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  • DIN EN ISO 81060-2:2014-10

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVASTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013)

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  03-02-2021

    Language(s):  German, English

    Published date:  01-10-2014

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Abstract - (Show below) - (Hide below)

    This part of ISO 81060 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.

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

    Committee TC 121
    Development Note Supersedes DIN EN 1060-4. (10/2014) DRAFT 2017 issued in August 2017. (08/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Withdrawn
    Supersedes

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

    DIN EN 60601-2-34 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (IEC 60601-2-34:2011)
    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
    VDE 0750-2-30 : 2016 MEDIZINISCHE ELEKTRISCHE GERAETE - TEIL 2-30: BESONDERE FESTLEGUNGEN FUER DIE SICHERHEIT EINSCHLIESSLICH DER WESENTLICHEN LEISTUNGSMERKMALE VON AUTOMATISIERTEN NICHT-INVASIVEN BLUTDRUCKMESSGERAETEN (IEC 80601-2-30:2009 + CORRIGENDUM JAN. 2010 + A1:2013)
    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
    DIN EN 80601-2-30 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009 + CORRIGENDUM JAN. 2010 + A1:2013)
    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
    VDE 0750-2-34 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (IEC 60601-2-34:2011)
    DIN EN ISO 14155:2012-01 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    DIN EN ISO 81060-1:2012-08 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
    VDE 0750-1 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
    DIN EN 60601-1-11 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
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