ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Body

ISO

Number

ISO 10993-13

Editions

2010

FDA recognition no.

2-169

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 4.1.1 Clause 5.3.4.2 Figure 1

Scope source: FDA 认可共识标准库

Laboratories covering this standard