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CEN - EN ISO 81060-1

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

active, Most Current
Organization: CEN
Publication Date: 1 May 2012
Status: active
Page Count: 50
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
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 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 n on-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.

Document History

EN ISO 81060-1
May 1, 2012
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
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...

References

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