• EN 12470-4:2000+A1:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 4: Performance of electrical thermometers for continuous measurement

    Available format(s): 

    Superseded date:  01-10-2012

    Language(s): 

    Published date:  17-06-2009

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Unit
    5 Types of thermometers
    6 Requirements
    7 Test methods
    8 Information supplied by the manufacturer
    Annex A (informative) - Suggested types of testing for the
                            requirements of this standard
    Annex ZA (informative) - Relationship between this European
                             Standard and the Essential
                             Requirements of EU Directive
                             93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    This part of EN 12470 specifies the metrological and technical requirements for electrical thermometers for continuous measurements.This European Standard applies to devices that are operated by an electrical power supply either by mains or internal power sources.The devices can be equipped to accommodate secondary indicators, printing devices, and other auxiliary devices. The metrological requirements for such accessories are not covered by this European Standard.Thermometers intended to measure skin temperatures are not covered by this European Standard.This European Standard does not intend to exclude the use of any device based on other measuring principles that provides an equivalent performance in continuously measuring body temperature.NOTEDevices can have functions which are covered by different parts of EN 12470. In this case, it is the responsibility of the manufacturer to indicate by which part of EN 12470 the function is covered, e.g. electrical thermometer with maximum device and exchangeable temperature probes.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 205
    Development Note 2000 Edition Re-Issued in June 2009 & incorporates AMD 1 2009. (08/2009)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
    ISO 2859-2:1985 Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    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 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    IEC 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
    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)
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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