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ASTM F2901-19

ASTM F2901-19

Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

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1.1 ,Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748, and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact central and/or peripheral nervous system tissue or cerebral spinal fluid (CSF).

Note 1: ,The results of these in vitro and in vivo tests may not correspond to actual human response.

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