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ASTM International - ASTM F624-09(2015)e1

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

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Organization: ASTM International
Publication Date: 1 March 2015
Status: active
Page Count: 4
ICS Code (Other standards related to laboratory medicine): 11.100.99
ICS Code (Thermoplastic materials): 83.080.20
significance And Use:

4.1 This guide is intended to aid device fabricators in the selection of proper commercially available polyurethane solids and solutions for their application.

4.2 The polyurethanes covered... View More

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 specifications containing minimum required values and tolerances for specific end-use products.

1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed 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.

1.4 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.

1.5 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.

Document History

ASTM F624-09(2015)e1
March 1, 2015
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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...
August 1, 2009
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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...
April 10, 2003
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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...
October 10, 1998
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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...
October 10, 1998
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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...
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