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ASTM International - ASTM F813-83(1996)e1

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

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Organization: ASTM International
Publication Date: 10 October 2001
Status: inactive
Page Count: 4
ICS Code (Medical microbiology): 07.100.10
scope:

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 materials and devices.

1.2 This method 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 F 748.

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 an established cell line, well-characterized and readily available, that has demonstrated reproducible results in several laboratories.

1.6 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
1.1Â 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...
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...
ASTM F813-83(1996)e1
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...
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