Full Description

Scope

The intent of this amendment is to (1) clarify further the subject selection of sample size of 45 in the clinical study, (2) look 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 (3) address the issue of motion artifact.

Purpose

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, thereefore, 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.

Abstract

Amendment Standard - Active.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 patienta??s body position and activity level for their applicability to ambulatory patients; and addressing the issues of motion artifact is covered in the amendment.

Product Details

Published: 10/04/2019 ISBN(s): 9781504459853, 9781504461764, 9781504459860 Number of Pages: 31 File Size: 1 file , 3 MB Product Code(s): STD23762, STDPD23762, STDPL23762