BH GSO ASTM F2901:2023
Bahraini Standard
Current Edition
·
Approved on
05 April 2023
·
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
BH GSO ASTM F2901:2023 Files
English
0 Pages
Current Edition
Reference Language
BH GSO ASTM F2901:2023 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.
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