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Last Updated: May 27, 2026
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ASTM F2901-26
Standard Guide for Neurotoxicity Evaluation and Additional Biocompatibility Assessment for Medical Devices Contacting the Nervous System
Standard Guide for Neurotoxicity Evaluation and Additional Biocompatibility Assessment for Medical Devices Contacting the Nervous System
F2901-26
ASTM|F2901-26|en-US
Standard Guide for Neurotoxicity Evaluation and Additional Biocompatibility Assessment for Medical Devices Contacting the Nervous System
Standard
F2901 Standard Guide for Neurotoxicity Evaluation and Additional Biocompatibility Assessment for Medical Devices Contacting the Nervous System>
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BOS Vol. 13.02 Committee F04
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ASTM International
Significance and Use
5.1 The objective of this guide is to recommend biological tests that can be used in addition to the testing recommended in Practice F748 for medical devices contacting the nervous system. This guide is primarily designed to evaluate neurotoxicity caused by medical devices that contact nervous tissue or CSF.
5.2 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.
5.3 Material characterization and manufacturing information can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.
Scope
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 and other assessments that are pertinent for devices contacting central and/or peripheral nervous system tissue or cerebrospinal fluid (CSF). This guide does not describe all relevant biocompatibility endpoint assessments based on the duration and nature of tissue contact of the device and should be used in conjunction with Practice F748.
Note 1: The results of these in vitro and in vivo tests may not correspond to actual human response.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.