Wearable, Cuffless Blood Pressure Measuring Devices
|Publication Date:||21 August 2014|
The intent of this standard is to establish objective performance evaluation of wearable, cuffless blood pressure (BP) measuring devices. 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 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 does 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.
There is currently no defined, independent standard for wearable cuffless BP measurement devices, which have drawn growing interest in recent years. Existing standards for evaluating sphygmomanometers are intended only for devices that are used with an occluding cuff and, therefore, do not cover all aspects needed for the emerging wearable devices. 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.