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EN ISO 81060-1:2012 Standard

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  Keywords:

#pressure #blood #used #equipment #part

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN 1060-1:1995 +A2:2009 (EN 1060-2:1995 +A1:2009)".

Anyway is still possible use the "EN 1060-1:1995 +A2:2009 (EN 1060-2:1995 +A1:2009)" until May 31st, 2015

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