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ASTM-F813:2007 Edition

ASTM-F813:2007 Edition

$35.75

F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

Published By Publication Date Number of Pages
ASTM 2007 4
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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 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 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.

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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Summary of Practice
Significance and Use
2 Apparatus
Reagents
Cell Cultures
Control Materials
General Technique
Preparation of Specimens
3 Preparation of Cell Layer
Test Procedure
Evaluation of Results
4 Report
Precision and Bias
Keywords
X1. RATIONALE FOR EVALUATING DIRECT CONTACT CELL CULTURE OF MATERIALS FOR MEDICAL DEVICES

X1.1
X1.2
X1.3

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