ISO 81060-2

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]

Body

ISO

Number

ISO 81060-2

Editions

2018

FDA recognition no.

3-196

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 5.1.6 b) Special patient populations. Examples 3 & 6 of Clause 5.2.4.1.2 Data analysis. Examples 3 & 6 of Clause 5.2.4.2.2 Data analysis. Clause 6.1.6 b) Special patient populations. Clause 6.2.4 c) Determining the reference blood pressure. Clause 7 Pregnant patient populations.

Scope source: FDA 认可共识标准库

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