ASTM F748

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

Body

ASTM

Number

ASTM F748

Editions

2016、2025

FDA recognition no.

2-244

FDA recognition no.

2-310

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Table 1 Section 6.11, passage "Sterile devices that can be demonstrated as passing either the USP rabbit test or the LAL test are commonly labeled as 'non-pyrogenic' ".

Scope source: FDA 认可共识标准库

Laboratories covering this standard