1. Scope
1.1 This guide recommends generic test methods for medical devices that contact neural tissue or cerebral spinal fluid. Medical devices may cause adverse effects on the structure or function of the nervous system. These adverse effects, defined as neurotoxicity, may be detected using an appropriate panel of in-vitro and in-vivo test methods. This guide should be used in addition to Practice F748. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywords
neurotoxicity; biocompatibility; neuroinflammation; neurodegeneration; myelinopathy; astrogliosis
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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