ASTM F1027-86(2017) PDF

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.

ASTM F1027-86(2017) Referenced Document

ASTM D883 Standard Terminology Relating to Plastics*， 2024-02-01 Update
ASTM F604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
ASTM F703 Standard Specification for Implantable Breast Prostheses
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

2017 ASTM F1027-86(2017) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
1986 ASTM F1027-86(2012) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
1986 ASTM F1027-86(2007) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
1986 ASTM F1027-86(2002) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
1995 ASTM F1027-86(1995)e1 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices