ASTM F2901-19 PDF

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 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. 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.

ASTM F2901-19 Referenced Document

ANSI/AAMI ST72
ASTM F1904 Standard Practice for Testing the Biological Responses to Particles In Vivo
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

2019 ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
2013 ASTM F2901-13 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
2012 ASTM F2901-12 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices