Norm

ASTM F2901-13

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

48,24

Over deze norm

Status Definitief
Aantal pagina's 3
Commissie F04.16
Gepubliceerd op 01-02-2013
Taal Engels

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.

Details

ICS-code 11.040.01
Nederlandse titel Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
Engelse titel Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

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