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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BS EN ISO 1833‑13:2019 includes some technical changes compared to ISO 1833-10:2010

it supersedes BS EN 81-1:1998+A3:2009 and BS EN 81-2:1998+A3:2009

Why should you use BS AU 214a-1 - Type T gearbox flanges for commercial vehicles and buses

BS EN 12168 provides guidance on designations

ISO 19453‑6 specifies requirements for lithium-ion traction battery packs or systems used in battery electric

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NOTE 1 Where relevant

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