I.S. EN 12470-5:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
24-10-2012
English
01-01-2003
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
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