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Full Description

This standard specifies the requirements and methods for the clinical validation of medical electrical equipment used for the intermittent non-invasive automatic estimation of the arterial blood pressure by utilizing a cuff. It 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. This standard covers sphygmomanometers intended for use in all patient populations (i.e. all age and weight ranges, and all conditions of use, e.g., ambulatory blood pressure monitoring, stress testing blood pressure monitoring). It is also applicable to the validation of electronically-controlled intermittent noninvasive blood pressure measurement medical electrical equipment, including blood pressure monitors for the home healthcare environment or self-measurement.
 

Document History

  1. AAMI/ISO 81060-2:2019


    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

    • Most Recent
  2. AAMI/ISO 81060-2:2013

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    Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

    • Historical Version
  3. AAMI/ISO 81060-2:2009


    Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

    • Historical Version
  4. AAMI SP10:2002/A1:2003/(R)2008/A2:2006/(R)2008


    Manual, Electronic or Automated Sphygmomanometers

    • Historical Version
  5. AAMI SP10:2002/(R)2008


    Manual, Electronic or Automated Sphygmomanometers

    • Historical Version
  6. AAMI SP10-92


    Electronic or Automated Sphygmomanometers

    • Historical Version