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  • AAMI ISO 81060-2 : 2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE

    Available format(s):  Hardcopy, PDF

    Superseded date:  05-09-2019

    Language(s):  English

    Published date:  01-01-2013

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of IEC 81060-2:2013
    Foreword
    Introduction
    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

    Abstract - (Show below) - (Hide below)

    Provides 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 WG 07
    Development Note Supersedes AAMI SP10. (11/2009)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    AAMI TIR44 : 2012 NON-INVASIVE BLOOD PRESSURE MOTION ARTIFACT - TESTING AND EVALUATION OF NIBP DEVICE PERFORMANCE IN THE PRESENCE OF MOTION ARTIFACT

    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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