1.1 本试验方法涵盖了一种比较用于帮助固定软组织附着的组织粘合剂的伤口闭合强度的方法。通过适当选择基材，它也可用于制造用作组织粘合剂的医疗器械的质量控制。 1.2 以国际单位制表示的值应被视为标准值。本标准不包括其他计量单位。 1.3 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。 1.4 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 至少部分通过粘附活组织发挥作用的材料和装置在外科手术中越来越多地被用作缝合线和吻合钉的附件，或者在各种医疗程序中作为这些装置的坦率替代品。虽然所涉及的力的性质和大小因适应症和患者的具体情况而异，但所有用途都在一定程度上涉及材料抵抗施加的机械力的能力。因此，材料的机械性能，特别是粘合性能，是评估其使用适用性的重要参数。此外，给定粘合剂组合物的机械性能可以为质量控制提供确定产品一致性的有用手段，或者作为在使用设备之前确定各种表面处理对基材影响的手段。 4.2 组织粘合装置的单个应用的复杂性和多样性，即使在单一指定用途（手术程序，其本身可能因物理部位和临床意图而异）内，也使得在不彻底分析和理解应用、粘合行为和临床适应症的情况下，单次抗拉强度测试的结果不适合确定允许的设计应力。 4.3 该测试方法可用于比较粘合剂或粘合工艺对疲劳、失效模式和环境变化的敏感性，但必须非常谨慎地进行此类比较，因为不同的粘合剂可能对不同的条件有不同的反应。 4.4 尚未建立测试方法结果与活体人体组织中实际粘合性能的相关性。

1.1 This test method covers a means for comparison of wound closure strength of tissue adhesives used to help secure the apposition of soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of medical devices used as tissue adhesives. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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. 1.4 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 vary 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 properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive 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 tissue adhesive devices, even within a single indicated use (surgical procedure, which itself may vary depending on physical site and clinical intention), is such that the results of a single tensile strength test is not suitable for determining allowable design stresses without thorough analysis and understanding of the application, adhesive behaviors, and clinical indications. 4.3 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue, mode of failure, and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions. 4.4 A correlation of the test method results with actual adhesive performance in live human tissue has not been established.