BS EN ISO 81060-2:2019+A1:2020
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Non-invasive sphygmomanometers Clinical investigation of intermittent automated measurement type
Hardcopy , PDF
04-04-2024
English
18-09-2020
Committee |
CH/205/10
|
DocumentType |
Standard
|
Pages |
48
|
PublisherName |
British Standards Institution
|
Status |
Withdrawn
|
Supersedes |
This document specifies the requirements and methods for the clinical investigation of meequipment 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 IEC80601‑2‑30 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 ISO81060‑1 or invasive blood pressure monitoring equipment as given in IEC60601‑2‑34.
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