Recognized standard

F624-25

FDA recognition 8-646 · ASTM · Materials

Key facts

Recognition number 8-646
Designation F624-25
Title Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications
Standards developer ASTM International
Specialty area Materials
Date of entry Dec 22, 2025
Scope (excerpt) 1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution forms for medical applications. The polymers have been reacted to completion and require no further chemical processing. 1.2 The tests and methods listed in this guide may be referenced in specifications…

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  • None Product codes
  • 1–9 FDA guidance documents

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