1.1 本试验方法涵盖医用纺织品（例如手术网、薄膜和薄膜）弯曲刚度特性的测量。测量弯曲长度并计算弯曲刚度。 1.2 本试验方法可用于可吸收或非可吸收医用纺织品。 1.3 本试验方法测量室温下空气中的弯曲刚度，如果直接使用，可能无法准确测量 体内 植入式医用纺织品的行为。 1.4 本试验方法不适用于测试管状样品。 1.5 以国际单位制表示的数值应视为标准值。括号中的值仅供参考。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 考虑医用纺织品的抗弯刚度很重要，因为这些设备通常需要具有易于符合其设计用于支撑或保护的解剖结构的特性。本试验方法概述了沿不同织物方向（即机器和交叉机器）测定弯曲性能以及测定织物表面取向（即正面和背面取向）影响的材料和方法。 5.2 本试验方法可用于质量控制目的。 5.3 本试验方法可用于非吸收性、吸收性和部分吸收性医用纺织品，包括薄膜和膜。应在干燥和适当处理的样本上进行测试。如果样品由可水解降解的可吸收材料制成或含有可吸收成分，则应使用测试方法在适当的时间间隔进行水解调节后的测试 F1635 . 对于部分可吸收纺织品，应至少在两个时间间隔内进行测试，该时间间隔超过可吸收成分不再对试样的可测量机械性能作出贡献的点。 5.4 如果发现弯曲刚度值显示与平面和表面方向相关的影响，则该测试方法的结果可能有助于确定设备是否应植入或仅在特定纺织方向和表面方向上使用。 确定使用的装置平面和表面方向的考虑因素包括但不限于植入后或使用期间的主要弯曲方向、将与装置相互作用的解剖结构以及装置在使用期间将经历的生理负荷（正常、病理和最坏情况）。 5.5 没有证据表明弯曲长度取决于宽度。然而，试样卷曲或扭曲的趋势可能会通过边缘提供的刚度影响结果。因此，使用更大宽度的试样有助于减少这种边缘效应。 5.6 本试验方法不同于试验方法 D1388 因为它需要跟踪样品表面方向，包括可吸收和部分可吸收医用纺织品。使用这种悬臂弯曲方法测量刚度高于的医用纺织品应考虑使用测试方法中所述的悬臂梁方法进行评估 D747 .

1.1 This test method covers the measurement of flexural stiffness properties of medical textiles (for example, surgical mesh, films, and membranes). Bending length is measured and flexural rigidity is calculated. 1.2 This test method may be used for absorbable or non-absorbable medical textiles. 1.3 This test method measures the flexural stiffness at room temperature in air and, if used directly, may not provide an accurate measure of in-vivo behavior for implantable medical textiles. 1.4 This test method is not suitable for testing tubular samples. 1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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 ====== 5.1 Consideration of the flexural stiffness of medical textiles is important, as these devices often need to possess properties that allow them to conform readily to the anatomic structures they are designed to support or protect. This test method outlines the materials and methods for the determination of flexural properties along the different textile directions (that is, machine and cross-machine) and for the effects of textile surface orientation (that is, face and back orientations). 5.2 This test method can be used for quality control purposes. 5.3 This test method can be used for non-absorbable, absorbable, and partially absorbable medical textiles including films and membranes. Testing should be performed on both dry and appropriately conditioned specimens. If the specimen is fabricated from a hydrolytically degradable absorbable material or contains an absorbable component, testing after hydrolytic conditioning at appropriate time intervals should be undertaken using Test Method F1635 . For partially absorbable textiles, testing should be performed through at least two time intervals that exceed the point where the absorbable component no longer contributes to the specimen’s measurable mechanical properties. 5.4 If flexural rigidity values are found to show effects related to planar and surface orientation, results from this test method could potentially help in determining if devices should be implanted or used only at specific textile directions and surface orientations. Considerations for determining device planar and surface orientations for use would include, but are not limited to, primary direction of bending once implanted or during use, anatomic structures that will interact with the device, and physiologic loads (normal, pathological, and worst-case) the device would experience during use. 5.5 No evidence has been found showing that bending length is dependent on the width. However, the tendency for specimens to curl or twist can affect the result through the rigidity provided at the edge. Consequently, use of test specimens with greater width can help to reduce this edge effect. 5.6 This test method differs from Test Method D1388 in that it requires tracking of sample surface orientation and includes absorbable and partially absorbable medical textiles. Medical textiles with stiffness higher than is measureable using this cantilever bending method should consider evaluation using the cantilever beam method described in Test Method D747 .