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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
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Published date: 12-01-2013
Publisher: Belgian Standards
1 Scope2 Normative references3 Terms and definitions4 Sample preparation5 Cell lines6 Culture medium7 Preparation of cell stock culture8 Test procedures9 Test report10 Assessment of results
Specifies test procedures to assess the in vitro cytotoxicity of medical devices. Describes the incubation of cultured cells either directly or through diffusion in contact with a device and / or with extracts of a device.
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