ISO 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

Body

ISO

Number

ISO 10993-15

Editions

2019

FDA recognition no.

2-288

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 5.2 second paragraph.

Scope source: FDA 认可共识标准库

Laboratories covering this standard