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Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM F895-25
| contributor author | ASTM - ASTM International | |
| date accessioned | 2025-09-30T19:19:08Z | |
| date available | 2025-09-30T19:19:08Z | |
| date copyright | 2025 | |
| date issued | 2025 | |
| identifier other | f0895-25.pdf | |
| identifier uri | https://yse.yabesh.ir/std/handle/yse/342800 | |
| description abstract | 4.1 This test method is useful for assessing the cytotoxic potential of new materials and formulations and as part of a quality control program for established medical devices and components. 4.2 This test method assumes that assessment of cytotoxicity provides useful information to aid in predicting the potential for cytotoxicity including necrotic reactions to medical materials and devices during clinical applications in humans. Cell culture methods have shown good correlation with animal assays when only chemical toxicities are being considered and are frequently more sensitive to cytotoxic agents. 4.3 Some biomaterials with a history of safe clinical use in medical devices are cytotoxic. This test method does not imply that all biomaterials must pass this assay to be considered safe for clinical use (Practice F748). | |
| language | English | |
| title | Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity | en |
| title | ASTM F895-25 | num |
| type | standard | |
| status | Active | |
| tree | ASTM - ASTM International:;2025 | |
| contenttype | fulltext | |
| scope | 1.1 This qualitative test method is appropriate for materials in a variety of shapes. This test method would be appropriate in situations in which the amount of material is limited. For example, small devices could be placed on the agar and the presence of a zone of inhibition of cell growth could be examined, if the chemicals from the test sample can diffuse through the agar layer. 1.1.1 This test method is not appropriate for chemicals that do not diffuse through agar or agarose, or chemicals that interact with the agar or agarose layer. 1.1.2 While 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. 1.2 The 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. 1.3 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. | |
| identifier DOI | 10.1520/F0895-25 |
