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Description of ASTM-F895 2011ASTM F895 - 11Standard Test Method for Agar Diffusion Cell Culture Screening for CytotoxicityActive Standard ASTM F895 | Developed by Subcommittee: F04.16 Book of Standards Volume: 13.01 ASTM F895Significance and Use
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. This test method assumes that assessment of cytotoxicity provides useful information to aid in predicting the potential clinical applications in humans. Cell culture methods have shown good correlation with animal assays and are frequently more sensitive to cytotoxic agents. This cell culture test method is suitable for incorporation into specifications and standards for materials to be used in the construction of medical devices that are to be implanted into the human body or placed in contact with tissue fluids or blood on a long-term basis. 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 ). 1. Scope
1.1 This 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. 1.1.1 This test method is not appropriate for leachables that do not diffuse through agar or agarose. 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 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 and health practices and determine the applicability of regulatory limitations prior to use. ASTM Standards F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices ATCC Document USPNegativeControlPl Reference Standard U.S. Pharmacopeia, current edition, Rockville, MD.Keywords agar diffusion; biocompatibility; cell culture; cytotoxicity testing: Biocompatibility; Cell culture; Screen analysis--medical/surgical applications; Agar diffusion; ICS Code ICS Number Code 07.100.10 (Medical microbiology) DOI: 10.1520/F0895-11 ASTM International is a member of CrossRef. ASTM F895This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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