GSO ASTM F2901:2021
Gulf Standard
Current Edition
·
Approved on
01 July 2021
·
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
GSO ASTM F2901:2021 Files
English
3 Pages
Current Edition
Reference Language
GSO ASTM F2901:2021 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.
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