1.1 本指南涵盖了用于生物医学应用的固体和溶液形式的热塑性聚氨酯的评估。聚合物已经反应完成，不需要进一步的化学处理。 1.2 本指南中列出的测试和方法可在包含特定最终用途产品的最低要求值和公差的规范中引用。 1.3 生物相容性的标准测试包括在内，以帮助评估生物医学应用中的安全使用。遵守这些标准不应被解释为对不可植入性的认可。由于固体和溶液形式的热塑性聚氨酯的许多成分、配方和形式都属于这一材料类别，配方设计师或制造商必须在预期用途和完成所有制造过程（包括灭菌）后评估特定成分或形式的生物相容性。 1.4 采购规范可由买方和卖方通过选择适用于特定生物医学最终用途的适当测试和方法来制定。 1.5 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 =====意义和用途====== 4.1 本指南旨在帮助设备制造商为其应用选择合适的市售聚氨酯固体和溶液。 4.2 本指南涵盖的聚氨酯可以热成型或溶液浇铸到生物医学设备中，用作手术辅助工具或根据支持的生物相容性和物理测试数据确定适当的植入。

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, 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. ====== 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 by this guide may be thermoformed or solution cast into biomedical devices for use as surgical aids or for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data.