ASTM F2901 - 13 - Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

ASTM F2901 - 13

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

Status : Current   Published : January 2013

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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.




Standard NumberASTM F2901 - 13
TitleStandard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
StatusCurrent
Publication Date02 January 2013
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Astrogliosis, Biocompatibility, Microglia, Myelinopathy, Neurodegeneration, Neurotoxicity
ICS11.040.01
PublisherASTM
FormatA4
DeliveryYes
Pages3
File Size68.83 KB
Price£36.00


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