Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

Importancia y uso:

4.1 This practice is useful for assessing cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical materials and medical devices.

4.2 This practice assumes that assessment of cytotoxicity potential provides one method for predicting the potential for cytotoxic or necrotic reactions to medical materials and devices during clinical applications to humans. In general, cell culture testing methods have shown good correlation with animal assays when only chemical toxicities are being considered.

Note 1: The results obtained using this method may not predict in vivo behavior which can be influenced by multiple factors such as those arising from site of application or physical properties that may result from design and fabrication.

4.3 This cell culture test method is suitable for adoption in specifications and standards for materials for use in the construction of medical devices that are intended to have direct contact with tissue, tissue fluids, or blood. However, care should be taken when testing materials that are absorbable, include an eluting or degradable coating, are liquid or gelatinous in nature, are irregularly shaped solid materials, or have a high density or mass, to make sure that the method is applicable. If leachables from the test sample are capable of diffusing through the agar layer, agarose-based methods such as Test Method F895 may be considered as an alternate method, depending on sample characteristics, or in cases where investigators wish to further evaluate the cytotoxic response of cells underlying the test sample.

Subcomité:

F04.16

Referida por:

F2064-17, F2224-09R20, F0748-16, F2565-21, F2097-23, F0451-21, F0648-21, F2103-18, F2347-24, F2695-12R20, E2526-22, F2097-23, F2759-19, F3206-17, E3219-20, F3089-23, F2212-20

Volúmen:

13.01

Número ICS:

07.100.10 (Medical microbiology)

Palabras clave:

biocompatibility; cell culture; cytotoxicity testing; direct contact cytotoxicity;