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ASTM-F1027:2007 Edition

ASTM-F1027:2007 Edition

$44.96

F1027-86(2007) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

Published By Publication Date Number of Pages
ASTM 2007 11
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1.1 This practice describes a procedure to assess the cytotoxic potential of materials for use in the construction of medical materials and devices using human excised donor (HED) tissues and their derived primary cells taken from the orofacial region.

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

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

1.4 Assessment of cytotoxicity is one of several procedures employed in determining the biological response to a material, as recommended in Practice F 748.

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
Terminology
Summary of Practice
2 Significance and Use
Apparatus
Reagents
Human Serum
Cell Growth Factors
Reference ECL Cells
(HED) Cells
Preparation of Specimens
3 Preparation of (ECL) Cultures
Preparation and Maintenance of Primary Human Cells
Ascertaining Minimum Effective Titer of Growth Factor
FIG. 1
4 Reference Control and Materials
Assessment of Biocompatibility of Prosthetic Material
TABLE 1
TABLE 2
5 Validity and Standardization
Report
6 A1. STANDARD DEFINITIONS OF TERMS RELATING TO TISSUE CULTURE TESTING FOR CYTOTOXICITY
A1.1
A1.2 List of Terms
7 A2. PREPARATION OF HUMAN SERUM FOR USE IN CULTURE MEDIUM FOR THE SEPARATION AND PREPARATION OF CELL GROWTH FACTOR
A2.1
A2.2
A2.3
A2.4
A2.5
A3. PRODUCTION OF ALPHA GROWTH FACTOR (AGF)
A3.1
A3.2
A3.3
8 A3.4
A3.5 Identification and Collection of AGF Fractions
FIG. A3.1
TABLE A3.1
TABLE A3.2
TABLE A3.3
9 X1. RATIONALE FOR ASSESSMENT OF CELL GROWTH COMPATIBILITY OF PROSTHETIC MATERIALS AND DEVICES
X1.1
X1.2
X1.3
X1.4 Precedental Use of Adult Human Cell Culture Methods
X1.5
10 REFERENCES
TABLE X1.1

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