1.1 该试验方法提供了一种比较软组织密封剂爆裂强度或破裂强度的方法。该测试方法可用作不同粘合剂或被粘物的质量保证、开发和比较测试的临床相关模型。 1.2 该测试方法仅测量粘合剂/被粘物系统的破裂强度或“内聚强度”，而不测量粘合强度。 1.3 以SI单位表示的值将被视为标准值。本标准不包括其他计量单位。 1.4 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。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法规限制的适用性。1.5 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》中确立的国际公认的标准化原则制定的。 ======意义和用途====== 4.1 至少部分地通过粘附到活组织起作用的材料和装置在外科手术中发现越来越多的用途，或者作为缝合线和钉的辅助物，或者作为这些装置在各种各样的医疗手术中的直接替代物。虽然所涉及的力的性质和大小随适应症和患者特定情况而有很大变化，但所有用途在某种程度上都涉及材料抵抗施加的机械力的能力。因此，材料的机械性能，特别是粘合和内聚性能，是评价其适用性的重要参数。此外，给定密封剂组合物的机械性能可以提供用于质量控制的确定产品一致性的有用手段，或者作为用于在使用装置之前确定各种表面处理对基材的影响的手段。 4.2 密封剂单独应用的复杂性和多样性，甚至在单个指示用途（外科手术）内，使得在没有对应用和密封剂行为进行彻底分析和理解的情况下，爆裂测试的结果不适合于确定允许的设计应力。 4.3 该测试方法可用于比较密封剂对环境变化的敏感性，但必须非常谨慎地进行此类比较，因为不同的密封剂可能对不同的条件做出不同的响应。4.4 由于真正的密封剂强度很大程度上取决于密封剂/基底界面的强度，因此选择合适的测试基底是至关重要的。外推时必须小心 体外 测试结果至 体内 期望。 体外 密封剂优化可能无法转化为预期 体内 由于基材表面、强度和弹性的差异而导致的性能。

1.1 This test method provides a means for comparison of the burst or rupture strength of sealants on soft tissue. This test method can be used as a clinically relevant model for quality assurance, development, and comparative testing of different adhesives or adherends. 1.2 This test method measures only burst strength or “cohesive strength” of an adhesive/adherend system, and not the adhesive strength. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures, either as adjuncts to sutures and staples or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient-specific circumstances, all uses involve, to some extent, the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive and cohesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given sealant composition can provide a useful means of determining product consistency for quality control, or as a means for determining the effects of various surface treatments on the substrate prior to use of the device. 4.2 The complexity and variety of individual applications for sealant, even within a single indicated use (surgical procedure), is such that the results of a burst test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and sealant behaviors. 4.3 This test method may be used for comparing sealants for susceptibility to environmental changes, but such comparisons must be made with great caution since different sealants may respond differently to varying conditions. 4.4 As the true sealant strength is strongly dependent on the strength of the sealant/substrate interface, the selection of a proper test substrate is critical. Care must be taken when extrapolating in vitro test results to in vivo expectations. In vitro sealant optimization may not translate to expected in vivo performance due to differences in substrate surface, strength, and elasticity.