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CTA 2127

Characteristics and Requirements for Consumer Pulse Oximetry Monitoring Solutions
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This standard will identify the performance characteristics and requirements relevant to low-risk pulse oximeters for health and wellness applications. This standard does not cover performance requirements or provide operational definitions or terminology used for FDA-regulated medical device pulse oximeters. The terminology provided herein reflects the consensus of the Consumer Technology Association® Health, Fitness and Wellness Technology Committee’s knowledge of terminology used by manufacturers of consumer devices that provide pulse oximetry as a feature as of the time of publication. This standard should not be construed as allinclusive. Furthermore, this standard provides helpful information leveraging other established standards to help consumers, retailers, manufacturers, and other interested parties understand the performance characteristics to minimize consumer risks and confusion related to the use of a consumer pulse oximeter.
SDO CTA: Consumer Technology Association
Document Number 2127
Publication Date May 1, 2025
Language en - English
Page Count 21
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
May 1, 2025 cta_2127 Revision