Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
|Publication Date:||1 January 2007|
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 .
EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement of circulatory system pressures.
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
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. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but also maintenance, service, transport, etc.View Less