ISO 80601-2-85

Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

Body

ISO

Number

ISO 80601-2-85

Editions

2021

FDA recognition no.

17-19

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: - Subclause 201.12.1.101.2 (a) the phrase "or tissue heamoglobin phantom measurements" - Annex EE.2.3.4 (g) the phrase "If sufficient statistical power can be achieved using study inclusion criteria, then"

Scope source: FDA 认可共识标准库

Laboratories covering this standard