ASTM F2901 - 13

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

    Active Standard ASTM F2901 | Developed by Subcommittee: F04.16

    Book of Standards Volume: 13.02


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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.

    4.3 Chemical characterization can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.

    1. 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. 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).

    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.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    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 Documents

    USP<161> Transfusion and Infusion Assemblies and Similar Medical Devices


    ICS Code

    ICS Number Code 11.040.01 (Medical equipment in general)

    UNSPSC Code

    UNSPSC Code


    DOI: 10.1520/F2901-13

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