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

ASTM-F2901 - 2013 EDITION - CURRENT
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Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
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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.

Keywords

astrogliosis; biocompatibility; microglia; myelinopathy; neurodegeneration; neurotoxicity; ICS Number Code 11.040.01 (Medical equipment in general)

To find similar documents by ASTM Volume:

13.02 (Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment)

To find similar documents by classification:

11.040.01 (Medical equipment in general)

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Document Number

ASTM-F2901-13

Revision Level

2013 EDITION

Status

Current

Modification Type

Revision

Publication Date

Feb. 15, 2013

Document Type

Guide

Page Count

3 pages

Committee Number

F04.16