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ASTM F 1027 : 1986 : R2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-01-2002

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.

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.

Committee
F 04
DocumentType
Standard Practice
Pages
11
ProductNote
Reconfirmed 2002
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

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ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)

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