ASTM F813-07(2012)
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared.

1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques.

1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F748.

1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is a well-characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories.

1.6 Since the test sample is not removed at the time of microscopic evaluation and underlying c......

ASTM F813-07(2012) Referenced Document

• ASTM F1027 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
• ASTM F619 Standard Practice for Extraction of Medical Plastics
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

ASTM F813-07(2012) history

• 2020 ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• 2007 ASTM F813-07(2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• 2007 ASTM F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• 2001 ASTM F813-01 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• 2001 ASTM F813-83(1996)e1 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices