ABSTRACT
The evaluation of immunotoxicity in medical devices as part of their biocompatibility assessment is the subject of the most recently issued ISO 10993, Part 20, with the current revision issued in 2006. Traditionally, and still the case for most skin-only contact devices, simple delayed contact dermal sensitization was adequate for evaluating this endpoint. This is in spite of the fact that the association between implanted or indwelling devices and granuloma formation has been known for some time (Adams, 1983; Black, 1981; Salthouse, 1982; Burkitt et al., 1986; Woodward and Salthouse, 1986; Anderson, 1988; Marchant et al., 1985; Unanue, 1994). However, in the time since 1980, science and records of immunologically based device problems have improved, bringing the adequacy of this approach into question and leading to the current guidance.
