1 Scope
This document describes the results of an international interlaboratory study
conducted in 2006 to evaluate the performance of two different test protocols in
terms of the cytotoxic effects in the biological evaluation of medical devices. The
results of these tests were used for the revision of ISO 10993‑5.[2] Furthermore, the
results of these tests were used to estimate the accuracy of these test systems with
living cells to define a threshold what is considered a cytotoxic effect.
NOTE The determination of cytotoxic effects has a high relevance in the biological
evaluation of medical devices; according to ISO 10993‑1[1], it is one of
the very few tests which are proposed to be performed for every kind of
device.