标准编号：ISO 81060-2:2018
中文名称：无创血压计 第2部分：间歇性自动测量型的临床研究
英文名称：Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type
发布日期：2018-11
标准范围
This document 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 document 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 document 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 self-measurement as well as use in a professional healthcare facility).
EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation
according to this document.
This document specifies additional disclosure requirements for the accompanying documents of
sphygmomanometers that have passed a clinical investigation according to this document.
This document is not applicable to clinical investigations of non-automated sphygmomanometers
as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
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