Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 8-646
Standard
ASTM  F624-25
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications
Scope/Abstract
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 containing minimum required values and tolerances for specific end-use products.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions - Guidance for Industry, November 2000.

Annuloplasty Rings 510(k) Submissions - Final Guidance for Industry and FDA Staff, November 1999.

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", September 2023.

MDDT Summary of Evidence and Basis of Qualification for Accelerated Testing to Prove Long Term Material Biostability, March 2023.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Jinrong (Jinny) Liu
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-3160
  jinrong.liu@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
-
-