UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

ASTM International - ASTM F813-07(2012)

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

inactive
Buy Now
Organization: ASTM International
Publication Date: 1 October 2012
Status: inactive
Page Count: 5
ICS Code (Medical microbiology): 07.100.10
significance And Use:

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... View More

scope:

1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and 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 cells may be affected by the specific gravity of the test sample, this practice is limited to evaluation of cells outside the perimeter of the overlying test sample.

1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Document History

April 1, 2020
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical...
ASTM F813-07(2012)
October 1, 2012
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical...
February 1, 2007
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
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...
October 10, 2001
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
1.1 This practice describes a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical...
October 10, 2001
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
1.1 This practice describes a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical...
Advertisement