ASTM-F1027 › Historical Revision Information
Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
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Scope
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 F748.
1.5 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.
Keywords
alpha growth factor (AGF); orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Biocompatibility; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Cell compatibility; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Cell culture; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Facial implants; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Human excised donor cells (HED); orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Implants; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Medical devices; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Mouth; orofacial prosthetic materials/devices-tissue/cell; compatibilityassessment, practice, ; Oral/maxillofacial surgery; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Orofacial materials; orofacial prosthetic materials/devices-tissue/cellcompatibility; assessment, practice, ; Prosthesis; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Tissue compatibility; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ;
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Document Number
ASTM-F1027-86
Revision Level
1986 EDITION
Status
Superseded
Modification Type
Reapproval
Publication Date
Sept. 26, 1986
Document Type
Practice
Page Count
15 pages
Committee Number
F04.16