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RS ISO 81060-1: 2007
Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type

Abstract

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 labelling, 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 [7].
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.

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 81060-1: 2007	ADOPTED ISO STANDARDS	Manufacturing engineering	45	First Edition	Available