ASTM F 1027 : 1986 : R2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
Hardcopy , PDF
11-11-2014
English
01-02-2007
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 13.01, 2017 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.
| Committee |
F 04
|
| DocumentType |
Standard Practice
|
| Pages |
11
|
| ProductNote |
Reconfirmed 2007
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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 F 813 : 2007 : R2012 | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| ASTM F 748 : 2016 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM F 604 : 1994 | Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
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