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SN 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

12-01-2012

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.

DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded

Standards Relationship
DIN EN 12470-5:2003-09 Identical
BS EN 12470-5:2003 Identical
EN 12470-5 : 2003 Identical
I.S. EN 12470-5:2003 Identical
UNE-EN 12470-5:2003 Identical

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