ASTM F1027-86(2007)
Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
- Standard No.
- ASTM F1027-86(2007)
- Release Date
- 1986
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F1027-86(2012)
- Latest
- ASTM F1027-86(2017)
- Scope
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.
This practice is used for assessing the cytotoxic potential of materials intended for the fabrication of inserts or implants in the orofacial region.
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.
This practice incorporates procedures to monitor the quality of ingredient materials and the uniformity of the production process for formulating stock compositions.
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.
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.
ASTM F1027-86(2007) 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- ASTM F604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)*， 2017-08-16 Update
- ASTM F703 Standard Specification for Implantable Breast Prostheses*， 1996-04-19 Update
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices*， 1998-04-19 Update
- ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices*， 2001-10-10 Update
ASTM F1027-86(2007) history
- 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
