EN 12470-5:2003

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

This Part of EN 12470 specifies the metrological and technical requirements for clinical infra-red (IR) ear thermometers with maximum device for intermittent determination of human body temperature.This European Standard applies to devices that when taking temperatures are powered by a power supply either internal or by mains and that provide an indication of the subject's body temperature through measurement of thermal radiation from all or part of the ear canal.NOTE:Devices designed to measure tympanic membrane temperature only are also covered by this standard.