1. Scope
1.1 This practice covers the assessment of cellular responses to wear particles and degradation
products from implanted materials that may lead to a cascade of biological responses
resulting in damage to adjacent and 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 correlate with in vivo responses. Since there are many possible and established ways of determining responses,
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 (ranking) different materials. For laboratories
without established protocols, recommendations are given and indicated with an asterisk
(*).