Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

Importancia y uso:

4.1 This test method is useful for assessing the cytotoxic potential of new materials and formulations and as part of a quality control program for established medical devices and components.

4.2 This test method assumes that assessment of cytotoxicity provides useful information to aid in predicting the potential for cytotoxicity including necrotic reactions to medical materials and devices during clinical applications in humans. Cell culture methods have shown good correlation with animal assays when only chemical toxicities are being considered and are frequently more sensitive to cytotoxic agents.

4.3 Some biomaterials with a history of safe clinical use in medical devices are cytotoxic. This test method does not imply that all biomaterials must pass this assay to be considered safe for clinical use (Practice F748).

Subcomité:

F04.16

Referida por:

E1299-96R23, F2064-17, F2224-09R20, F2884-21, F0748-16, F2565-21, F2097-23, F2529-13R21, F0451-21, F0641-09R23, F0648-21, F2103-18, F2347-24, F2695-12R20, E2526-22, F2097-23, F0813-20, F2759-19, F2721-09R23, E3219-20, F3089-23, F2212-20

Volúmen:

13.01

Número ICS:

07.100.10 (Medical microbiology)

Palabras clave:

agar diffusion; biocompatibility; cell culture; cytotoxicity testing;