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ASTM F 813 : 2007 : R2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Direct Contact Cell Culture Evaluation of Materials for Medical Devices
Available format(s)

Hardcopy , PDF

Superseded date

07-31-2020

Language(s)

English

Published date

10-01-2012

CONTAINED IN VOL. 13.01, 2015 Defines direct contact cell culture testing used in determining the cytotoxic potential of materials used in the construction of medical devices and materials.

1.1This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices.

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

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

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

1.5The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is a well-characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories.

1.6Since the test sample is not removed at the time of microscopic evaluation and underlying cells may be affected by the specific gravity of the test sample, this practice is limited to evaluation of cells outside the perimeter of the overlying test sample.

1.7The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.8This 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
5
ProductNote
Reconfirmed 2012
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 1027 : 1986 : R2012 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM F 1027 : 1986 : R1995 : EDT 1 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 1027 : 1986 : R2017 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)
ASTM F 1027 : 1986 : R2007 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM F 1027 : 1986 : R2002 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

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