Statistical considerations for testing automated sphygmomanometers in special patient populations-Reference-Cited by-同舟云学术

Statistical considerations for testing automated sphygmomanometers in special patient populations

Published:2023-04-04 Issue:3 Volume:28 Page:167-170
ISSN:1359-5237
Container-title:Blood Pressure Monitoring
language:en
Short-container-title:

Author:

Alpert Bruce S.¹,Matsumura Paul²,Wu Colin O.³,Friedman Bruce⁴,Flotzinger Doris⁵,Osborn David⁶

Affiliation:

1. Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee

2. SunTech Medical, Inc., Morrisville, North Carolina

3. Division of Intramural Research, National Heart Lung and Blood Institute, Bethesda, Maryland

4. Independent Consultant, Big Canoe, Georgia, USA

5. CNSystems Medizintechnik GmbH, Graz, Austria

6. Philips, Salem, New Hampshire, USA

Abstract

The International Standards Organization 81060-2:2018 is the current global Standard for the validation of automated sphygmomanometers. It specifies the requirements for clinical studies on the general population, as well as additional requirements for special populations, which might have physiologic characteristics that affect the accuracy of blood pressure measurements. This paper summarizes the statistical methodology behind the sample size required to test automated sphygmomanometers in these special populations and specifically addresses the pregnant patient population.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Assessment and Diagnosis,Cardiology and Cardiovascular Medicine,General Medicine,Internal Medicine

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