DIN EN 12470-5:2003-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
Hardcopy , PDF
02-01-2013
English
01-12-2013
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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
|
| Pages |
28
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 12470-5:2003 | Identical |
| BS EN 12470-5:2003 | Identical |
| NF EN 12470-5 : 2003 | Identical |
| UNI EN 12470-5 : 2005 | Identical |
| NBN EN 12470-5 : 2003 | Identical |
| UNE-EN 12470-5:2003 | Identical |
| NEN EN 12470-5 : 2003 | Identical |
| I.S. EN 12470-5:2003 | Identical |
| NS EN 12470-5 : 1ED 2003 | Identical |
| SN EN 12470-5 : 2003 | Identical |
| ISO 2859-2:1985 | Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection |
| 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 |
| 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 |
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