Significance and Use
5.1 This practice is useful for assessing the cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical devices.
5.2 This practice is used for assessing the cytotoxic potential of materials intended for the fabrication of inserts or implants in the orofacial region.
5.3 This practice is restricted to normal non-transformed, human orofacial tissues using cells cultured in human serum factors and does not depend upon cells and serum from non-human sources.
5.4 This practice incorporates procedures to monitor the quality of ingredient materials and the uniformity of the production process for formulating stock compositions.
5.5 This practice may be useful to determine the effects of age and radiation, and the state of carcinogenicity on the sensitivity of HED tissues to materials and devices used for orofacial prostheses.
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.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
