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

SS-EN-ISO-81060-2 - 2014 EDITION - CURRENT


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This part of ISO 81060 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. This part of ISO 81060 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. This part of ISO 81060 covers SPHYGMOMANOMETERS intended for use in all PATIENT populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory BLOOD PRESSURE monitoring, stress testing BLOOD PRESSURE monitoring and BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT for selfmeasurement as well as use in a professional healthcare facility).

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Designation Name

SS-EN ISO 81060-2:2014

Revision Level

2014 EDITION

Status

Current

Publication Date

May 7, 2014

Language(s)

English

Page Count

56

International Equivalent

EN ISO 81060-2:2014(IDT); ISO 81060-2:2013(IDT)