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

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.

1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in medical 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 medical device manufacturer must evaluate the biocompatibility of devices that contain the polyurethane of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.

1.4 Material 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 medical 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.