Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications


Importancia y uso:

4.1 This guide is intended to aid device developers and manufacturers in the synthesis and/or the selection of proper commercially available solid polyurethane resins, monomers, or partially reacted polymers, and/or solutions for their applications.

4.2 The polyurethanes covered by this guide may be thermally processable or solutions that can be cast into medical devices or components. They may also be used to coat certain surfaces of a medical device.

Subcomité:

F04.11

Referida por:

F2027-25

Volúmen:

13.01

Número ICS:

11.100.99 (Other standards related to laboratory medicine), 83.080.20 (Thermoplastic materials)

Palabras clave:

diagnosis; implant; medical devices; monitor; polyurethane; surgical devices; thermoplastic polyurethane (TPU);

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Norma
F624

Versión
25

Estatus
Active

Clasificación
Guide

Fecha aprobación
2025-05-15