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ISO 81060-2:2013 ED2

Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type

Apr 18, 2013

General information

99.60     Nov 22, 2018

IEC

TC 62/SC 62D

International Standard

11.040.10  

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Revised

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Scope

ISO 81060-2:2013 specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. ISO 81060-2:2013 is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use. ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 81060-2:2009 ED1

NOW

WITHDRAWN
ISO 81060-2:2013 ED2
99.60 Withdrawal effective
Nov 22, 2018

REVISED BY

PUBLISHED
ISO 81060-2:2018 ED3