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Significance and Use
4.1 The objective of this guide is to recommend a panel of biological tests that can be used in addition to the testing recommended in Practice F748. This guide is designed to detect neurotoxicity caused by medical devices that contact nervous tissue.
4.2 The testing recommendations should be considered for new materials, established materials with different manufacturing methods that could affect nervous tissue response, or materials used in new nervous tissue applications.
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 nervous system tissue or cerebral spinal fluid (CSF).
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1904 Practice for Testing the Biological Responses to Particles in vivo
Other Referenced DocumentsUSP <161> Transfusion and Infusion Assemblies and Similar Medical Devices
ICS Number Code 11.040.01 (Medical equipment in general)
ASTM F2901-13, Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices, ASTM International, West Conshohocken, PA, 2013, www.astm.orgBack to Top