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  • EN 12470-2:2000+A1:2009

    Current The latest, up-to-date edition.

    Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

    Available format(s): 

    Language(s): 

    Published date:  16-06-2009

    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 Type 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 performance requirements and test methods for phase change-type (dot matrix) thermometers for measuring temperature in body cavities.NOTEA body cavity can be the mouth, rectum or armpit.This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for hypothermia) which owing to their measurement range, scale interval or maximum permissible error do not meet the requirements specified in this Standard.

    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 Current

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

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    ISO/IEC Guide 98:1993 Guide to the expression of uncertainty in measurement (GUM)
    ISO 2859-2:1985 Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN 980:2008 Symbols for use in the labelling of medical devices
    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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