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

Importancia y uso:

4.1 The objective of this guide is to recommend a panel of biological tests that can be used in addition to the testing recommended in Practice F748. This guide is designed to detect neurotoxicity caused by medical devices that contact nervous tissue.

4.2 The testing recommendations should be considered for new materials, established materials with different manufacturing methods that could affect nervous tissue response, or materials used in new nervous tissue applications.

4.3 Chemical characterization can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.

Subcomité:

F04.16

Referida por:

E3219-20

Volúmen:

13.02

Número ICS:

11.040.01 (Medical equipment in general)

Palabras clave:

astrogliosis; biocompatibility; microglia; myelinopathy; neurodegeneration; neurotoxicity;