T/CQAE 14004-2021 Smart Non-invasive Health Screening Equipment General Specification

Scope

Scope: This document specifies the requirements, inspection rules, marking, packaging, transportation, and storage for intelligent non-invasive health screening devices, describes the corresponding test methods, and defines related terms and definitions as well as product classification and model marking. This document applies to the design, production, and inspection of intelligent non-invasive health screening devices (hereinafter referred to as "products"). This document does not apply to related medical devices. Main technical content: 3.1 Intelligent non-invasive health screening equipment: A device that can quickly and comprehensively test the health level of various human systems and physiological functions without causing trauma to the tester, early detect sub-healthy areas, their severity, and development trends, and independently conduct comprehensive health assessments and provide health recommendations. 3.2 Index coincidence rate: The ratio of the number of indicators measured by the intelligent non-invasive health screening device (3.1) that are consistent with the comparable indicators of the reference machine [either both normal or both abnormal (either both high or both low)] to the total number of tested indicators.

Development Information

Related Standards