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  • BS EN ISO 81060-2:2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Non-invasive sphygmomanometers Clinical investigation of automated measurement type

    Available format(s):  Hardcopy, PDF

    Superseded date:  18-09-2020

    Language(s):  English

    Published date:  30-06-2014

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements for CLINICAL INVESTIGATIONS
    5 CLINICAL INVESTIGATION with an auscultatory
      REFERENCE SPHYGMOMANOMETER
    6 CLINICAL INVESTIGATION with REFERENCE INVASIVE
      BLOOD PRESSURE MONITORING EQUIPMENT
    7 Pregnant (including pre-eclamptic) PATIENT
      populations
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - Target heart rates for
            exercise stress testing
    Annex C (informative) - Reference to the essential
            principles
    Bibliography
    Terminology - Alphabetized index of defined terms
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on medical devices

    Abstract - (Show below) - (Hide below)

    Describes the requirements and methods for the CLINICAL INVESTIGATION of ME EQUIPMENT used for the intermittent non-invasive automated estimation of the arterial BLOOD PRESSURE by utilizing a CUFF.

    Scope - (Show below) - (Hide below)

    ISO 81060-2:2013 specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. ISO 81060-2:2013 is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use. ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.

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

    Committee CH/205
    Development Note Renumbers and supersedes BS ISO 81060-2. 2014 Version incorporates corrigendum to BS ISO 81060-2. Supersedes 08/30174059 DC & BS EN 1060-4. (06/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
    AAMI SP10 : 2002 MANUAL, ELECTRONIC, OR AUTOMATED SPHYGMOMANOMETERS
    EN 1060-4 : 2004 NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    IEC 80601-2-30:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
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