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Current Reaffirmation

CSA ISO 81060-2:19 (R2024)

Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (Adopted ISO 81060-2:2018, third edition, 2018-11)
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Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (Adopted ISO 81060-2:2018, third edition, 2018-11)
Scope

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.

SDO CSA: Canadian Standards Association
Document Number
Publication Date Jan. 1, 2019
Language en - English
Page Count 53
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Jan. 1, 2019 CSA ISO 81060-2:19 (R2024) Reaffirmation
Jan. 1, 2019 CSA ISO 81060-2:F19 (C2024) Reaffirmation