AAMI 81060-1
Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
| Organization: | AAMI |
| Publication Date: | 1 January 2007 |
| Status: | active |
| Page Count: | 54 |
scope:
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
Requirements for invasive blood pressure measurement equipment that directly measure blood pressure are specified in document IEC 60601-2-34 [8].
EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement of circulatory system pressures.
intended Use:
use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer NOTE Intended use should not be confused with normal use.... View More
Document History
