Standard: AAMI 81060-1
NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NONAUTOMATED MEASUREMENT TYPE
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This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11, and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.
This part of ISO 81060 specifies requirements for the safety and essential performance, including effectiveness and labeling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement.
The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.
EXAMPLE 1 A stethoscope for detecting Korotkoff sounds, Doppler ultrasound or other manual methods.
Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressure sensing elements and/or displays used in conjunction with other automatic methods determining blood pressure are specified in IEC 60601-2-30.
Requirements for invasive blood pressure measurement equipment that directly measure blood pressure are specified in document IEC 60601-2-34.
EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement of circulatory system pressures.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 81060-1|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|AAMI 81060-1||Change Type: STCH||Update Date: 2007-01-01||Revision: 07||Status: ACTV|