T/FDSA 0124-2026 Wearable sleeveless blood pressure measurement device

Scope

This document applies to all types of wearable, cuffless blood pressure measurement devices intended for use in medical institutions and/or in home and personal settings, including watches, wristbands, rings, patches, clothing, and measurement instruments and modules embedded in furniture or environments. It is not limited to a single working mode and covers a variety of blood pressure monitoring forms: snapshot-type blood pressure continuous beat-by-beat blood pressure continuous waveform of blood pressure graphs static, long-term, and dynamic change monitoring classification of blood pressure in different states blood pressure variability It should be noted that this document is only used to evaluate devices that do not use cuffs during measurement, and is not suitable for evaluating all blood pressure meters that perform indirect blood pressure measurement through blocking or inflatable cuffs (such as traditional oscillometric blood pressure meters).

Development Information

Related Standards