ASTM F 1903 : 2025 : REDLINE

1.1This practice provides considerations for the in vitro assessment of cellular responses to wear particles and degradation products from medical device materials with direct or indirect contact with tissues that may lead to a cascade of biological responses resulting in damage to adjacent and/or remote tissues. In order to ascertain the role of particles in stimulating such responses, the nature of the responses, and the consequences of the responses, established protocols are needed. This is an emerging, rapidly developing area, and the information gained from standard protocols is necessary to interpret cellular responses to particles and to determine if these may be informative of in vivo responses. Since there are many possible and established ways of determining cellular responses to device materials, a single standard protocol is not stated. However, well-described protocols are needed to compare results from different investigators using the same materials and to compare biological responses for evaluating different materials.

1.2Since the purpose of the following test considerations is to predict the response in human tissues, the use of human (preferably macrophage lineage) cells is recommended. However, the use of non-macrophage cell lineage or the use of cells from non-human and non-primate sources may be acceptable. The source of the cells or the cell line used should be justified based on the cellular responses and/or tissue of interest. Non-human cells should not be used if there is evidence of possible cross-species differences for specific test results as the results of in vitro testing may not be informative of the human response of interest.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5This 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.