SRPS EN ISO 81060-2:2015

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

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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.