Standard Historical Last Updated: Mar 02, 2021 Track Document
ASTM F624-98a

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

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications F0624-98A ASTM|F0624-98A|en-US Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications Standard new BOS Vol. 13.01 Committee F04
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Scope

1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical 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 specification containing minimum required values and tolerances for specific end use products.

1.3 Test values shall be stated in SI units with inch-pound units in parentheses.

1.4 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be constructed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.

1.5 Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use.

1.6 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.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.11
Pages: 4
DOI: 10.1520/F0624-98A