ASTM F895-84(2001)e1 - 1.1.1995
 
1. Scope

1.1 This test method is appropriate for materials in a variety of shapes and for materials which are not necessarily sterile. This test method would be appropriate in situations where 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 which 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 which 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 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.

 
2. Referenced Documents

F748

Practice for Selecting Generic Biological Test Methods for Materials and Devices

American Type Culture Collection,

(ATCC) Catalogue of Strains II Fourth edition, 1983, is available from American Type Culture Collection, 12031 Parklawn Dr., Rockville, MD 10892. Library of Congress No. 76-640122.

USP Negative Control Plastic

Reference Standard U.S. Pharmacopeia, current edition, Rockville, MD.