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EN ISO 81060-2:2014

Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013) EN ISO 81060-2:2014

Publication date:   Jul 17, 2014

General information

99.60 Withdrawal effective   Nov 27, 2019

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

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Life cycle

PREVIOUSLY

WITHDRAWN
EN 1060-4:2004

NOW

WITHDRAWN
EN ISO 81060-2:2014
99.60 Withdrawal effective
Nov 27, 2019

REVISED BY

PUBLISHED
EN ISO 81060-2:2019

Relations

Adopted from ISO 81060-2:2013 IDENTICAL