This National Standard of Canada is equivalent to International Standard ISO 10993-5:1992. 1 Scope This part of ISO 10993 describes test methods to assess the in vitro
cytotoxicity of medical devices. NOTE 1 The term medical devices corresponds to the definition given in ISo
10993-1 and covers medical materials as well as dental material and devices.
The definition is in accordance with the CEN standard document. These methods specify the incubation of cultured cells either directly or
through diffusion a) with extracts of the device, and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian
cells in vitro using appropriate biological parameters.