IEEE 1708

Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]

Body

IEEE

Number

IEEE 1708

Editions

2014

FDA recognition no.

3-168

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 4.2 Observer training and measurement Clause 4.2.2 Observer measurement Clause 4.3.3 e) Special patient populations and confounding factors Clause 4.4.3 Test with blood pressure change Table 2 of Clause 4.4.3 Test with blood pressure change Clause 4.4.4 Test after a certain period of time Clause 4.5.3.2 Accuracy at different BP change levels Clause 7 Communication

Scope source: FDA 认可共识标准库

Laboratories covering this standard