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Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

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Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents1 Scope This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in on a medical device or released from a medical device. The TTC values in this document can be used for: comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 1099318); supporting toxicological equivalence; comparing to a maximum

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