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ASTM F 895 : 2011 : R2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

Available format(s)

Hardcopy , PDF

Superseded date

01-10-2025

Superseded by

ASTM F 895 : 2025

Language(s)

English

Published date

04-01-2016

CONTAINED IN VOL. 13.01, 2016 Defines test method which is appropriate for materials in a variety of shapes and for materials that are not necessarily sterile.

Committee
F 04
DocumentType
Test Method
Pages
5
ProductNote
Reconfirmed 2016
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

1.1This test method is appropriate for materials in a variety of shapes and for materials that are not necessarily sterile. This test method would be appropriate in situations in which the amount of material is limited. For example, small devices or powders could be placed on the agar and the presence of a zone of inhibition of cell growth could be examined.

1.1.1This test method is not appropriate for leachables that do not diffuse through agar or agarose.

1.1.2While the agar layer can act as a cushion to protect the cells from the specimen, there may be materials that are sufficiently heavy to compress the agar and prevent diffusion or to cause mechanical damage to the cells. This test method would not be appropriate for these materials.

1.2The 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 an established cell line, well characterized and readily available, that has demonstrated reproducible results in several laboratories.

1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4This 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.

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ASTM F 748 : 2016 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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ASTM F 2529 : 2013 : R2021 Standard Guide for  <emph type="ital"> in vivo</emph> Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
ASTM F 2695 : 2012 : R2020 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
ASTM F 2347 : 2024 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 813 : 2020 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
ASTM F 2721 : 2009 : R2023 Standard Guide for Preclinical <emph type="ital">in vivo</emph> Evaluation in Critical-Size Segmental Bone Defects
ASTM F 2103 : 2018 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F 2064 : 2017 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
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ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

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