Full Description

1.1This 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.

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

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

1.4Assessment of cytotoxicity is one of several procedures employed in determining the biological response to a material, as recommended in Practice F748.

1.5This 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.

1.6This 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.