ISO 81060-3

Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type

Body

ISO

Number

ISO 81060-3

Editions

2022

FDA recognition no.

3-188

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: - 4.5.1.b.3 regarding number of subjects (k) and Table 2: Relationship between r and the minimum k depending on the estimated intra-class correlation coefficient - 5.1.4.a (page 16), 5.1.4.b (page 16), and 5.2.4.a regarding acceptance criteria - 5.3.5 regarding acceptance criteria

Scope source: FDA 认可共识标准库

Laboratories covering this standard