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DIN EN 12470-5:2003-09

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)
Available format(s)

Hardcopy , PDF

Superseded date

02-01-2013

Language(s)

English

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
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
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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