Working Group Details
WC-BPM - Wearable Cuffless Blood Pressure Monitors
|IEEE Program Manager|
IEEE Std 1708? establishes a normative definition of wearable cuffless blood pressure (BP) measuring devices and the objective performance evaluation of this kind of device. The standard is independent of the form of the device or the vehicle to which the device is attached or in which it is embedded. The standard is applicable to all types of wearable BP measurement devices including epidermal and unobtrusive BP devices that have different modes of operation (e.g., to measure short-term, long-term, snapshot, continuous, beat(s)-to-beat(s) BP, or BP variability). This standard is, however, limited to evaluation of devices that do not use a cuff during measurement and do not cover evaluation of all sphygmomanometers that are used with an occluding or inflatable cuff for the indirect determination of BP on the upper arm or wrist. This standard provides guidelines for manufacturers to qualify and validate their products, potential purchasers or users to evaluate and select prospective products, and health care professionals to understand the manufacturing practices on wearable BP devices.
Clarifying and furthering the subject selection of the sample size in the clinical study; looking into the results of the validation study with respect to the patient?s body position and activity level for their applicability to ambulatory patients; and addressing the issues of motion artifact is covered in the amendment.