superseded date

10-01-2012

Published date

01-12-2013

Foreword
1 Scope
2 Normative References
3 Terms and definitions
4 Unit
5 Types of thermometers
6 Requirements
  6.1 General
  6.2 Range of displayed temperature
  6.3 Maximum permissible error
  6.4 Environmental requirements
  6.5 Indicating unit
  6.6 Construction
7 Test Methods
  7.1 General
  7.2 Sampling
  7.3 Testing for compliance of the range of displayed
       temperature
  7.4 Testing for compliance of the maximum permissible
       error within ambient operating range
  7.5 Testing for compliance of maximum permissible
       error under extended operating conditions
  7.6 Testing for compliance of maximum permissible
       error under changing environmental conditions
  7.7 Testing for compliance with maximum permissible
       clinical repeatability - Procedure
  7.8 Testing for compliance with the effect of storage
       and long term stability
  7.9 Method of test for mechanical shock
  7.10 Testing for compliance with the variation of the
       supply voltage
  7.11 Testing for compliance with cleaning and
       disinfection
8 Information supplied by the manufacturer
  8.1 General
  8.2 Marking
  8.3 Instruction for use
Annex A (informative) Clinical trial to determine
        clinical accuracy
  A.1 Introduction
  A.2 Clinical accuracy
  A.3 Clinical trial procedure
  A.4 Clinical bias and its standard deviation
  A.5 Clinical repeatability
Annex B (informative) Suggested types of testing for
        the requirements of this standard
Annex C (informative) Example for a suitable design
        of a black body radiator
Annex D (informative) Alternative approaches to prove
        compliance with 6.3
  D.1 General
  D.2 Separation of the maximum permissible error for
       the instrument and for the probe covers
  D.3 Calculation of the error using error propagation
       analysis
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provision of EU Directives
Bibliography

Defines the metrological and technical requirements for clinical infra-red (IR) ear thermometers with maximum device for intermittent determination of human body temperature.

Committee
TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded

CSA C22.2 No. 80601-2-56 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
BS EN ISO 80601-2-56:2017 Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
15/30312454 DC : 0 BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
06/30138608 DC : 0 IEC 60601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
I.S. EN ISO 80601-2-56:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
CSA C22.2 No. 80601-2-59 : 2010 : R2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
07/30168223 DC : 0 BS IEC 80601-2-59 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
UNE-EN ISO 80601-2-56:2013 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
CSA C22.2 No. 80601-2-59 : 2010 : INC : COR 1 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
CSA C22.2 No. 80601-2-59 : 2010FR MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
CEI EN 80601-2-59 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
CSA C22.2 No. 80601-2-56 : 2012 : R2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
I.S. EN 80601-2-59:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING
EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
BS EN 80601-2-59:2009 Medical electrical equipment Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
EN ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
EN 80601-2-59:2009 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 2859-2:1985 Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
IEC 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
EN 980:2008 Symbols for use in the labelling of medical devices
EN 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

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